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Generic drugs

Increasing the use of generic drugs is an anti-inflationary tactic

by Joan J. Dean on

We hear these days of alarming growth in inflation, especially in housing and gasoline. That dreaded “I” word permeates discussions as affordability becomes a dominant issue.

One area that could actually see prices drop, however, is our prescription drug coverage.

We are used to assuming that our health care system is better than that of our southern friends, but in reality Americans have over 90% of their prescription drugs filled with generics, whereas in Canada we we only have about 73%.

Generic drugs have the same ingredients, undergo the same rigorous testing and are just as safe and effective, the only difference is that they are more affordable than branded options. For example, if we increased our prescription drug coverage through generic drugs by just 1%, we could save more than $703 million.

This is a critical public policy area where governments could realize significant savings.

But it is also an area where consumers themselves, and employers, can make significant savings in this time of rising prices. Indeed, this is an area where HR personnel and others making decisions about employee drug plans have the opportunity to save money for everyone involved.

As one insurance broker recently noted, “I’ve never been able to convince a client to include the mandatory generic clause. Given the right information, my clients take this for granted. It is simply a question of education.

We need to make this “evidence” a reality by ensuring that all employers have generic drug substitution policies to encourage patients and prescribers to choose the most cost-effective drugs. This means that the drug plan would reimburse at cost a generic drug rather than a more expensive brand name option, which would result in savings for the employer and for the employee, who would obtain the same medical ingredients at a lower price. cost.

This change means that insurance coverage is further extended to reduce the employee’s out-of-pocket expenses. Such a change would maximize their shared dollars so everyone involved would have more money to redirect to other priorities.

Provinces in Canada deal with designating generic drugs as “interchangeable” with branded versions, and many insurers rely on public formulary listings for mandatory generic substitution policies. Provinces should do a better job of making generic substitution more readily available so that patients and employers can realize this savings potential.

Specifically, in Saskatchewan and Manitoba, interchangeability is limited to publicly funded drugs, which limits access to low-cost generic versions of prescription drugs not covered by government drug plans. Meanwhile, British Columbia, Alberta, Quebec and New Brunswick, for example, leave this decision to the discretion of pharmacists, and only drugs listed on formularies are automatically included.

Instead, we need all provinces to allow generic substitution to be readily available so employees and employers can save money on their drug plans.

As Manulife said, “When it comes to your prescription drugs, why pay more than you have to?

Jim Keon is president of the Canadian Generic Pharmaceutical Association.

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Generic drugs

The pros and cons of generic drugs explored

by Joan J. Dean on

A patient who takes lorazepam (a generic version of Ativan) for her anxiety tells me that her medications have not worked as before in the past few months. She can’t identify what’s wrong, but she doesn’t like how it makes her feel. She thinks to herself that the pharmacy must have changed providers, but that shouldn’t really matter, because aren’t all generics supposed to work the same? Zoom in on some of the often overlooked facts about generic drugs.

What are generic drugs?

When a new drug is approved, it is patented for up to 20 years, giving the original manufacturer time and space in the market to recoup some of the costs of research and discovery. When the patent expires, other companies are allowed to manufacture a similar drug (a generic) that is “bioequivalent”, which means that it delivers the same active ingredient to the same part of the body, over the same length of time. than the original drug.

Are Generic Drugs Less Expensive?

The cost of producing a generic is much cheaper than the original, and competition from several manufacturers drives the price down even further. The price difference is greatest for drugs whose patents have long expired and whose market is dominated by generics. For example, the average monthly retail price of lorazepam is $ 24, compared to $ 1,386 for Ativan.

Insurance companies encourage patients to choose generics with a lower co-payment and sometimes categorically refuse to cover brand-name drugs. On the other hand, pharmaceutical companies are offering coupons and discounts to offset the direct cost of brand name drugs in order to maintain their market share.

Following:Health Matters: Let the Data Talk – Follow-up Questions on COVID Vaccines

Who takes the generic drugs?

Almost everybody. In 2020, 90% of all prescriptions in the United States were filled with generics, and that number has steadily increased since the Drug Price Competition and Patent Term Restoration Act of 1984. (also known as the Hatch-Waxman Act) opened the regulatory valve. in the manufacture of generic drugs. It is estimated that the use of generic drugs has saved Americans $ 313 billion a year in health care costs.

Are there any downsides to generics?

Quality control is a major concern. Companies reduce their costs by outsourcing production; the vast majority of generic drugs in America are made in India and China, while others rely on raw ingredients from these countries. Factories are not as frequently inspected by the FDA as those located in the United States and may not maintain the same level of production. Some unethical companies have even tampered with data to gain regulatory approval. In 2008, a Chinese batch of contaminated heparin, a crucial blood thinner for open heart surgery, killed at least 81 patients in America and injured hundreds more. Fortunately, these disasters are rare.

More often than not, we see inconsistencies in the quality of generics and, therefore, in their biological effects. Unlike the single-source brand name drug, generics are produced by more than one company in more than one location. Pharmacies change supplier freely depending on price and / or availability. Even though the concentration of the active chemical remains the same, changing inactive ingredients like fillers, binders, and dyes can cause different reactions when you take the pill.

Following:Don’t let the winter blues get you down, here’s how to stay cheerful in the dark months

What should I do if my generic is not working properly?

There are several options. Ask the pharmacist if a version of the medicine from the previous supplier is still available. Change your pharmacy, which will likely change providers. Some drugs have an “authorized generic” which is exactly the same as the brand name, produced by the same company and factory, but sold without the brand name. It is more expensive than other generics, but has quality assurance from the original pharmaceutical company. If you develop a true allergy or severe intolerance to generics, ask your doctor to specify “brand name only” on the prescription, although this may require passing certain hurdles for insurance to pay for it.

Usually we don’t look twice at the pill bottle after filling a prescription. But as we strive to become more informed healthcare consumers, we hope this generic drug information will encourage you to take a closer look, and perhaps say “Yes” when the pharmacy cashier tells you. ask if you have any questions for the pharmacist about your medicine.

Qing Yang and Kevin Parker are a married couple living in Springfield. Dr. Yang received her medical degree from Yale University School of Medicine and completed her residency at Massachusetts General Hospital. She is an anesthesiologist at HSHS Medical Group. Parker has helped formulate and administer public policy in various cities and state governments across the country. He was previously the Group Information Director for Education at the Illinois Department of Innovation and Technology. This column is not intended to be a substitute for professional medical advice, diagnosis or treatment. Opinions are those of the authors and do not represent the views of their employers.

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Generic drugs

Generic Drugs Authorized “Insufficient” to Improve Affordability of Medicare Part D

by Joan J. Dean on

20 October 2021

2 minutes to read

Source / Disclosures

Disclosures: The authors do not report any relevant financial disclosures.


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Generic drugs licensed for insulin and direct-acting antiviral agents may reduce out-of-pocket expenses for patients, but are unlikely to save money for Part D plans or Medicare, according to the data.

“Compared to brand name drugs, authorized generic versions of direct-acting antiviral agents for hepatitis C and insulin are said to have resulted in lower out-of-pocket expenses for Medicare beneficiaries.” Stacie B. Dusetzina, PhD, associate professor of health policy and Ingram associate professor of cancer research at Vanderbilt University School of Medicine in Nashville, Tennessee, and colleagues wrote in JAMA Internal Medicine. “However, coverage for authorized generic drugs was limited for some Part D beneficiaries, with many beneficiaries covered by plans covering only brand name drugs. For Part D plan sponsors, this decision likely reflects rational economic behavior, as the net prices (after rebates) of brand name drugs in these classes may be similar to or lower than the net prices of authorized generic drugs.

Various colorful pills
Source: Adobe Stock

As Healio previously reported, manufacturers of insulin and direct-acting antiviral agents for the treatment of hepatitis C have recently introduced authorized generic alternatives to their patented branded products at a time when brand name drugs faced no immediate threat of generic competition. Authorized generic drugs have list prices at least 50% below the list price of brand name drugs; the announcements followed close scrutiny in Congress on high drug prices.

In a cross-sectional study, Dusetzina and colleagues analyzed data from the Medicare Prescription Drug Plan form and third quarter 2020 pricing information files and Medicare Part D enrollment for September 2020. Researchers assessed the coverage of four branded formulations of direct-acting insulin and antivirals and their authorized generic formulations: sofosbuvir and velpatasvir fixed-combination tablets (Epclusa, Gilead), ledipasvir and sofosbuvir tablets (Harvoni, Gilead), insulin lispro (Humalog, Eli Lilly) and insulin aspart (Novolog, Novo Nordisk).

“We selected these drugs because we believe they are the only ones to have launched generic formulations authorized more than a year before the expected expiration of the patent and have faced no traditional generic competition in the third quarter of 2020. “the researchers wrote.

The main results were the weighted coverage of the formulary by beneficiaries of branded products and authorized generics; disbursements by the beneficiary; and the prepayment plan, manufacturer and Medicare expenses on branded products and authorized generics.

As of the third quarter of 2020, 97% of beneficiaries were on plans that covered only brand name drugs or both brand name drugs and authorized generics. About 3% of beneficiaries were on plans that covered only authorized generic drugs.

The researchers found that the list prices of authorized generic drugs were 67%, 62% and 50% lower than the list prices of Epclusa, Harvoni and each branded insulin product, respectively. “Medicare beneficiaries using licensed generics could save $ 270 per year for 12 vials of Humalog and $ 2,974 for a full treatment of Harvoni,” the researchers wrote.

The plans, however, have limited incentives to encourage the use of authorized generics; discounts for brands likely exceed savings available with authorized generics, especially for beneficiaries whose spending reaches the Medicare Part D coverage gap.

“Ultimately, the availability of licensed generic options for products that do not face traditional generic competition is insufficient to improve affordability for Medicare beneficiaries,” the researchers wrote. “The results of this study suggest that efforts to change Medicare Part D benefits should also ensure that incentives for plans and beneficiaries are properly aligned and that beneficiaries are not paying too much for drugs that are better.” value for their health plan and Medicare program. “

Perspective

Back to the top

David C. Robbins, MD

I appreciate the extraordinary costs of bringing drugs safely to the consumer. I am troubled by the economic burdens faced by people with diabetes who must have constant access to their medications. Insulin, a biologic, costs more to manufacture and safely administer than many generic drugs, but these costs barely explain the sticker shock many underinsured patients face.

As a clinician, I spend an inordinate amount of my time browsing a maze of insurance coverages and ordering less desirable, but more affordable, alternatives for my patients. Denying patients these treatments is often shortsighted. We are forced to use older, less effective drugs at the cost of an increased risk of crippling complications such as blindness and kidney failure. From a stratospheric public health perspective, this is insane and insane. We are reducing the huge costs of future complications rather than focusing on savings from prevention.

I have read many articles on how the supply chain seems to increase the cost of insulin, but still cannot understand the extraordinary prices faced by consumers whose lives depend on these drugs. Too many of my patients reduce their insulin doses, share them with other family members, or skip them altogether.

Generic insulins will never join the $ 4 a month club, but they will provide healthy competition in a protected market and be welcomed by healthcare providers and their patients. Doctors-in-training at most teaching hospitals have little or no experience with cheaper insulins since the hospital formulary comes exclusively with brand name products. I suspect that drug companies are deliberately providing them at very low cost, inadvertently putting the hospital in the position of promoting more expensive drugs since patients are discharged on those same insulins. Newly trained physicians inadvertently become pawns in the high cost of drugs with little [if] any exposure to the promotion and use of lower cost alternatives. Providers and patients should be made aware that cheaper insulin does not necessarily mean less effective diabetes control.

Medicare could be the 800-pound gorilla when it comes to insulin pricing by competitively pricing and having the courage to stand with the consumer rather than the drug companies.

David C. Robbins, MD

Bud and Sally Cray Professor of Diabetes

Director, University of Kansas Diabetes Institute

Disclosures: Robbins claims to own shares in Eli Lilly.


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Medical products

Medical Products Supply Chain Weekly Review – October 2021 # 1 | Alston & Bird

by Joan J. Dean on

Last week, AstraZeneca and Merck filed Emergency Use Authorization (EUA) applications for their COVID-19 drugs. The FDA has provided information to the public on a database repository of genetic variants and associated conditions. The United States, along with 135 other countries, have agreed to an overall minimum tax of 15%. Please see details of these and other supply chain developments below:

  • On October 5, AstraZeneca filed an EUA application for its COVID-19 long-acting antibody (LAAB) prophylaxis, AZD7442, composed of tixagevimab and cilgavimab. Although the LAAB combination is under investigation for prophylactic and therapeutic purposes, the EUA’s request was for its prophylactic use against symptomatic COVID-19. Two phase III trials have shown a reduction in the relative risk of symptomatic COVID-19 by 77% and 33%. The data suggests that the drug is also effective against variant strains. On October 11, AstraZeneca also released a press release revealing high-level results from another Phase III trial. The trial showed a reduction in the rates of severe COVID-19 or death in the treatment group, compared to the placebo group, in out-of-hospital participants with mild to moderate symptoms.
  • On October 5, the FDA released a final rule on the De Novo medical device classification process. The rule establishes procedures and criteria for submitting and withdrawing a De Novo application and how the FDA will assess the application. Based on the new rule, the agency updated the following guidance documents:
    • The final guidelines “FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals” provide sponsors with information on decision points and deadlines that the FDA will meet when reviewing a De Novo application. .
    • The final guide “De Novo Classification Process (Evaluation of Automatic Class III Designation)” provides guidance to sponsors whose device is automatically classified as Type III based on a determination that the device was not substantially equivalent to a predicate device via process 510 (k).
    • The final guide “Usage Fees and Refunds for De Novo Classification Requests” provides sponsors with information on De Novo classification requests requiring a fee, requests that are exceptions, and the refund process.
  • On October 7, the FDA’s Center for Devices and Radiological Health released a Description of Public Human Genetic Variant Databases, a repository of genetic variants and related diseases or conditions. The FDA’s goal is to help manufacturers develop tests for these diseases or conditions by providing FDA-recognized databases that contain data and claims, which can be used to support regulatory review of the FDA. The FDA considers the available databases to be scientifically valid.
  • On October 8, the United States, along with 135 other countries, approved an overall minimum corporate tax rate of 15%. Multinational companies have transferred their business infrastructure and interests to foreign countries with the lowest tax requirements. Countries with a stricter tax code, such as the United States, may benefit. The goal is to keep business interests in their home country and boost local economies.
  • On October 11, Merck filed an EUA application for its COVID-19 oral antiviral drug, molnupiravir. The request comes after interim results from the Phase III clinical trial demonstrated a positive benefit: severe hospitalization and death rates were reduced in the treatment group. If approved, the drug would be the first oral antiviral drug to treat COVID-19 that patients can take at home.
  • On October 12, the FDA announced it was withdrawing three guidance documents: “Temporary Policy for the Preparation of Certain Alcohol-Based Hand Sanitizers During Public Health Emergency (COVID-19)”, “Policy for the temporary composition of certain alcohol-based products for the hands Disinfectant products during a public health emergency” and “Temporary policy for the manufacture of alcohol to be incorporated into disinfectant products for the hands based on alcohol during the public health emergency (COVID-19). ”The manufacture of affected products must cease by December 31, 2021 and distribution by March 31, 2022. The agency determined that the urgent need to temporary orders no longer exist as the supply of alcohol-based disinfectants by “traditional” manufacturers can meet demand.

[View source.]

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Medical products

FDA awards 11 clinical trial grants to develop new medical products for treatment of rare diseases

by Joan J. Dean on
For immediate release:

Today, the United States Food and Drug Administration announced that it has awarded 11 new research grants for clinical trials, equivalent to more than $ 25 million in funding over the next four years. The FDA’s congressionally-funded Orphan Products Grants program awards these grants to clinical researchers to support the development of medical products for patients with rare diseases.

“Supporting the development and evaluation of new treatments for rare diseases is a critical part of the FDA’s mission,” said Janet Woodcock, Acting Commissioner of the FDA. needs of those suffering from a rare disease.

Grants awarded support clinical studies of products that address unmet needs in rare diseases or conditions or that provide very significant improvements in treatment or diagnosis.

Many of these studies involve children, as young as newborns, including one evaluating the treatment of a rare inherited skin disease known as recessive dystrophic epidermolysis bullosa, or RDEB, a condition that can lead to severe painful blisters and sores that are often disfiguring and fatal. Another study aims to assess early treatment before seizures appear in infants with tuberous sclerosis, which is an inherited disease that can affect various organs and lead to long-term brain development problems. This grant also includes an innovative demonstration project that will use a collaborative approach to evaluate a tool with the potential to improve data accuracy for clinical trials taking place in more than one location.

Some of the new awards fund clinical studies of products for use in brain cancer. More specifically, we will evaluate a new peptide vaccine to treat pediatric brain cancers. The vaccine is designed to be directed specifically at tumor areas of the brain and has the potential to have a significant impact on how these rare and fatal tumors are treated.

“The Orphan Product Development Office strives to identify, review and ultimately fill the gaps that exist within the rare disease drug development community by funding the necessary clinical studies.” and groundbreaking in determining the safety and effectiveness of potential treatment options, ”said Sandra Retzky, DO, JD, MPH, Director of OOPD. “These grants demonstrate the FDA’s commitment to supporting the development of new treatments for patients living with rare diseases.

Here is a complete list of grants in alphabetical order:

  • Armgo Pharma, INC. (Ardsley, New York); Eugene Marcantonio; Phase 2 study of S48168 (ARM210) for the treatment of catecholaminergic polymorphic ventricular tachycardia type 1 (CPVT1); $ 1 million over two years
  • Boston Children’s Hospital (Boston, Massachusetts); Mark Puder; RELiZORB Phase 3 Study for the Treatment of Short Bowel Syndrome; $ 2.7 million over four years
  • Castle Creek Biosciences, LLC (Exton, Pa); Mary Spellman; Phase 3 study of FCX-007 (genetically modified autologous human dermal fibroblasts) for the treatment of recessive dystrophic epidermolysis bullosa; $ 1.8 million over four years
  • Cincinnati Children’s Hospital Medical Center (Cincinnati, Ohio); Darcy Krueger; Phase 2b study of sirolimus for the prevention of epilepsy in patients with tuberous sclerosis Bourneville; $ 5 million over four years
  • Cincinnati Children’s Hospital Medical Center; Michael Jordan; Phase 2 study of abatacept for the treatment of common variable immune deficiency associated with interstitial lung disease (ABCVILD); $ 3.1 million over four years
  • Duke University (Durham, North Carolina); Eric Thompson; Phase 2 study of a peptide vaccine targeting CMV antigen for the treatment of newly diagnosed high-grade pediatric glioma, diffuse intrinsic pontine glioma and recurrent medulloblastoma; $ 1.8 million over four years
  • Massachusetts General Hospital (Boston, Massachusetts); Amy Dickey; Phase 2 study of oral cimetidine for the treatment of protoporphyria; $ 1.6 million over four years
  • Mayo Rochester Clinic (Rochester, Minnesota); Sani Kizilbash; Phase 1 study of WSD0922-FU for the treatment of high-grade astrocytoma; $ 1 million over three years
  • Mayo Rochester Clinic (Rochester, Minnesota); singer Wolfgang; Phase 2 study of autologous mesenchymal stem cells administered intrathecally for the treatment of multisystem atrophy; $ 3.2 million over four years
  • Reveragen Biopharma, Inc .; Eric Hoffman; Phase 2a study of vamorolone for the treatment of Becker’s muscular dystrophy; $ 1.2 million over two years
  • University of Florida (Gainesville, Florida); Peter Stacpoole; Phase 2A trial of dichloroacetate for the treatment of glioblastoma multiforme; $ 2.5 million over four years

As challenges and rising costs have continued this year for clinical trials due to the COVID-19 pandemic, the FDA remains committed to supporting rare disease research by providing existing recipients with additional funding. These resources allow ongoing studies to take the necessary steps to allow their research to continue and to ensure the safety of study participants, maintain compliance with good clinical practice, and minimize risk to the patient. integrity of tests.

Related information

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master key

The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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Generic drugs

Generic Drugs Market Growth of USD 138.90 billion from 2021 to 2025 | Technavio

by Joan J. Dean on

Read our free sample report to make the most of future growth opportunities.

The Generic Drugs Market report offers a comprehensive analysis of the strategies adopted by the vendors and the trends, drivers and challenges affecting the market size. The report identifies the low cost alternatives as one of the major growth factors of the market. The advent of RPA, the increase in mergers and acquisitions, and hospital-owned generics will be some of the market trends over the next few years.

The generic drugs market covers the following areas:

Sizing of the generic drug market
Generic Drugs Market Forecast
Generic Drugs Market Analysis

Companies mentioned

  • Amgen Inc.
  • Dr. Reddys Laboratories Ltd.
  • Fresenius SE and Cie KGaA
  • Merck et Cie Inc.
  • Novartis AG
  • Pfizer Inc.
  • Sanofi SA
  • Sun Pharmaceutical Industries Ltd.
  • Teva Pharmaceutical Industries Ltd.
  • Viatris inc.

Subscribe to our “Lite Package” billed annually at 3000 USD to view 3 reports per month and download 3 reports per year.

Associated reports:

  • Lung Cancer Therapeutics Market by Type and Geography – Forecast and Analysis 2021-2025: The lung cancer treatment market has the potential to grow by $ 6.79 billion from 2021 to 2025. Download a free sample exclusive report
  • Interstitial Cystitis Drugs Market by Type and Geography – Forecast and Analysis 2021-2025: The market for interstitial cystitis drugs has the potential to grow by $ 283.95 million from 2021 to 2025. Download a free sample report

Scope of the generic drug market

Cover of the report

Details

Page number

120

Year of reference

2020

Forecast period

2021-2025

Growth dynamics and CAGR

Accelerate to a CAGR of 6.33%

Market growth 2021-2025

$ 138.90 billion

Market structure

Fragmented

Annual growth (%)

5.95

Regional analysis

North America, Europe, Asia and ROW

Efficient contribution to the market

North America at 39%

Main consumer countries

United States, Germany, China, Japan and United Kingdom

Competitive landscape

Leading companies, competitive strategies, reach of consumer engagement

Profiled companies

Amgen Inc., Dr. Reddys Laboratories Ltd., Fresenius SE and Co. KGaA, Merck and Co. Inc., Novartis AG, Pfizer Inc., Sanofi SA, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd. and Viatris Inc..

Market dynamics

Parent Market Analysis, Market Growth Drivers and Obstacles, Analysis of Fast Growing and Slow Growing Segments, Impact of COVID 19 and Future Consumer Dynamics, Analysis of Market Conditions for the Forecast Period,

Customization

If our report didn’t include the data you’re looking for, you can reach out to our analysts and customize the segments.

About Us
Technavio is one of the world’s leading technology research and consulting companies. Their research and analysis focuses on emerging market trends and provides actionable insights to help companies identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialist analysts, Technavio’s report library includes over 17,000 and more reports, spanning 800 technologies, spanning 50 countries. Their customer base consists of companies of all sizes, including more than 100 Fortune 500 companies. This growing customer base relies on Technavio’s comprehensive coverage, in-depth research and actionable market intelligence to identify opportunities in existing markets. and potentials and assess their competitive positions in changing market scenarios.

Contact
Technavio research
Jesse maida
Communication and Marketing Officer
United States: +1 844 364 1100
United Kingdom: +44 203 893 3200
E-mail: [email protected]
Website: www.technavio.com/

SOURCE Technavio

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Prescription drugs

DEA investigation into Ryan Vermillion linked to prescription drug cashout

by Joan J. Dean on

Vermillion, who worked with Washington coach Ron Rivera for nine seasons as the Carolina Panthers’ head athletic coach before joining him in Washington in January 2020, has been placed on administrative leave by the team at the middle of the criminal investigation.

Vermillion’s attorney, Barry Coburn of the Washington law firm Coburn & Greenbaum, declined to comment on Thursday. NBC Sports Washington was the first to report that the federal investigation is related to prescription drugs.

Around 3 p.m. Friday, about two dozen DEA agents and Loudoun County law enforcement officers executed search warrants at the team’s training facility in Ashburn, Va., along with at Vermillion’s nearby home, according to several people familiar with the situation. Some team and player staff were at the facility when officers arrived in unmarked cars and searched an area of ​​the training facility that related to Vermillion and the drug disbursement.

NFL teams typically employ multiple physicians who often specialize in orthopedic surgery and have their own practices separate from their football work. These physicians travel with the teams and work in conjunction with full-time club athletic trainers and strength and conditioning coaches. They are supposed to manage the dispensing of prescription drugs.

The DEA’s investigation is not the first involving an NFL team or its medical staff and the unauthorized distribution of prescription drugs.

In 2014, the DEA, in conjunction with the Transportation Security Administration, conducted surprise inspections of several NFL medical teams, including those of the San Francisco 49ers, Seattle Seahawks, and Tampa Bay Buccaneers. The investigations focused on the possible disbursements of medicines without a prescription or label as well as on the dispensing of medicines by the trainers.

These investigations were prompted by a class action lawsuit brought by more than 1,300 former NFL players who claimed team medical staff liberally dispensed narcotics and the nonsteroidal anti-inflammatory drug Toradol to help keep players in the field. Players at the time described instances in which they were given dangerous concoctions of drugs and recalled coaches handing out pills in hotels, locker rooms and on team planes, among other violations.

In 2010, the DEA investigated the then San Diego-based Chargers after safety Kevin Ellison was caught with 100 Vicodin pills during a traffic stop. In 2013, the New Orleans Saints were fined after security footage showed a flying Vicodin coach in 2010.

On Wednesday, Washington safety Landon Collins, who serves as the team’s player representative for the NFL Players Association, was asked by reporters about his experience with Vermillion.

“It was great. it was beautiful,” said Collins, who suffered a season-ending Achilles tendon injury last year. “A great guy, a humble guy, very respectful. It helped me a lot in this situation, especially with the return of my injury. Just a great guy overall.

The NFLPA released a statement on Wednesday saying it had requested more information from the NFL about the search of Washington facilities because the matter “directly affects the health and safety of players.” On Thursday, the players’ union sent a letter to all certified players’ agents saying it had informed the NFL that it was investigating the DEA searches. In the letter, the NFLPA noted that a player had been contacted by the DEA.

The Washington Football Team said in a statement Monday that the investigation was “not team related.” Rivera referred to the team’s statement when speaking to local reporters on a video conference call this afternoon, but told NBC Sports Washington that “I know who Ryan is, and last year I trusted Ryan with my health and would do it again.” Rivera was diagnosed with cancer in 2020 and underwent treatment throughout last season.

In April, healthcare provider Inova and Robin West, an orthopedic and sports medicine surgeon who served as the Washington team’s chief medical officer, announced the end of their medical partnerships with the team. Anthony Casolaro is Washington’s chief medical officer/internal medicine, and Chris Annunziata is the team’s chief medical officer/orthopedics. Washington has eight other doctors on its medical team.

Rivera said the team will operate “pretty much by committee” in Vermillion’s absence. Bubba Tyer, who retired as Washington’s director of sports medicine in 2009, attended practices this week to help assistant sports coaches.

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Generic drugs

Generic drugs are cheaper in the US, but quality control can be a problem, says professor | WFAE 90.7

by Joan J. Dean on

Every week through October, we examine the medical, business, and cultural systems that contribute to the dichotomy that is America’s healthcare system — a system that benefits some but costs us all.

Today we are looking at generic drugs. You may have heard that they are cheaper than brand name drugs and they are just as good, right? Well, changes are afoot in the industry that are testing this long held theory. Dr. Kevin Schulman is a professor of medicine at Stanford University and has studied this question extensively.

Marshal Terry: Welcome.

Kevin Schulman: Thank you very much for inviting me.

Terri: Conventional wisdom has long held that generic drugs are the same as brand name drugs. Is this assumption wrong?

Schulman: They are the same chemical entity. What we learn is that over time, the question we ask ourselves is the quality of the drugs. How are they made? Are they made to the same standards as the original brand name drug?

Terri: And what is the answer to that?

Schulman: Unfortunately, we find that often they fail. There are large classes of drugs — generic drugs — that have been recalled in the past two years because they contain carcinogens that were not suitable for drugs. And that just opens up the question: what’s going on in the generic drug market? How do we understand both the price and the quality of the drugs we receive?

Terri: Well, what’s going on with the generic drug market? What leads to this?

Schulman: Thus, the idea of ​​generic drugs dates back to 1984 with what is called the Hatch-Waxman Act. At the time, the idea was to allow generic drugs into the US market to drive down the price of drugs, and it was mostly a price-driven set of issues. And it worked very well. In 1984, the generic drugs we got in the United States were mostly made in the United States and Europe. Today, these drugs are made overseas – maybe in India, maybe in China.

Our ability to regulate these manufacturers is very different, and the market itself has really changed dramatically. We had a huge concentration of intermediaries in the market — the drug distributors. And this puts enormous pressure on manufacturers’ prices. So today, yes, generic drugs are the cheapest ever. Sometimes the really important drugs are pennies. But this is purely a price market. There is no quality assessment. It’s like going to Amazon and saying, “Give me the cheapest good in any category without the quality rating.” And we all know what that leads to.

Terri: You said more of these generic drugs are now being made outside the United States — overseas, in places like China and India. How much more common is that?

Schulman: Around 2005, 2007, about 50% of all generic drugs in the United States were made overseas. And I think now…the majority of them are made overseas. There are different parts of the drug. The chemicals that go into the drug are almost all made overseas. And then whoever packages the drug and takes those active pharmaceutical ingredients and makes it into a pill or a tablet or a capsule—that’s also usually overseas.

“Yes, generic drugs are the cheapest they’ve ever been. Sometimes the really important drugs cost pennies. But it’s purely a price bargain. There’s no quality assessment. “

— Dr. Kevin Schulman, Professor of Medicine at Stanford University

Terri: Now, you mentioned that one of the concerns with this shift to more of these foreign-made drugs was a quality control issue. And the countries you mentioned—two of the biggest countries where these drugs are made, India and China. What is the scope of the FDA in regulating these drugs manufactured in these countries?

Schulman: Our FDA has the ability to audit US factories. What he needs to do is ask governments for permission to audit factories in India and China. In the United States we have secret inspections. The FDA shows up right at your doorstep and wants to inspect the plant. In India and China, he must ask permission and notify manufacturers that he is coming.

But more broadly… The FDA only inspects every two years. Meanwhile, the FDA has no idea what’s going on at an individual manufacturing plant. I mean, it’s no different than what we’ve seen in other industries that have outsourced. The idea of ​​the FDA monitoring all potential sources of molecules for the US market is really, really hard to imagine.

Terri: Do these countries themselves have organizations equivalent to the FDA? Do they have their own version? And if they do, do they meet the same standards as our FDA?

Schulman: They have nascent institutions that are not at the same level as the United States. I don’t know how big the Chinese FDA was, but a few years ago it was 100 people. The problem here is the supply chain.

You would think that you would test some of these drugs — the suppliers would test or the distributors would test the drugs to make sure that the ones they dispense say what is on the label and that they are of good quality. Unfortunately, what we have seen is that this is not true. And the recalls that happened with these carcinogens in metformin and ranitidine – metformin is a first-line treatment for diabetes, and the FDA eventually recalled 40% of all drugs on the market because of these carcinogens. But the only way we found out about this was actually through a third-party testing organization looking into the issue.

So what’s happening today is that every new manufacturer of a generic drug has to offer a lower price to enter the market. And so prices have dropped, which is a good thing. But again, there is no quality consideration. And so, at a certain point, the market price is lower than the price that a high-quality producer can produce, and people leave the market. And so now we have this market where it’s basically the cheaper manufacturers that are supplying the drugs to the United States.

Terri: What can Americans do now to verify the quality of their generic drugs? Is there anything they can do?

Schulman: Unfortunately, at the moment there is really nothing they can do. But we can go back and say, “We don’t want to tolerate this. If we are paying for a medicine at a pharmacy, we want that pharmacy to assure us that it is a medicine that is made safely and of the highest quality, not the cheapest medicine available that they could find .

Terri: You support a generic drug rating system, similar to the ratings you see on Amazon.com. Even if we had a rating system that assigns, you know, one star, two stars, etc., can you really rate a pill the way you would, say, a vacuum cleaner or a toaster?

Schulman: Absoutely. I mean, there are very specific parameters. Is the dose on the label the actual dose? The quality of the pill, in terms of contaminants, is the quality of the pill there? And then are there other chemicals in the pill that you don’t want in the pill, like those carcinogens that have been found? So I think we can assess it. We can rate it as yes/no. Does it match the label? Is it within the standards? Or we can rate it 1-5. I think it is possible to do one or the other.

It’s really important not to scare off the American public. It is very important to take your medications. But if for a month your high blood pressure pill doesn’t work or you feel really bad when you take your medicine that you’ve been taking for a long time and you wonder if there’s something wrong with the pill, the only thing that I would say that it is quite possible these days that there is something wrong. You can go back to the pharmacy, get another manufacturer, and you can also ask the pharmacy, “Why don’t you give me a quality rating on this drug and a price?” »

Terri: Thank you for taking the time.

Schulman: Thank you very much.

Terri: Dr. Kevin Schulman is a professor of medicine at Stanford University and has extensively studied the changes affecting the generic drug industry.

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Medical products

Heritage Cannabis announces supply agreements and the first shipment of Opticann medical products to Australia

by Joan J. Dean on

TORONTO – (COMMERCIAL THREAD) – Heritage Cannabis Holdings Corp. (CSE: CANN) (OTCQX: HERTF) (“Heritage” or the “Company”), is pleased to announce that its subsidiary Opticann has signed two supply agreements with two well-established Australian companies for the supply of products based on medical cannabis. The first shipment of medical cannabis CBD / CBDA filmstrips totaling $ 60,000 has recently been completed.

As previously announced, Heritage has a limited exclusive agreement with IntelGenx Corp. (“IntelGenx”) (TSX V: IGX) (OTCQB: IGXT) for CBD film products based on IntelGenx VersaFilm® technology for the Canadian and Australian markets. In accordance with the agreement, Heritage is supplying the CBD raw material for the manufacture of IntelGenx film and the supply in Canada and Australia for distribution by Heritage.

Umar Syed, President of the Medical Division of Heritage, said: “Australia is an important and rapidly growing medical market as it is set to grow at over 30% CAGR by 2028 according to Grand View Research. Our Australian distribution partners have been carefully selected for their ability to develop the market for CBD products and monitor the evolution of TGA regulations, including a possible S3 classification which allows the distribution of over-the-counter CBD products. Our proprietary, Quick Dissolving Sublingual CBD Film Strips are unique (CB4 Control Film Strips in Canada) to provide medical patients with a rapid onset and maximum bioavailability of CBD compared to oral products. We are delighted to have completed our first shipments to Australia and plan to add additional products in the future. ”

“As we continue to develop our market and the distribution of our brand in Canada, it is important for us to monitor and act in new markets with a strategic approach in order to capitalize on new market opportunities,” said David Schwede, CEO of Heritage. “By partnering with these well-established companies in Australia, we can leverage their local knowledge and expertise, while minimizing the costs and risks of entering new markets. ”

The CBD filmstrips are produced at the IntelGenx manufacturing facility under Canadian GPP conditions and will be registered as a product for sale with the Therapeutic Goods Administration of the Australian Department of Health as medicinal cannabis.

About Opticann

Opticann’s CB4 medical cannabis product line is based on trusted pharmaceutical technology platforms that are optimized for the efficient delivery of cannabinoids – for maximum effect and to minimize unwanted effects.

Opticann’s patented and proprietary products are based on innovative pharmaceutical technology that delivers the best results consistently, safely, and in convenient dosage forms (capsules, sublingual and topical filmstrips). These dosage forms are tested and optimized to provide active ingredients for effective results. Opticann products also contain the highest quality ingredients and are rigorously tested for consistency.

About heritage

Heritage Cannabis is a leading cannabis company providing innovative products to the legal medical and recreational cannabis markets in Canada and the United States, operating out of two licensed manufacturing facilities in Canada. The company has an extensive portfolio of high-quality cannabis products under the brands Purefarma, Pura Vida, RAD, Premium 5, feelgood, CB4 medical product suite in Canada and ArthroCBD in the United States.

ON BEHALF OF THE BOARD OF DIRECTORS OF HERITAGE CANNABIS HOLDINGS CORP.

“David Schwede”

David Schwede

CEO

The Canadian Securities Exchange accepts no responsibility for the adequacy or accuracy of this release.

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Generic drugs

FDA Guidelines Cover Commonly Asked Questions from CMC for Generic Drugs

by Joan J. Dean on

Posted on September 21, 2021 | Through Joanne S. Eglovitch

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) on Monday released draft guidelines that provide generic drug applicants with answers to frequently asked questions in the area of ​​drug quality. medications. The new guidelines are designed to provide an immediate response to these questions to reduce the number of controlled matches on identical topics.

The guidelines, which are in the form of questions and answers, cover FDA policies on quality-related scientific and regulatory topics that “appear frequently” in vetted correspondence submissions from CDER’s Office of Pharmaceutical Quality. The intent of the guidelines is to help industry “move forward with certain generic drug development activities without the need to submit controlled correspondence to the FDA,” according to an email from the agency. September 20.

Under the Generic Drug User Fee (GDUFA II) changes, manufacturers who submit a question through the controlled match mechanism may wait up to 60 or 120 calendar days for a response, depending on the type of controlled correspondence, as the agency reiterated in its final version. guidance released last December (RELATED: Generics: FDA Finalizes Controlled Match Guidance, Regulatory guidance December 17, 2020).

The nine questions and answers contained in the guidelines to date are “derived from numerous vetted match submissions” and cover parenthesizing and mastering expectations, container closure changes, dissolution, testing for endotoxins, the number of lots of exhibits needed and the scoring and testing of split tablets. .

Some of these frequently asked questions and the answers from the FDA are as follows:

Bracketing and mastering

The FDA has clarified that a bracketing approach is acceptable for a multi-strength drug product, as long as the active and inactive ingredients are proportional to the dose.

The agency was responding to a question about whether it is acceptable to use a bracketing approach for manufacturing voucher lots of a generic drug with multiple strengths produced from granulations or bulk blends currents, and whether all of these batches should be placed on a stability program.

The guidelines specify that sponsors should produce three separate intermediate bulk batches, with one batch representing all proposed concentrations, one batch reflecting the lowest concentration, and one batch reflecting the highest concentration. For more information, sponsors should consult the May 2014 FDA guidance titled “ANDA: questions and answers on stability testing of drug substances and products.”

Container closing systems

A proposed generic drug need not have the same container closure system (CCS) as the reference product, the agency said in response to a question about whether a generic drug could be packaged in a bottle if the RLD is packaged in an ampoule.

Still, the application “must contain information to show that the proposed generic drug has the same terms of use and labeling, with certain permitted differences, as the RLD.”

Bacterial endotoxins

The guide provides answers to two questions related to bacterial endotoxins. The first answer relates to how an acceptance criterion for endotoxin testing should be determined for a finished pharmaceutical product. Here, the FDA directs generic developers to General Chapter 85 of the American Pharmacopoeiawhich defines the maximum endotoxin exposure for drugs in general and for topical and intrathecal drugs.

Topical ophthalmic drug products do not have to be tested for bacterial endotoxins, the FDA said, answering a second question about whether it is acceptable to omit bacterial test limits for these products. However, endotoxin testing may be required if the product is to be used on an abraded eye or used during surgery.

The FDA has advised industry to consider these matters before submitting controlled correspondence on these topics. The agency intends to add additional questions and answers as needed to address any frequently asked questions that may arise.

FDA Guidelines on Controlled Correspondence

© 2022 Society of Regulatory Affairs Professionals.

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Medical products

Operations | Medtech | Pharmaceutical and medical products

by Joan J. Dean on

We offer a suite of proprietary tools and methodologies to optimize technical systems, develop management infrastructures and promote good behavior and mentality. Here are examples of some of these tools we use to complement our work:

Comparative analysis of medical devicesMT: Diagnostic and transformation tool for manufacturing, supply chain, quality, purchasing and organization, with over 50 customizable metrics per module that give insightful recommendations for actionable opportunities.

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Suite of complexity management solutions: A diagnostic suite using advanced analytics to assess the complexity of a medical technology firm’s portfolio and the in-game value of optimizing and improving management, and provide actionable recommendations. It includes tools like Complexity Fingerprint, Wallet X-ray, Complexity Cost Calculator, Wallet Setup, and Complexity Cockpit.

Design to Value (DtV) and Cleansheet Solution ™ Laboratories: Our engineering centers of expertise where competitive product teardowns and cost modeling are performed to strengthen customer focus and help reduce time to market and product costs. Our Cleansheet Solution ™ helps establish cost transparency, analyze cost drivers, calculate target cost and reap those benefits. Learn more about Design to Value and Cleansheet Solution.

Purchasing centers: Our global sourcing centers located in Brazil, China, Eastern Europe, India and Mexico using our Global Sourcing Information Exchange (GSIE) database help identify suppliers in low cost countries. Learn about innovation, design and development, productivity, agility and automation, and quality, compliance and remediation.

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Generic drugs

The generic drug market is witnessing the emergence of Amgen Inc. and Dr. Reddys Laboratories Ltd. as major market contributors | 17000 + Technavio

by Joan J. Dean on


Understand the driving forces of the Generic Drugs market and target potential customers here.

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Technavio analysts curated the reports thoroughly through qualitative and quantitative research methodologies to yield the most relevant industry and business results.

Businesses around the world are focused on creating a resilient business model in the face of COVID-19. Suppliers are continuing their ongoing operations while building resilient business models as the path to recovery from the pandemic is being charted.

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Analysis of the main players in the market

  • Amgen Inc. – The company offers a wide range of generic drugs like Aimovig, Corlanor, Epogen, Xgeva and others.
  • Dr.Reddys Laboratories Ltd. – The company offers affordable generic formulations such as Omez (Omeprazole), Nise (Nimesulide), Ketorol (Ketorolac Thromethamine) and others
  • Fresenius SE and Co. KGaA – The company offers generic drugs for areas such as anesthesia, maldigestion and oncology

If you purchase an updated report within the next 60 days, we’ll send you the new edition and data extract FREE! Get a preview of the report here to get a detailed market share analysis of market players during the COVID-19 lockdown:

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Generic Drugs Market 2021-2025: Segmentation

The generic drugs market is segmented as follows:

  • Type
    • Small Molecule Generics
    • Biosimilars
  • Geography
    • North America
    • Europe
    • Asia
    • LINE


The generic drug market is driven by increased outsourcing of drug discovery and development and increasing drug patent expirations. Additionally, other factors such as the advent of RPA, increase in mergers and acquisitions, and hospital-owned generics are expected to drive the generic drugs market.

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Generic drugs

Online pharmacies could save Medicare billions on generic drugs

by Joan J. Dean on

PThe public outcry over the shockingly high cost of brand name drugs and the demand for new laws to limit the cost of these drugs has persisted for years. But more than 90% of all prescriptions – nearly 4 billion a year – are filled with generic drugs.

Little attention has been paid to the fees charged by insurance companies, drug benefit managers, and pharmacies to fill these generic prescriptions. Yet the difference between the highest and lowest price charged for the same generic drug is so great that billions of dollars could be saved each year by having prescriptions filled at the cheapest pharmacies.

The entry of companies like Amazon and GoodRx into the prescription fulfillment business is a game-changer. They offer prices far below what the federal government pays to insurance plans to have these prescriptions filled under Medicare Part D drug coverage. The repeal of the current design of Part D benefits and replacing it with a system in which the government directly reimburses low-cost pharmacies for filling generic prescriptions would save an estimated $18 billion a year. Patients would save an additional $8 billion in co-payments because the prices charged by these pharmacies do not require any form of insurance or additional co-payments.

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I compiled information from the Medicare Part D website on the amount spent per pill for the top 20 selling generic drugs of 2019. I then determined how much Amazon and GoodRx charged for a 90 day prescription for the same 20 medications and calculated the cost per pill for these prescriptions. For example, Medicare paid 26 cents per pill for atorvastatin, the generic version of the cholesterol-lowering drug Lipitor. Amazon fills a 90-day prescription for a 20-milligram atorvastatin tablet, the most common dose, for $4.20. This equates to less than 5 cents per pill. The government paid $919 million to insurance plans to distribute 3.6 billion atorvastatin tablets in 2019. Amazon reportedly distributed these tablets for $182 million, a savings of $737 million on a single drug generic.

As the chart here shows, Medicare spent $8.8 billion to distribute these 20 generic drugs in 2019. Amazon reportedly did this for just $4.6 billion and GoodRx for $5.1 billion. If the prescriptions had been filled by selecting the cheapest drug from Amazon or GoodRx, the cost would have been $3.5 billion. This represents a savings of $5.3 billion (60%) over what Medicare spent.

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In 2019, Medicare Part D filled approximately 1.2 billion generic prescriptions at a total cost of approximately $30 billion. If the 60% savings applied to all generic drugs dispensed under Part D, the government would have saved $18 billion.

In addition to overburdening the government, Part D insurance plans also charge patients co-payments for most generic prescriptions. Iqvia reports that 65% ($8 billion) of the $12 billion in Part D outlays paid by patients are for generic prescriptions. GoodRx estimates that its total price for filling generic prescriptions is less than the Medicare Part D copay about one-third of the time. The Amazon and GoodRx price is the total price of the drug. There is no quota. That means patients would save $8 billion in out-of-pocket costs, bringing the total savings from a Medicare drug benefit overhaul to $26 billion.

How is it possible that the cost of filling generic prescriptions can vary so widely? The answer lies in a lack of transparency on the true cost of generic drugs. The World Health Organization estimates that generic versions of essential medicines can be produced cost-effectively with a 99% reduction in the cost of the brand name medicine. Thus, a patented pill that sells for $1 can be produced profitably and sold as a generic for a penny. In fact, generic manufacturers now sell many of the most widely prescribed generic drugs in the United States for 1 cent to 5 cents per pill.

Competition among generic manufacturers ensures that these pills are offered for sale at a small profit compared to the actual cost of producing them. Yet in a few cases where such competition is lacking, as was the case with the generic version of the EpiPen, the cost of a generic drug may sell for only a small discount to the brand name product.

Insurance plans and drug benefit managers price their generic prescriptions at levels that the market will bear rather than at a reasonable markup over the actual cost of acquiring and dispensing the prescription. Patients and payers think they’re getting a good deal when they get a 70% discount and pay 30 cents per pill for the generic version of a brand name drug they used to pay $1 for. They have no idea that the pharmacy bought this pill for just a penny or two and markup each pill 10 to 20 times its cost. The high markup imposed by insurance plans and drug benefit managers is why the government pays 26 cents a pill for atorvastatin while Amazon sells it for 5 cents.

Discount pharmacies like Amazon disrupt the prescription drug market by pricing their prescriptions on a cost-plus basis while making a fair profit. A 90-day prescription for a generic drug acquired at a cost of 1 cent per pill has an ingredient cost of 90 cents. Average dispensing cost – the cost to the pharmacy for time spent counting and packaging pills, labeling pills, complying with prescription record keeping laws, and recording information required for reimbursement insurance plans – is about $2.40 per prescription. If a discount pharmacy charges $5.00 for this 90-day prescription, they will make a profit of $1.70 on the actual $3.30 cost of the prescription. This equates to a gross profit of 34%, which compares favorably to the reported profit margins of independent pharmacies.

For a 90 day prescription, adding ten cents to the cost of each pill would add $9 to the cost of the prescription. That doesn’t sound like a lot, but doing this for 4 billion prescriptions translates to $36 billion.

Medicare should be able to fill generic prescriptions at the lowest price charged for those prescriptions in the competitive retail market. But the 2003 law that created Part D prohibits the government from seeking the best price and gives private insurance plans exclusive power to set the price. The Republican administration that championed the enactment of Part D mistakenly believed that competition among insurance plans would result in the lowest prices and the widest choices for beneficiaries. No such competition ever materialized. Instead, Part D has created windfall profits for private insurance plans and drug benefit managers while adding unnecessary complexity to the generic prescription filling process. Patients are now faced with an incomprehensible array of forms, quantity limitations and co-payments that often make it cheaper to pay for a generic drug outright than to use Part D insurance.

The current design of the Part D advantage is ill-suited to a world in which discount pharmacies fill prescriptions for generic drugs at affordable prices without insurance. A new design that cuts out costly middlemen and relies on price competition between pharmacies will not only dramatically reduce Part D costs, but will also force all pharmacies to cut their profit margins if they hope to compete for prescriptions of part D, which represent 30% of retail pharmacy activity.

Part D prices for generic drugs would quickly become the benchmark for private payers and drive down prices and copayments for generic drug prescriptions in private insurance plans. The end result would be that more than 90% of all prescriptions could be filled at a lower cost to payers without imposing significant additional costs on patients.

Senate Democrats are currently negotiating a $3.5 trillion soft infrastructure package that will include legislation to reduce patient out-of-pocket payments in Part D and expand Medicare to cover vision, dental and hearing services by mandating new taxes. My proposal to reduce the cost of Medicare for the distribution of generic drugs and the Biden administration’s proposal to limit price increases for brand name drugs could produce enough savings on the cost of current Medicare benefits for drugs on prescription to pay for the proposed expansion of Medicare benefits without these taxes.

Given growing resistance from moderate Democrats to the $3.5 trillion price tag of the proposed infrastructure package, paying for new benefits by reducing the cost of existing ones may be the wisest course.

Alfred Engelberg is a retired intellectual property lawyer and philanthropist who focuses on efforts to make health care and medicine more affordable. As legal counsel to the generic drug industry, he played a major role in drafting the Hatch-Waxman Act of 1984, which created the modern generic drug industry.

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Medical products

PRIMED Medical Products donates over 1.5 million Level 3 surgical masks to Lao PDR to continue the global fight against COVID-19

by Joan J. Dean on

Edmonton, Alberta–(Newsfile Corp. – Sept. 8, 2021) – In a ceremony on Aug. 18, Lao PDR received a shipment of 1,592,500 ASTM Level 3 surgical masks donated by PRIMED Medical Products, in partnership with the Government of Canada in Laos. This shipment of masks was handed over to the government of the Lao PDR during a ceremony attended by the Minister of Health, Dr. Bounphaeng Phoummalaisit, Mr. Bob Paquin, Charge d’Affaires and Head of Office, Office of the Canadian Embassy in Laos, Mr. Leo Xie, PRIMED Deputy General Manager for Asia Manufacturing, and Ms. Peng Jin and Ms. Yu Hsuan Pi of VITA Park at the Ministry of Health Headquarters in Vientiane.

The masks donated are the same highly protective masks that many of those working on the front lines of COVID-19 in Canada and around the world rely on. The masks will be used by healthcare providers as Laos faces its second wave of the pandemic. Throughout the COVID-19 pandemic, PRIMED has been focused and successful in ensuring a consistent and safe supply of PPE to all of its global partners.

“Canada is a nation that gives back when the world is in need,” said David Welsh, President and CEO of PRIMED Medical Products. “We felt it was imperative to do our part to help protect the local community members who have welcomed us with open arms as we expand our manufacturing facility in Laos.”

“PRIMED is a Canadian company with a strong commitment to corporate social responsibility, and is keen to support the Government of Laos’ campaign to promote quality investment,” said Bob Paquin, Chargé d’Affaires, Office of the Embassy of Canada in Laos.

PRIMED recently completed the construction of the first phase of its factory in Laos. The wholly-owned facility measures 95,000 square feet and, at full capacity, will employ more than 300 people. This donation brings PRIMED’s total surgical mask donations during the pandemic to nearly 40 million masks.

About PRIMED medical products

Founded in 1995, PRIMED Medical Products is a Canadian manufacturer of personal protective medical equipment. PRIMED’s manufacturing facilities are ISO certified and undergo regular audits by international regulatory and certification bodies. PRIMED’s high-quality medical products are used in virtually every hospital in Canada and in healthcare facilities in the United States, South America, Europe, Asia, South Africa, Australia and New Zealand. Zeeland. Their product offering covers medical, surgical, and infection control products, including protective apparel and wound care.

Media Contact:
Lindsey Taylor, Marketing Specialist
Email: [email protected]

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/95539

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Medical products

Baxter acquires Hillrom in $10.5 billion medical products deal

by Joan J. Dean on

DEERFIELD, Ill. (AP) — Medical products company Baxter International will acquire medical technology company Hillrom for $10.5 billion in cash, the companies announced Thursday. Baxter will also absorb Hillrom’s debt and cash, bringing the total value of the deal to $12.4 billion.

Baxter will pay Hillrom shareholders $156 per share, a 26% premium to its closing price on July 27, when speculation of a deal began to spread. Hillrom shares closed at $145.06 on Thursday and rose more than 3% in premarket trading to $149.75.

Deerfield, Ill.-based Baxter, which offers essential hospital products including dialysis, IV fluids and other therapies and devices, had 2020 revenue of $11.7 billion, with projected sales of $12.6 billion this year.

Hillrom, headquartered in Chicago, focuses on medical technology products and services such as smart beds, patient monitoring and diagnostic technologies, and advanced surgical equipment. Its turnover is close to 3 billion dollars per year.

The deal has been agreed by the boards of both companies and is expected to close in early 2022, pending regulatory approval and a vote from Hillrom shareholders.

Baxter shares rose about 1% in premarket trading to $78.40.

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Medical products

Baxter to Acquire Hillrom in $ 10.5 Billion Medicines Deal | Illinois News

by Joan J. Dean on

DEERFIELD, Ill. (AP) – Medicines company Baxter International will acquire medical technology company Hillrom for $ 10.5 billion in cash, the companies said Thursday. Baxter will also absorb Hillrom’s debt and cash, bringing the total value of the transaction to $ 12.4 billion.

Baxter will pay Hillrom shareholders $ 156 per share a 26% premium over its July 27 closing price when speculation about a deal began to rise. Hillrom shares closed at $ 145.06 on Thursday and rose more than 3% in pre-market trading, to $ 149.75.

Baxter, based in Deerfield, Ill., Which offers essential hospital products including dialysis, intravenous fluids and other therapies and devices, had sales of $ 11.7 billion in 2020, with expected sales of $ 12.6 billion this year.

Hillrom, headquartered in Chicago, focuses on medical technology products and services such as smart beds, patient monitoring and diagnostic technologies, and advanced surgical equipment. Its turnover is approaching $ 3 billion per year.

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The deal was reached by the boards of directors of both companies and is expected to be finalized in early 2022, pending regulatory approval and a vote by Hillrom shareholders.

Baxter shares rose about 1% in pre-market trading, to $ 78.40.

Copyright 2021 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Generic drugs

The size of the global generic drugs market worth USD 442.3 billion by 2026, according to market data forecast

by Joan J. Dean on

Global Generic Drugs Market Size and CAGR (2021 to 2026)

According to our report, the global generic drugs market size was valued at USD 311.8 billion for 2021 and is projected to reach USD 442.3 billion by the end of 2026, growing at 7.24% CAGR during the forecast period.

Impact of COVID-19 on the global generic drugs market:

Generic and biosimilar drug companies are working tirelessly to ensure patients have access to the medicines they need as the COVID-19 outbreak progresses. Despite the global pharmaceutical supply chain under unprecedented stress and demand, producers of nine out of ten prescriptions filled with generics are driving demand for generics. The COVID-19 pandemic has hampered drug development in a variety of ways, including disrupting ingredient supply and delaying inspections of manufacturing facilities. As a result, during COVID-19, the United States Food and Drug Administration (FDA) issued guidance on generic drug development and the filing of abbreviated new drug applications (ANDAs), which outline how manufacturers can face the challenges of the pandemic. Additionally, the companies have come together under the not-for-profit Medicines Patent Pool (MPP). A group of 18 generic drug makers from India, China, Bangladesh and South Africa have pledged to work together to accelerate access to millions of doses of new COVID-19 treatments for low-income countries and intermediate. Nevertheless, questions regarding equity, overflow capacity, the social security system, data collection and drug supply, especially for generic drugs, have been raised by COVID-19. The majority of active pharmaceutical ingredients (APIs) are imported from other countries. For example, 80% of APIs used in drugs supplied to the United States come from China and India. Additionally, companies often employ a single plant to manufacture all of their supply, disrupting generic drug manufacturing.

Browse Report Details @ https://www.marketdataforecast.com/market-reports/global-generic-drugs-market

KEY DRIVERS:

The growing prevalence of chronic diseases is fueling the demand for generic drugs.

The demand for generic drugs is increasing as chronic diseases become more prevalent. Furthermore, disease prevention is highly dependent on generic drugs. There has been a significant increase in the use of generic drugs for over three decades, and they account for 83% of all prescriptions filled. For chronic diseases such as diabetes, hypertension, osteoporosis, depression and anxiety, the study published in PLOS Medicine showed that more than 3.5 million people found equivalent clinical results in patients who started generics and branded drugs. For this reason, the use of generic drugs has increased, which has fueled the expansion of the generic drug market.

The expiration of patents on branded drugs is further fueling the generic drug market.

A generic drug is designed to be identical to an approved brand name drug in terms of dosage form, potency, method of administration, quality, and performance. Generic drugs are interchangeable with brand name drugs. When a brand name drug’s patent expires, the producer attempts to produce a generic drug. Several of its patents will expire in October 2021, possibly allowing generic copies to enter the market. Xgeva and Prolia from Amgen, Faslodex from AstraZeneca, Eraxis from Pfizer, Factive from LG Chem, Angeliq from Bayer and Bredinin from Chong Kun Dang are among the patents that will expire in January 2021. About 62 patents for more than 150 pharmaceutical products in South Korea will expire this year. , more than half of which are expected to be generics if no new patents are added to the patent list. As a result, the generic drug market is growing.

RESTRAINT FACTORS:

Market expansion is hampered by public perception of generic drugs. Because generics are inexpensive, they are considered substandard. In general, the notion that low price equals poor quality is widely held. Additionally, strict rules governing the safety and efficacy of generic drugs are hampering market expansion.

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KEY MARKET OVERVIEW:

  • According to gender, the generic drugs market is segmented into pure generic and branded drugs.
  • Depending on the application, the cardiovascular segment dominated the generic drug market in 2020 and accounted for a large market share in 2020. Rising cases of heart failure, hypertension, and stroke are driving the demand.
  • The North American region is a fast growing market for generic drugs. This is because, in the US region, most prescriptions are filled with generic drugs.
  • Major players in the generic drugs market are Mylan Inc., Sun Pharmaceutical Industries Ltd., Cipla Inc., Inc., Pfizer Inc., Teva Pharmaceutical Industries Ltd., Lupine Ltd., Sanofi and others. Additionally, these players are involved in strategic activities, such as collaborations, new product launches, technological advancements, and acquisitions.

The report can be customized as needed; talk to our analyst team @ https://www.marketdataforecast.com/market-reports/global-generic-drugs-market/customization

Recent market developments:

  • In March 2021, Libbs Farmaceutica and Biocon teamed up to bring generic drugs to Brazil, the sixth most populous country in the world.
  • In March 2021, to improve its R&D engine and expand its generics and CDMO business, ANI Pharmaceuticals, Inc. purchased Novitium Pharma.
  • In January 2020, with the help of Civica Rx and 18 independent BCBS companies, the Blue Cross Blue Shield Association and BCBS companies were working together to reduce the cost of generic prescription drugs.

SEGMENTS COVERED IN THIS REPORT:

By type:

  • Pure generic drugs
  • Branded generic drugs

Per application:

  • The central nervous system (CNS)
  • Cardiovascular
  • Dermatology
  • Oncology
  • Respiratory
  • Others

By region:

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

KEY MARKET LEADERS FEATURED IN THIS REPORT:

  1. Ranbaxy Laboratories, Ltd
  2. Actavis
  3. Mylan, Inc.
  4. industries, ltd.
  5. Reddy Laboratories
  6. By Pharmaceutical, Inc.
  7. Sandoz International GmbH
  8. Hospira, Inc.
  9. Apotex, Inc.
  10. Watson Pharmaceuticals, Ltd.
  11. Teva pharmaceutical

BROWSE REGIONAL REPORTS:

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Generic drugs

OP-ED: Americans deserve public generic drugs – Orange Leader

by Joan J. Dean on

Bold policies could have saved America’s largest generic drug factory, but it’s never too late to start putting communities first.

It’s an all-too-familiar story. A company with some of the highest paying jobs and a vital community anchor decides to engage in “restructuring” to “maximize long-term value creation”.

In other words, it closes its doors and lays off its workers in search of bigger profits.

But the late July closure of the Viatris pharmaceutical plant in Morgantown, West Virginia – which employed nearly 1,500 people and was the largest remaining generic pharmaceutical plant in the United States – is particularly infuriating.

West Virginia Governor Jim Justice echoed a sentiment across the political spectrum when he said Aug. 4, “I think it’s pitiful, pitiful, absolutely pitiful that our federal government right now, with something as critical as pharmaceuticals are to our citizens, either just decide to sit on the sidelines and let this disaster happen.

The shutdown was only preventable – if there had been federal or state action based on prioritizing protecting public health and economic well-being over short-term shareholder returns. We had the tools. All that was needed was the audacity and the political will to use them.

The chain of events began in 2020 when factory owner Mylan (led by Heather Bresch, daughter of West Virginia Senator Joe Manchin) merged with Upjohn to form a new company, Viatris, creating the largest generics company in the world. Shortly after, Viatris announced a “restructuring initiative” which included closing some of its plants, including the Morgantown plant.

The local Steelworkers representing many workers at the plant began calling on both the new Biden administration and state officials to keep the plant open. Their key argument was its role in the country’s pharmaceutical supply chain, especially in the context of the COVID-19 pandemic. The plant produced 18 billion doses of low-cost generics a year, including many essential drugs paid for through various federal programs.

A letter to the Biden administration signed by the Steelworkers and about 40 other healthcare and advocacy groups (including The Democracy Collaborative, where I work) called for using the Defense Production Act to stop the plant shutdown .

One of President Biden’s first executive orders called for using the law if necessary to “acquire additional inventory, improve distribution systems, build market capacity, or expand the industrial base.” But the Biden administration, like the Trump administration before it, did none of that in Morgantown.

Keeping the Morgantown plant open would have been a clear case of ensuring local distribution and manufacturing capacity for a critical good: medicine. The designation the plant has already received from the Department of Homeland Security as critical infrastructure underscores this.

The opportunity to explore a public ownership option in pharmaceuticals has been overlooked. Public enterprises are free from profit constraints and can instead define their bottom line by what they contribute to public health, scientific advancement, and local economic resilience.

The payoffs for our communities would be enormous: Reliable access to affordable generics helps keep people out of hospitals and into jobs, schools and community service roles. Generics significantly reduce our overall health care costs. Additionally, manufacturing plants are vital economic engines as well as centers of local intellectual capital.

It is encouraging that a public institution, West Virginia University, announced talks with Viatris to acquire the plant, but that was after hundreds of highly skilled workers were unnecessarily laid off, most of whom are eager to see if an agreement is reached before looking for New work.

What we really need in the face of continued outsourcing and offshoring is a genuine industrial strategy that includes public ownership and puts community health above the demands of absentee shareholders.

Dana Brown is director of the Next System Project of The Democracy Collaborative, “a research and development laboratory for the democratic economy”. This editorial was distributed by OtherWords.org.

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Medical products

Advancing next-generation medical products

by Joan J. Dean on
Photos courtesy of Avient Corporation, © 2021

An aging population and the growing threat of emerging infectious viral diseases, such as COVID-19, mean that global healthcare is an extremely important problem and is changing dramatically and dynamically. To respond to these changes, a new generation of specialized and sustainable medical equipment solutions is emerging. Read on to learn more about the evolution of this industry and to explore an example of medical device innovation.

If you haven’t seen a doctor in person since the onset of the coronavirus pandemic, you are not alone. Telemedicine and on-demand care have exploded over the past 12 months and are two of many growing trends in global healthcare. Another trend in the era of increasing personalized medicine is the development of biologic pharmaceuticals. A rapidly growing market, the revenues of biologic pharmaceutical companies have increased by 70% over the past five years, to more than US $ 232 billion.[i]. Yet the high doses required by patients for biologic therapies can present very real challenges for drug delivery.[ii]. Whatever the trend and in all directions in which healthcare develops, the goal is always to protect and improve the lives of patients.

Plastics in medical devices and pharmaceutical packaging increasingly play a vital role in providing safe treatments and their use is expected to increase further. This can be attributed to the fact that they offer design freedom, protection, convenience and functionality that few other materials can match. Globally in 2020, approximately 7.6 million tonnes of plastics were used in healthcare applications[iii] and this is expected to grow by around 8.6% from 2020 to 2027. Companies supplying plastics to the healthcare market must have in-depth knowledge of the industry, as well as advanced technical and design capabilities, to develop innovative solutions that truly respond to their customers. challenges.

Let’s take a look at an example of an innovative solution – a conceptual auto-injector, where the new generation meets industry trends for the functionality and aesthetics of surfaces.

Auto-injectors are a great example of innovation, bringing more convenience and control to the lives of patients. Playing on trends in telemedicine, on-demand care and biologics, they offer self-management and drug administration, technology-driven monitoring and diagnostics, as well as the ability to deliver increased volumes of drugs. and large molecule biologics.

This study example describes a conceptual auto-injector developed by Avient – a new materials company born from two historical leaders, PolyOne and Clariant Masterbatch. It will illustrate how Avient has used innovative materials, design and technological services to accelerate the development of next generation products.

Photos courtesy of Avient Corporation, © 2021

The injection window and cap of an autoinjector require excellent clarity, scratch resistance, and exceptional toughness for visualizing drug levels. In this study, an anti-UV additive was used to protect the drug contents from harmful UV rays without sacrificing clarity or transparency. Next, a dynamic masterbatch formulation (MEVOPUR ™ medical grade dyes) was used to enable product differentiation, better drug identification and consistent branding. MEVOPUR colors highlight the cap, button, lot ID / SKU, trigger and plunger. The raw materials were tested against common pharmaceutical standards to ensure that the devices would be safe and compliant from a regulatory point of view.

On the body of the autoinjector, a laser marking additive has been used to enable inkless marking, with no surface pretreatment required, thus avoiding solvent residue. The additive provided reliability and process improvement over traditional marking technologies and improved design possibilities due to the absence of physical contact with the marking system. This type of laser marking functionality can be combined with other functions or dyes to meet performance and aesthetic needs. In addition, to combat the increase in counterfeit drugs and devices in the healthcare industry, Avient has also developed a comprehensive plastic solution that protects against counterfeiting, while enabling medical device companies to ensure the integrity. supply chain with low impact on productivity and operations.

For the integrated rigid needle guard and device cap, biocompatibility, durability and overmolding are essential. A medical grade TPE (Versaflex ™ HC TPE) replaced rubber, with sealing properties to prevent needle contamination and oxygen contact with drugs in pre-filled syringes. These TPEs are USP VI tested and chemical resistant with low extractability and no tearing.

The viscosity of the drug has a direct impact on the pain of patients during drug administration. Therefore, the device’s heating system and heat exchanger used thermally conductive formulations to help heat and reduce the viscosity of biologic drugs.

Technology is transforming the way care is delivered by making it simpler, easier, more collaborative and more data-driven. This conceptual auto-injector is a demonstration of how next-generation materials and design expertise can truly improve a finished device.

If you would like more information on this application study, or on Avient materials and colorant / additive technologies, please visit avient-help.com.

[i] https://www.iqvia.com/-/media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next
_phase_des_biologics.pdf
[ii] https://pubmed.ncbi.nlm.nih.gov/26277263/
[iii] https://www.grandviewresearch.com/industry-analysis/medical-plastics-market

Content sponsored by Avient Corporation

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Generic drugs

Consumer perception fuels brand wars and affects use of generic drugs, says CCI chief

by Joan J. Dean on

New Delhi: According to Ashok Kumar Gupta, Chairman of the Competition Commission of India (CCI), consumer perception of variation in efficacy is driving a brand war in the pharmaceutical retail market, diluting the chilling effect on the prices of drugs sold under their chemical or generic names.

Gupta highlighted the role that generic drugs can play in creating the competitive pressures needed to lower prescription drug prices, reduce health care costs and improve access. However, Indian consumers are ostensibly paying a premium for brands, Gupta said at a CCI-hosted workshop on Friday on competition issues in the pharmaceutical sector. His comments were based on an interim market study conducted by the regulator.

The pharmaceutical market is different from other markets as consumers often do not deviate from the brand prescribed by the doctor or opt for the same drug sold under its chemical name. This distorts competition in the market. Also, drug manufacturers market their products through physicians rather than directly to consumers.

In India, generic drugs promoted by companies under their brand names are called branded generics and those sold under their chemical name are called “generic generics”, although both categories are off-patent drugs.

On this issue of the prevalence of branded generics in the pharmaceutical retail market in India, Gupta highlighted the key role that quality expectations and the perception of efficacy variation between drugs play in fueling brand competition. and dilute the generic price reduction effect in India. India, said an official statement after the workshop. Apart from the quality aspect, he alluded to the important role that Janaushadhi and the emerging private generic retail chains in the country can play in increasing the availability and improving the uptake of generic generics, says the statement quoting Gupta.

Vinod K. Paul, member of NITI Aayog, who spoke on the occasion, said that access to medicines without financial hardship and quality assurance were essential for universal health coverage.

Considering that expenditure on drugs accounts for 70% of out-of-pocket healthcare expenditure in India, he stressed the importance of improving accessibility of drugs, according to the statement.

Paul pointed out that streamlining the commercial margins of 42 cancer drugs on a pilot basis in 2019 led to cost savings of ₹984 crores for over 500 brands across 42 formulations. Paul further cited instances where margin rationalization resulted in a 90% price reduction on certain drugs, according to the release.

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Generic drugs

Reviews | Public generic drugs are the answer

by Joan J. Dean on

It’s an all-too-familiar story. A company with some of the highest paying jobs and a vital community anchor decides to engage in “restructuring” to “maximize long-term value creation”.

In other words, it closes its doors and lays off its workers in search of bigger profits.

But the late July closure of the Viatris pharmaceutical plant in Morgantown, West Virginia — which employed nearly 1,500 people and was the largest remaining generic pharmaceutical plant in the United States — is particularly infuriating.

West Virginia Governor Jim Justice echoed a sentiment across the political spectrum when he said Aug. 4, “I think it’s pitiful, pitiful, absolutely pitiful that our federal government right now, with something as critical as pharmaceuticals are to our citizens, either just deciding to sit on the sidelines and let this disaster happen.”

The shutdown was only preventable — had there been federal or state action based on prioritizing protecting public health and economic well-being over short-term shareholder returns. We had the tools. All that was needed was the audacity and the political will to use them.

The chain of events began in 2020 when factory owner Mylan (led by Heather Bresch, daughter of West Virginia Senator Joe Manchin) merged with Upjohn to form a new company, Viatris, creating the largest generics company in the world. Shortly after, Viatris announced a “restructuring initiative” which included closing some of its plants, including the Morgantown plant.

The local Steelworkers representing many workers at the plant began calling on both the new Biden administration and state officials to keep the plant open. Their key argument was its role in the country’s pharmaceutical supply chain, especially in the context of the COVID-19 pandemic. The plant produced 18 billion doses of low-cost generics a year, including many essential drugs paid for through various federal programs.

A letter to the Biden administration signed by the Steelworkers and about 40 other healthcare and advocacy groups (including The Democracy Collaborative, where I work) called for using the Defense Production Act to stop the plant shutdown .

One of President Biden’s first executive orders called for using the law if necessary to “acquire additional inventory, improve distribution systems, build market capacity, or expand the industrial base.” But the Biden administration, like the Trump administration before it, did none of that in Morgantown.

Keeping the Morgantown plant open would have been a clear case of ensuring local distribution and manufacturing capacity for a critical good: medicine. The designation the plant has already received from the Department of Homeland Security as critical infrastructure underscores this.

The opportunity to explore a public ownership option in pharmaceuticals has been overlooked. Public enterprises are free from profit constraints and can instead define their bottom line by what they contribute to public health, scientific advancement, and local economic resilience.

The payoffs for our communities would be enormous: Reliable access to affordable generics helps keep people out of hospitals and into jobs, schools and community service roles. Generics significantly reduce our overall health care costs. Additionally, manufacturing plants are vital economic engines as well as centers of local intellectual capital.

It is encouraging that a public institution, West Virginia University, announced talks with Viatris to acquire the plant, but that was after hundreds of highly skilled workers were unnecessarily laid off, most of whom are eager to see if an agreement is reached before looking for New work.

What we really need in the face of continued outsourcing and offshoring is a genuine industrial strategy that includes public ownership and puts community health above the demands of absentee shareholders.

read more
Medical products

Jeremy Perkins, CEO of Precision Medical Products, named one of the top 50 CEOs in healthcare technology in 2021

by Joan J. Dean on

ROCKLIN, Calif., August 24, 2021 / PRNewswire / – CEO of Precision Medical Jeremy Perkins was named one of The Healthcare Technology Report’s Top 50 CEOs in Health Technology. This recognition comes as Precision Medical Products continues to expand its hospital-to-home offerings, including the Circul8 Pro®, VenaOneMT, and PreVent® products.

Prior to launching Precision Medical Products in 2010, Perkins built a reputation for excellence in sales and marketing. After serving as District Sales Manager for Southwestern, managing over 60 sales representatives, Perkin’s launched his career in the medical products industry as Principal Territory Sales Manager for DonJoy Orthopedic.

“I am honored to be recognized among my industry peers and hope this will further inform the important work we do at Precision Medical Products. We continue to pursue our goal of becoming the largest DVT prevention company in the country and are dedicated to our mission of preventing postoperative blood clots through our innovative products, ”shared Perkins.

Deep vein thrombosis (DVT) is one of the leading causes of preventable hospital death, and the industry has traditionally lacked the appropriate technology to assess, prevent, and detect patients most at risk of developing DVT.

With its suite of DVT devices and technologies, Precision Medical is driving the future of DVT prevention, working towards sensor technology capable of identifying, transmitting, tracking and analyzing physiological data for use in a clinical analysis framework. Precision Medical’s products will advance the industry in the detection and prevention of blood clots in a mobile home solution, further strengthening the company’s home hospital initiative.

About precision medical products: Since launching as a self-funded startup in 2010, Precision Medical Products has been helping patients recover from surgery, using its innovative DVT prevention products, programs and offerings. Precision Medical Products was recognized on Inc. 5000’s list of America’s fastest growing companies and received a variety of innovation awards for its patented products.

SOURCE Precision Medical Products

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Generic drugs

FDA updates bioequivalence guidelines for generic drugs

by Joan J. Dean on

Posted on August 20, 2021 | By Kari Oakes

Generic drug makers received updated draft guidance from the U.S. Food and Drug Administration on Friday; the guidelines update some recommendations on the conduct of bioequivalence (BE) studies that have pharmacokinetic endpoints.

Announcing the availability of the updated draft guidance, the FDA said the document is intended to “clarify the agency’s recommendations regarding BE information submitted in a [abbreviated new drug application] submission, provide assistance to potential ANDA applicants, and support patient access to high-quality, low-cost medicines. The new revision updated a draft originally published in December 2013. (RELATED: FDA Updates Bioequivalence Testing Guidance for Generic Drug Manufacturers, Regulatory Focus December 04, 2013)

Applicants considering submitting an abbreviated new drug application (ANDA) should also consult the product-specific guidance for detailed information on BE studies to be performed as part of the submission process, the FDA noted.

The revised draft is rearranged so that some material that was originally in an attachment is now in the main body of the guide, while other material has been moved to one of two appendices. The first annex largely reproduces the content of an attachment to the first draft and provides general guidelines for the conduct of the study.

The second appendix is ​​new; it provides a step-by-step guide for using a reference-scale mean BE approach in the statistical analysis of BE for highly variable drugs.

Revisions to the 2013 draft specify that ANDA applicants must submit the results of all BE studies conducted on a drug substance that has the same formulation as the proposed drug product. The revised guidelines also clarify situations in which a repeat crossover study design might be appropriate.

The study population selection document guidelines now include a detailed explanation of how a BE assessment in adults can be used to support BE assessment in pediatric populations, noting that a rationale for accompanying must “include information demonstrating that the inactive ingredients in the proposed products are appropriate for use in the pediatric population.

Additional information is also included on the calculation of the extent of exposure for single dose studies, and revisions have also been made to the recommendations for the calculation of partial exposure. The revised draft guidance provides additional considerations for when a fed BE study should be conducted in addition to a fasted BE study, and for conducting sparge BE studies.

The revised draft also includes additional considerations for BE testing for delayed-release products and clarifies the conditions under which additional concentrations of modified-release products are considered to have bioequivalence. More details regarding other delivery methods such as orally disintegrating tablets, sublingual tablets and transdermal delivery are also included in the updated draft guidance.

The section on in vitro the dissolution tests include references to additional guidelines published after the 2013 publication date of the original version.

“The FDA is issuing this revised draft guidance to seek public comment on the topics addressed in the guidance,” the agency noted in its announcement.

FDA

© 2022 Society of Regulatory Affairs Professionals.

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Generic drugs

Global asthma drug markets of $23.6 billion, 2021-2026

by Joan J. Dean on

DUBLIN, August 19, 2021 /PRNewswire/ — The report “Global Asthma Drugs Market (2021-2026) by Drug, Jurisdiction, Source, Organization, Application, Geography, Competitive Analysis and Impact of Covid-19 with Ansoff Analysis” has been added to from ResearchAndMarkets.com offer.

The Global Asthma Drugs Market is estimated at $15.6 billion in 2021 and is expected to reach $23.6 billion by 2026 at a CAGR of 8.6%.

Market dynamics

Rising incidence of asthma and other respiratory syndromes is one of the prominent elements increasing the progress of the market. Another factor driving the expansion of the market is the increased awareness among the population about the accessibility of asthma treatments and the growth of combination remedies for the treatment of respiratory disorders.

Some of the other aspects driving the market are the development of medical sciences, cumulative healthcare expenditures, widespread research, and healthcare structure upgrades. However, the need for strict government oversight for asthma drug approval, drug patent termination, and drugs showing side effects is limiting the market growth.

Market segmentation

  • By drug, the market is categorized into quick-relief drugs, long-term controller drugs, and others. Among all, the long-term control medication segment is estimated to hold the highest market share during the forecast period.
  • By administration, the market is categorized into tablets and capsules, liquids, inhalers, injections, sprays, and powders. Among all, tablets and capsules segment is estimated to hold the highest market share during the forecast period.
  • By source, the market is categorized as environmental and generic. Among the two, the generic segment is estimated to hold the highest market share during the forecast period.
  • By organization, the market is categorized as private and public. Among the two, the public segment is estimated to hold the highest market share during the forecast period.
  • By application, the market is categorized as pediatric, adult, and adolescent. Among all, the adult segment is estimated to hold the highest market share during the forecast period.

RECENT DEVELOPMENTS

  • OMRON Healthcare launches wheeze detection device to prevent asthma attacks in children. – December 3, 2020
  • Teva Pharmaceutical Industries launches two digital inhalers for asthma patients. – September 22, 2020

Company Profiles

Some of the companies covered in this report are GlaxoSmithKline, Pfizer, Vectura Group, Boehringer Ingelheim, Roche, Novartis AG, Merck & Co Inc, etc.

Main topics covered:

1 Description of the report
1.1 Objectives of the study
1.2 Market definition
1.3 Currency
1.4 years considered
1.5 Language
1.6 Key shareholders

2 Research methodology
2.1 Research process
2.2 Data collection and validation
2.3 Market Size Estimation
2.4 Assumptions of the study
2.5 Limitations of the study

3 Executive Summary
3.1 Presentation
3.2 Market Size and Segmentation
3.3 Market Outlook

4 market influencers
4.1 Drivers
4.1.1 Growing prevalence of asthma
4.1.2 Increasing Asthma Drug Acceptance with FDA Approval
4.1.3 Government Initiatives Fuel Asthma Medication Awareness
4.2 Constraints
4.2.1 Expiration of Patented Medicines
4.2.2 High penetration of generic drugs
4.3 Opportunities
4.3.1 Technological Advancements in Asthma Drug Development
4.3.2 Introduction of generic drugs in developing regions
4.4 Challenges
4.4.1 Strict Government Regulations for Asthma Drug Approval
4.5 Trends

5 Market Analysis
5.1 Regulatory scenario
5.2 Porter’s Five Forces Analysis
5.3 Impact of COVID-19
5.4 Ansoff matrix analysis

6 Global Asthma Drugs Market, By Drug
6.1 Presentation
6.2 Quick-relief drugs
6.3 Long-term controller medications
6.4 Others

7 Global Asthma Drugs Market, By Jurisdiction
7.1 Presentation
7.2 Tablets and capsules
7.3 Liquids
7.4 Inhalers
7.5 Injections
7.6 Sprays and powders

8 Global Asthma Drugs Market, By Source
8.1 Presentation
8.2 Environment
8.3 Generic

9 Global Asthma Drugs Market, By Organization
9.1 Presentation
9.2 Private
9.3 Public

10 Global Asthma Drugs Market, By Application
10.1 Presentation
10.2 Pediatrics
10.3 Adults
10.4 Teenager

11 Global Asthma Drugs Market, By Geography

12 Competitive landscape
12.1 Competitive Quadrant
12.2 Market Share Analysis
12.3 Strategic Initiatives

13 company profiles

  • Aerocrine AB
  • AMIKO Digital Health
  • Astra Zeneca
  • BEXIMCO Pharmaceuticals
  • Boehringer Ingelheim
  • Chiesi Farmaceutici SpA
  • Cipla Inc.
  • GlaxoSmithKline,
  • H&T Presspart
  • Merck & Co Inc.
  • Mundipharma
  • Novartis AG
  • Omron Health
  • PARI Holding Medical
  • Pfizer
  • PNEUMA Respiratory
  • Roche Holding AG
  • Sunovion Pharmaceuticals
  • Teva Pharmaceutical Industries Ltd
  • Vectura Group

For more information about this report visit https://www.researchandmarkets.com/r/6l6hzx

Media Contact:
Research and Markets
Laura Woodsenior
[email protected]

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SOURCE Research and Markets

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Medical products

Dan Berish Joins Precision Medical Products as New President of Acute Care Division

by Joan J. Dean on

“Dan Berish’s the unique skill set is almost unparalleled in our industry, ”said Precision Medical CEO Jeremy Perkins. “With his extensive DVT and vascular experience in acute care and hospital settings and strong sales strategy skills, we believe Dan will continue to position Precision Medical as the premier hospital-based DVT medical device company in domicile in the country. “

While at Aircast and DJO, Berish was responsible for building the sales, clinical and implementation teams for vascular and DVT products, both domestic and international. He grew up Aircast from $ 9 million at $ 180 million before its acquisition by DJO. At Össur, Berish has helped form multiple sales partnerships with national clinics, CHWs and hospital systems.

“It’s a new chapter for me,” Berish said. “I really like the direction Precision Medical is taking. The acute care market is ripe for innovation and patient-centric devices, and Precision Medical is leading the way with the introduction of the first and only fully mobile acute care DVT device, VenaOne. I believe there is a bright future at Precision Medical and I am delighted to join the team. “

Berish will define the general direction, strategy development and sales execution of Precision Medical’s new Acute Care DVT division, focused on partnerships with hospitals and clinics.

About precision medical products: Since launching as a self-funded startup in 2010, Precision Medical Products has been helping patients recover from surgery, using its innovative DVT prevention products, programs and offerings. Precision Medical Products was recognized on Inc. 5000’s list of America’s fastest growing companies and received a variety of innovation awards for its patented products.

SOURCE Precision Medical Products

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Medical products

Precision Medical Products Completes Largest Acquisition Ever, Establishing Leader in Hospital-to-Home Continuum of Care

by Joan J. Dean on

ROCKLIN, Calif., August 18, 2021 /PRNewswire/ — With the acquisition of Innovamed Health and Vena Group, two of the premier companies in the mobile compression device industry, Precision Medical Products is leading the future of the industry and heralding its “cut the cord” campaign. This acquisition makes Precision Medical Products the nation’s largest and most protected mobile DVT (deep vein thrombosis) patentee.

“Our goal is to become the largest DVT prevention company in the country and today we are well on our way. In addition to our current line of products, this acquisition opens the door to a true continuum of care, from hospital to home. With our offerings, patients can truly ‘cut the cord’ and experience freedom of mobility during recovery,” said Precision Medical CEO Jeremy Perkins.

The acquisition is a huge boost for Precision Medical Products, which now owns VenaPro, the market’s first mobile single-use compression device, and VenaOne, the first portable compression device for the hospital market. Through this agreement, Precision Medical Products also acquired leading intellectual property from Innovamed and Vena Group, setting the stage for a monumental day in the company’s history.

Perkins concluded, “Precision and Innovamed have been competitors and friends for years, and we are excited to join forces to push the boundaries of DVT innovation even further.

Precision Medical Products’ existing line of offerings includes the CIRCUL8® brand, including the CIRCUL8® Pro, a powerful and portable on-the-go DVT prevention product and the VenaOne®, a mobile DVT prevention system for hospital use . Both are self-contained and wireless, allowing for maximum mobility.

About Precision Medical Products: Since launching as a self-funded startup in 2010, Precision Medical Products has been helping patients recover from surgery, using its innovative DVT prevention products, programs and offerings. Precision Medical Products has been recognized on the Inc. 5000 list of America’s fastest growing companies and has received a variety of innovation awards for its patented products.

SOURCE Precision Medical Products

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Medical products

PRIMED Medical Products makes hospital-grade PPE available to everyday consumers

by Joan J. Dean on

Face masks used in Canadian hospitals are now available online

Edmonton, Alberta–(Newsfile Corp. – Aug. 11, 2021) – PRIMED Medical Products, a leading manufacturer and supplier of medical personal protective equipment (PPE) in Canada, is making its products available to Canadian consumers. This week, the Edmonton-based company launched an e-commerce store with a selection of its products, including face masks made at its new Canadian manufacturing facility.

Throughout the COVID-19 pandemic, PRIMED has been focused and successful in ensuring a consistent and safe supply of PPE throughout the Canadian healthcare system. With the launch of their e-commerce platform, the general public will now have access to the product of choice for Canadian healthcare professionals.

The online store found at shop.primed.ca currently sells a range of products, all tested to strict international standards for quality and protection. Medical face mask options include adult and child masks as well as integrated visor and anti-fog options, all of which provide both comfort and protection for the wearer. The product options available online give Canadian consumers the ability to protect themselves and their families with the same products used daily in hospitals.

Founded in Edmonton, Alberta in 1995, PRIMED has been a leading player in the Canadian PPE market for years, bridging the gap between manufacturing high quality medical products and healthcare organizations across Canada. . In the fall of 2020, PRIMED opened its first manufacturing facility in Canada, in Cambridge, Ontario, to supply Canadian hospitals with a line of Canadian-made face masks.

PRIMED has a long standing reputation in the healthcare industry. The organization is highly respected for its consistently high quality and the positive work environment it maintains. In April 2021, the company was named one of Deloitte Canada’s “Best Managed Companies” for the fourth consecutive year, earning PRIMED a spot among the “Gold Standard Winners”.

PRIMED’s products can be purchased by consumers at shop.primed.ca.

About PRIMED medical products:

Founded in 1995, PRIMED Medical Products is a Canadian manufacturer of personal protective medical equipment. PRIMED’s manufacturing facilities are ISO certified and undergo regular audits by international regulatory and certification bodies. PRIMED’s high-quality medical products are used in virtually every hospital in Canada and in healthcare facilities in the United States, South America, Europe, Asia, South Africa, Australia and New Zealand. Zeeland. Their product offering covers medical, surgical, and infection control products, including protective apparel and wound care.

Media Contact:
Lindsey Taylor, Marketing Specialist
Email: [email protected]

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/92782

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Medical products

IZI Medical Products Announces the Launch of Vertefix® HV Cement with Insite™ Tracking Beads

by Joan J. Dean on

OWINGS MILLS, Md., August 2, 2021 /PRNewswire/ — IZI Medical Products, LLC (“IZI”), a leading manufacturer of interventional radiology devices and products for the treatment of vertebral compression fractures, announces the official launch of Vertefix HV Cement (” Vertefix HV”). Vertefix HV provides a unique solution that addresses the need for real-time flow visualization during cement injection for vertebroplasty and kyphoplasty procedures.

“Our goal in developing Vertefix HV was to give doctors a better way to track and control where cement is flowing during their procedures,” said Greg GroenkeCEO, IZI Medical. “The introduction of high-viscosity variable-size barium particles makes this possible, improving patient outcomes and safety.”

“Vertefix HV will help you control your cement and allow you to have excellent cement viscosity immediately after mixing. It has optimum volume of cement with good working time and viscosity, as well as excellent visualization for so you can see when the cement is flowing and where it’s going Insite beads are a great addition and now new to all cements on the market Ultimately this is the best cement I’ve used since I remember,” said Dr. Douglas BeallHead of Services and Interventional Spine Services, Comprehensive Specialty Care, Edmund, Oklahoma.

“Improved cement visualization has always been one of the goals to ensure better safety with kyphoplasty and vertebroplasty. If you can visualize the cement better, it makes the procedure safer, so improved visualization by having barium particles of varying size is really nice.” says dr. Jonathan MorrisNeuroradiologist.

New Vertefix HV Cement with Insite Tracking Beads offers high viscosity and long working time and is an innovative enhancement to IZI’s spinal augmentation portfolio. “We worked with doctors to find out what would really help them with spinal augmentation procedures. Their input was insightful and we are pleased with what we were able to deliver with Vertefix HV,” said Jovie SorianoSVP Marketing and Business Development, IZI Medical.

More information about Vertefix HV is available at izimed.com/vertefixhv.

About IZI Medical Products

As an innovator, manufacturer and distributor of quality medical devices, IZI Medical provides the continuity our healthcare partners need to succeed. Situated at Owings Mills, Marylandjust outside Baltimore, IZI is a leading developer, manufacturer and supplier of high quality consumable medical devices used in Interventional Radiology and Oncology, Radiation Therapy, Neuro Spine and Image Guided Surgery procedures. IZI has built a diverse portfolio of products backed by strong intellectual property and currently sells to over 2,500 domestic and international customers in 25 countries.

Contact
Jovie Soriano
IZI Medical Products, LLC
410-753-9121
[email protected]

SOURCE IZI Medical Products

Related links

izimed.com

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Generic drugs

“A new regulation limiting generic drugs will change the industrial paradigm”

by Joan J. Dean on

The Korean Pharmaceutical and Biopharmaceutical Manufacturers Association (KPBMA) said the revision of the Pharmaceutical Affairs Act to restrict generic drugs would be an inflection point to bring about a paradigm shift in the biopharmaceutical industry.


The Korean Association of Pharmaceutical and Biopharmaceutical Manufacturers has released a report that predicts that restrictions on generic drugs will change the current paradigm of the local biopharmaceutical industry.


The KPBMA made these and other points in its latest policy report in the form of a forum, “The biopharmaceutical industry in a time of transformation.”


This policy report presented the perspectives and meanings of changes in the pharmaceutical and biotechnology industry, such as amendments to the Pharmaceutical Affairs Law, including the so-called “1+3 restriction”. The 1+3 restriction regulation limits the number of generic drugs that can be approved with a single bioequivalence test to a maximum of four, dramatically changing the industry landscape, he said.


So far, the Ministry of Food and Drug Safety has granted drug manufacturing licenses to all drug companies on the condition that they submit bioequivalence test data on foreign drugs for which patents have expired.


At the forum, Park Ji-man, the head of insurance and distribution team of KPBMA, pointed out the chronic problems in the structure of the national drug market, such as poor quality control of drugs and the rebates, caused by the excessive launches of generic drugs. , which he says led to the revision of the Pharmaceutical Affairs Act.


“Amid the ongoing Covid-19 pandemic, the biopharmaceutical industry is attracting attention as a frontrunner in national health and security, and the hope of becoming a global biopharmaceutical powerhouse is no longer a goal. industry alone, but a national goal,” Park wrote. “Therefore, for the biopharmaceutical industry to establish itself as a national industry, it must gain public trust.”


The 1+3 regulation, which heralds a major change in the industry, and the regulation requiring contract sales organizations (CSOs) to prepare and submit economic profit and expense reports will solve the cluttered general marketplace, prevent over-competition and promote industry growth, he added.


Professor Lee Tae-jin Lee of Seoul National University’s Graduate School of Public Health also expected some small and medium-sized pharmaceutical companies to face difficulties due to 1+3 restriction regulations. . “In the long term, however, regulation is necessary to ensure the healthy growth of the biopharmaceutical industry and improve the competitiveness of generic drugs,” he said.


Professor Lee pointed out that the most important task is to improve the quality and reliability of generic drugs if the nation is to improve the competitiveness of local generic drugs globally.


To achieve these goals, Lee said the country should limit the number of generic drugs, provide appropriate compensation for high-quality generics, transparency in disclosing information on the quality of generic drugs, and rapid improvement of gaps in the generic drug management system.


Boryung Pharmaceutical CEO Lee Sam-soo also agreed that there is an urgent need to reduce the number of approved generic drugs to strengthen drug quality control.


“Even a small company needs a factory manager and manufacturing quality staff, but there is no big difference in the number of items approved between small and large pharmaceutical companies,” Lee wrote. “To improve the level of good manufacturing practices (GMP) in factories, companies must design the level of quality from the R&D phase, and companies must introduce quality from the design stage, in which they define the conditions of the process. like a range rather than a single point.”


Lee also pointed out that the quantitative and qualitative improvement of the workforce engaged in quality control is a mandatory requirement.


“With the exception of some companies, there are many cases where the number of qualified personnel in relation to the articles is clearly insufficient,” he said. “Therefore, systematic training must be supported while increasing the quality of personnel.”


In the report, the KPBMA also highlighted the paradigm shift in the industry amid convergence with high-tech industries.


“There is a need for a collaboration platform that establishes a practical cooperative process for artificial intelligence (AI)-based drug development, which enables pharmaceutical companies, universities, research institutes and medical institutions to share and use new data related to drug development and analyze it in real time,” said Kim Hwa-jong, head of the AI-based New Drug Development Support Center. for that to happen, the center wants to bring a federated drug discovery (FDD) platform to the center.”


According to Kim, each institution can share a common model without creating an AI model for individual analysis using the FDD platform.


“It will minimize the difficulty of finding AI experts in each company, and the process of collaborating around high-quality data will also facilitate the discovery of new pipelines,” he said.


Professor Jeong Jae-hoon from Chonbuk National University College of Pharmacy also said that there needs to be a paradigm shift in the industry through digital therapy.


“The scope of e-medicines and digital therapies is no longer limited to mental and neurological diseases,” Professor Jeong said. “Using the relationship between nerve stimulation, immunity and metabolic function, the range of treatments for e-medicines and digital therapies has expanded to include obesity, diabetes, hypertension, cardiovascular disease and cancer.”


Jeong pointed out that a world will come in which patients with chronic diseases will not have to take the same chemical drugs.


“If the current concept of pharmaceuticals persists even at this point in the future, there will be no room for pharmaceutical companies,” he said. “As the development of these technologies will continue, the industry must create a new avenue of digital therapy and electronic medicine.”

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Medical products

Aptar Reaches Agreement with Weihai Hengyu Medical Products to Add Elastomeric and Plastic Component Manufacturing Capabilities in China for Injectable Drug Delivery

by Joan J. Dean on

CRYSTAL LAKE, Ill.–(BUSINESS WIRE)–AptarGroup, Inc. (NYSE: ATR), a global leader in drug delivery, consumer product delivery and active materials science solutions, today announced that it has entered into an agreement to acquire 80% stake in Weihai Hengyu Medical Products Co., Ltd., one of China’s leading manufacturers of elastomeric and plastic components used in the delivery of injectable drugs.

This acquisition supports Aptar’s strategic priority of building its capabilities in high-growth economies such as China, and enhances the company’s ability to meet changing local market needs, which include regional manufacturing, a well-integrated supply chain and proximity to customers and their patients. . By adding local manufacturing capability, this acquisition allows Aptar to capitalize on the growth potential of the Asian region, while strengthening the company’s ability to serve local and global customers in the injectable drug market with the best products and services in their category, a competitive lead in time and technical support, while relying on Aptar’s global network.

Commenting on the transaction, Stephan B. Tanda, President and CEO of Aptar, said:This acquisition of a majority stake is a strategic step that strengthens our competitive position in Asia and in the fast-growing market for the administration of injectable drugs. This transaction will respond to our disciplined investment approach and Hengyu’s capabilities are complementary to our growing portfolio of injectable solutions.

Xiangwei Gong, President of Aptar Asia, added:The acquisition of Hengyu will be another critical step in executing Aptar’s strategy in Asia, which targets growth in all of our core markets, including the injectable drug delivery market. We foresee strong and sustainable long-term growth in this critical application area in Asia, as more patients are prescribed drugs in injectable form for their safety, efficacy, availability and affordability.

Wang Yingye, co-founder of Hengyu, said, “Aptar is a global leader in drug delivery solutions. Hengyu shares the same vision as Aptar – to be an expert in drug delivery, providing unique, high quality products to the healthcare industry. We are delighted to have Hengyu join Aptar’s large manufacturing footprint in China and Asia.

Gaël Touya, President of Aptar Pharma, said: “We look forward to adding Hengyu’s manufacturing capacity, capabilities and expertise to our global manufacturing network to continue to be close to customers and their patients as they deliver life-saving and essential treatments every day. improve life. With the expertise of the Aptar Pharma and Hengyu teams, we will set up a new center of excellence in the region.

Located in Weihai, a coastal city in Shandong province in eastern China, Hengyu designs and manufactures elastomer and plastic components used in the delivery of injectable drugs. Hengyu was founded in 1998 and has approximately 150 employees at its factory in Weihai.

Under the terms of the agreement, Aptar will have the option to acquire the remaining 20% ​​stake in Hengyu on the fifth anniversary of the closing of the initial majority investment. The transaction is subject to customary regulatory approvals and is expected to close by the end of the third quarter of 2021. The transaction is not expected to have a material impact on adjusted earnings per share in 2021 or 2022.1. The purchase will be financed with available cash.

1Adjusted earnings per share is a non-GAAP financial measure. Additional information regarding this measure is available on the Company’s website at aptar.com on the Investors page (click Events and Presentations for a reconciliation of non-GAAP financial measures).

About Aptar

Aptar is a global leader in the design and manufacture of a wide range of drug delivery, consumer product delivery and active materials science solutions. Aptar’s innovative solutions and services serve a variety of end markets, including pharmacy, beauty, personal care, home, food and beverage. By using proprietary knowledge, design, engineering and science to create dispensing, dosing and protection technologies for many of the world’s leading brands, Aptar is in turn making a meaningful difference in the life, look, health and the homes of millions of patients and consumers around the world. . Aptar is headquartered in Crystal Lake, Illinois, and has 13,000 dedicated employees in 20 countries. For more information, visit aptar.com.

This press release contains forward-looking statements, including with respect to the potential acquisition of Hengyu and the anticipated effects of the acquisition. Future or conditional expressions or verbs such as “will”, “would” and “expect” are intended to identify these forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information we currently have. Accordingly, our actual results may differ materially from those expressed or implied by such forward-looking statements due to known and unknown risks and uncertainties that exist in our operations and business environment, including, but not limited to : the satisfaction of the closing conditions of the acquisition; the expected benefits of the acquisition; the successful integration of Hengyu; the regulatory environment; and competition, including technological advances. For more information about these and other risks and uncertainties, please see Aptar’s filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Aptar’s Forms 10-K and 10-Q. Aptar undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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Generic drugs

Schuyler County joins others in suing generic drug makers for alleged price fixing

by Joan J. Dean on

WATKINS GLEN, NY (WETM) – Schuyler County has joined more than two dozen city governments, and others, in suing generic drug makers for alleged price-fixing.

The county, along with local governments in New York and elsewhere, filed a 1,000-plus-page subpoena and lawsuit on June 30 against more than 50 businesses, seeking injunctive relief, damages and damages. which, according to the complaint, resulted from an illegal agreement. between the defendants to allocate customers, rig bids and fix, increase, maintain and/or stabilize the prices of all of their generic pharmaceutical products,

The lawsuit follows a vote by the County Legislature in 2020 allowing County Attorney Steven Getman to partner with Napoli Shkolnik PLLC, a New York City law firm “in the investigation and/or the pursuit of any legal claims against generic pharmaceutical manufacturers and/or their officers based on their actions in price fixing, market allocation and participation in other violations of antitrust laws or other wrongdoing regarding generic pharmaceuticals.

According to Getman, the lawsuit pursues claims in several areas. These include increased health insurance premiums for county employees, additional workers’ compensation costs, and higher costs for pharmaceuticals purchased for use by the county jail, all based on artificially inflated generic drug prices.

Various government agencies have already filed a lawsuit, Getman said, alleging violations of state and federal antitrust and consumer protection laws.

“In 2014, the Department of Justice launched an investigation into the prices of various generic drugs,” Getman explained. “As a result of the federal investigation, in 2017, state attorneys general from 48 states filed a civil lawsuit alleging price fixing, market splitting and other antitrust violations by 16 pharmaceutical defendant companies regarding fifteen (15) generic prescription drugs. ”

“As alleged, the defendants’ anti-competitive conduct falls primarily into two categories. First, the defendants communicated with each other to determine and agree on the market share that each would control and the customers to which each competitor was entitled. Second, competitors would have communicated – either in person, over the phone or via text – and agreed to collectively raise and/or maintain prices for a particular generic drug.

The lawsuits, Getman said, now involve more than 100 generic drugs and more than fifty pharmaceutical defendants, including Teva, Sandoz, Mylan, Pfizer, Actavis, Amneal, Apotex, Aurobindo, Breckenridge, Dr. Reddy’s Laboratories, Glenmark, Greenstone, Lannett, Lupin, Par, Taro USA, Upsher-Smith, Wockhardt USA and Zydus.

“As noted, hundreds of generic drugs have been implicated across the country. Each affected county or municipality can file a lawsuit asserting overpayments for each applicable generic drug,” Getman explained. “The key issue in formulating a lawsuit was to determine for which generic drug(s) each county had overpaid, and whether each was the direct or indirect purchaser.”

According to County Administrator Tim O’Hearn, the lawsuit was filed without risk to the county, as Napoli Shkolnik is working on an emergency basis which covers all costs associated with the lawsuit.

“By moving forward with litigation, the County Legislature hopes to ease the burden on taxpayers and seeks to hold manufacturers accountable for any illegal role in the high cost of generic drugs,” O’Hearn said.

Locally, along with Schuyler County, Chemung, Yates and Livingston counties are acting as plaintiffs in the lawsuit. Other municipalities in New York and elsewhere are also part of the deal. The case is currently set to be heard in federal district court for eastern Pennsylvania.

In addition to the generics case, Schuyler County worked with Napoli Shkolnik to pursue an ongoing lawsuit against manufacturers and distributors of prescription opiates for damages to the county resulting from the fraudulent marketing and distribution and negligent opiates in and to the county. . This case remains pending in state court.

A related lawsuit, involving Nassau and Suffolk counties, and the New York State Attorney General’s office, is currently underway on Long Island against several companies accused of fueling the opioid crisis. The lawsuit in Long Island will serve as a test for the claims of Schuyler County and other New York municipalities, as well as an indicator of what could happen to drugmakers, distributors and pharmacies in other states.

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Generic drugs

Does Medicare Exceed Expenses? Costco costs much less for generic drugs | Health info

by Joan J. Dean on

By Robert Preidt, health day reporter

(Health Day)

WEDNESDAY, July 7, 2021 (HealthDay News) — Can Costco beat Medicare Part D when it comes to prescription drug prices?

Apparently, that’s what a new study claims that found about half of generic drugs were cheaper when purchased from the discount retailer than through the government program.

Researchers compared the prices paid by Medicare Part D plans (including direct patient payments) for 184 generic prescription drugs to the cash prices paid by Costco members for the same prescriptions in 2017 and 2018. More than 45 million Americans are enrolled in Medicare Part D, which covers outpatient prescriptions.

Compared to Costco member prices, Medicare plans topped 13% in 2017 and nearly 21% in 2018, the results showed. Medicare plan participants paid more than Costco members on nearly 53% of 90-day fills in 2018. Of all 30- and 90-day prescription fills, Medicare plans overpaid 43% of the time, researchers found. from the University of Southern California (USC). .

“Our analysis shows that in systems like Costco’s, where incentives are put in place to deliver value directly to the consumer at the pharmacy counter, this is what happens,” the author said. Erin Trish study. She is associate director of the USC Schaeffer Center and assistant professor of pharmaceutical and health economics at USC’s School of Pharmacy.

“It’s time to fix these incentives in the Medicare Part D system to put the patient first,” Trish said in a USC press release.

His team published their findings online July 6 as a research letter in JAMA internal medicine.

Pharmacy benefit managers and other intermediaries negotiate drug prices on behalf of Medicare, but they do not appear to pass all of the savings on negotiated prices to plans and patients, the researchers said.

Generic drugs account for 22% of Part D spending, so policymakers should take a closer look at the practices of these intermediaries, the team suggested.

Study author Geoffrey Joyce is director of health policy at the Schaeffer Center and chair of the department of pharmaceutical and health economics at the USC School of Pharmacy. He said: “Efforts to reduce prescription drug prices tend to focus on brand name drugs, but the opaque pharmaceutical supply system can also lead health plans and taxpayers to overpay for generics.”

And Karen Van Nuys, executive director of the Schaeffer Center’s Life Sciences Value Innovation Program and assistant professor at USC’s School of Public Policy, added, “There’s a lot of price competition among manufacturers of these drugs, but this competition does not benefit the These are not small market drugs where there may be only one supplier who can quote their price. »

SOURCE: University of Southern California, press release, July 6, 2021

Copyright © 2021 Health Day. All rights reserved.

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Generic drugs

Branded or Generic Drugs: Which is Better?

by Joan J. Dean on

Generic drugs contain the same active ingredient as their brand name counterparts. However, they usually cost much less than the branded version.

Before the Food and Drug Administration (FDA) approves a generic drug, the drug must meet rigorous approval standards. The FDA stipulates that the generic drug must be “pharmaceutically equivalent” to its brand name version.

This ensures that generic drugs have the same purity, strength, stability and quality as branded drugs.

However, not all brand name drugs are available in low cost generic form.

Read on to find out how branded and generic drugs compare in price, appearance, availability, and more.

Generally, generic drugs cost less than their brand name equivalents. The price can be up to 85% lessaccording to the FDA.

There are several reasons for this.

Research costs

Generic drugs benefit from reduced initial research costs.

Brand-name drugs have to go through expensive animal and clinical studies to prove their safety and effectiveness. Generic drugs use the same active ingredients as tested brand name drugs, so they don’t have to perform the same tests. This saves drug producers money, and consumers then benefit from these savings.

Competetion

When more than one company produces a generic version of the same drug, there is more competition. Generally lower prices go hand in hand with more competition.

People are aware of these price differences, and this affects the choice of drugs.

A cross-sectional study of 278 volunteers examined participants’ understanding of generic drugs. The results showed that 88.8% of the volunteers knew that generic drugs are cheaper than branded drugs, and 80.2% said they chose generic drugs because of the lower price.

Appearance

Branded and generic drugs must contain same active ingredient. However, drug characteristics that do not affect safety or efficacy may be different. This includes their appearance.

US trademark laws do not allow generic drugs to look exactly the same as equivalent brand name drugs. However, the magnitude of these differences is regulated.

When a company wishes to obtain authorization to produce a generic drug, it must file an “Abbreviated New Drug Application” or ANDA. These are filed with the FDA Office of Generic Medicines (OGD). Generic drugs may have different physical characteristics than their brand name counterparts.

Significant differences in specifications such as size and color may:

  • negatively affect a person’s compliance with treatment
  • make it difficult for doctors and their patients to identify the drug
  • lead to the placebo effect, where a person believes that a treatment with no therapeutic value is working
  • lead to the nocebo effect, where a person’s negative expectations of a treatment cause it to have a more negative effect on them

AMG has developed a guidance document to help generic drug manufacturers produce drugs similar in shape and size to their brand name counterparts. It provides parameters from a manufacturing and safety perspective.

The FDA requires generic drugs to meet a number of standards before approval. These include:

  • The generic drug is “pharmaceutically equivalent” to the brand name drug.
  • The manufacturer can produce the generic drug correctly and consistently.
  • The generic drug contains the same “active ingredient” as the brand name drug.
  • The correct amount of the active ingredient reaches the target area of ​​the body.
  • The “inactive ingredients” of the generic drug are safe.
  • The vial, box or other container of the generic medicine is suitable.
  • The generic drug label is the same as the brand name drug.
  • The generic drug does not deteriorate over time.
  • Legal exclusivities or patents have expired.

The pharmaceutical company must submit an ANDA, which is an abbreviated New Drug Application. It states that the generic drug meets each standard.

People taking a particular medication may want to know if there is a cheaper generic option. There are several ways to find out if there is a generic version of a brand name drug:

  • Ask the prescribing doctor or pharmacist.
  • Find the drug using the FDA [email protected] system. Look for the brand name drug first.
  • Look up the medicine using the online version of the Orange Book. Look for the brand name drug first.
  • Consult the FDA list of first generic drug approvals. This is where people can find “first generics” – the first time the drug gets FDA approval.

According to AMGall FDA-approved generic drugs must meet the same quality, purity, strength, and stability requirements as their brand name counterparts.

When comparing study health insurance claims in the United States, researchers found that brand name and generic drugs had comparable medical outcomes for chronic physical conditions. The conditions they looked at included hypertension, diabetes, osteoporosis and psychiatric disorders such as anxiety and depression.

However, another analysis found that generic drugs may not have the same clinical impact for cardiovascular disease.

The researchers analyzed reports from the scientific databases MEDLINE and EMBASE. They found that while 60% of the studies reported no difference between the drugs, the risk of hospital visits was higher in people taking the generic.

It is important to note that this study simply showed a correlation. It did not show that the generic drug played a role in increasing hospital visits.

People of lower socioeconomic status tend to have worse health outcomes that others. Also, because they have less disposable income, they may be more likely to choose a generic drug over a brand name drug. One could therefore conclude that some people taking the generic drug in greater numbers are already predisposed to poorer health outcomes.

The study researchers also state that there is not enough evidence to draw firm conclusions.

When determining the best option between brand name drugs and generic drugs, a person’s healthcare professional may consider the specific medical condition and current research when prescribing medications.

In a 2015 report, the American College of Physicians called on doctors to prescribe generic drugs rather than brand name drugs whenever possible.

Learn more about why doctors should prescribe generic drugs.

When choosing which drug to take, a person considers several factors.

Ultimately, it is up to the individual and their healthcare professional to determine the best option from the brand name and generic medications available.

Quality

The pharmaceutical company must submit an ANDA showing that the generic drug meets each standard required by the FDA before the FDA approves it. This includes demonstrating that the generic drug is pharmaceutically equivalent to the brand name drug.

Therefore, people can be sure that the generic drug option is of the same quality as the brand name version.

attitude and intention

Researchers have found that three main categories shape a person’s attitude towards generic drugs and their intention to purchase them. These are:

  • Consumer attitude and behavior: It is a combination of a person’s beliefs and feelings about a product and their behavioral intention towards that product.
  • Consumer Opinions: These include the perspective of a person and their healthcare professional regarding generic medicine.
  • Risks: This includes the risks, if any, associated with the generic drug.

Researchers say that if the pharmaceutical industry, public health policymakers and medical professionals better understand consumer attitudes and behaviors toward generic drugs, they could help expand drug use. generics.

Cost

In 2017, researchers conducted a economic evaluation brand name drug prices. It focused on 49 top-selling drugs that had more than 100,000 pharmacy claims that year.

Of these 49 brand name drugs, 48 ​​showed regular annual or semi-annual cost increases.

Generic drugs cost less than their brand name equivalents. For some people, this cost difference is the deciding factor in whether they are able to take a much-needed medication.

Branded and generic drugs contain the same active ingredients in the same amounts. In most cases, they provide the same therapeutic benefits. Although more research is needed to determine whether brand name drugs are better for certain conditions, the American College of Physicians says doctors should prescribe generics where available.

Because they don’t have to undergo the same human and animal studies as brand-name drugs, FDA-approved generic drugs are significantly less expensive. This price difference influences some people’s decision to choose generic drugs over brand name drugs.

However, it is advisable to discuss brand name and generic drug options with a medical professional. This allows a person to make the right decision based on their health and personal situation.

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Generic drugs

Substandard generic drugs are flooding the US market and putting all Americans at risk

by Joan J. Dean on

Find out what clicks on FoxBusiness.com.

Most Americans would be shocked to learn that millions of doses of low-quality and potentially harmful generic drugs are imported into the United States every year. Despite safety concerns, hospitals continue to use them every day. And supermarket pharmacies, big box stores and corner pharmacies continue to sell it.

Many in Washington will point the finger at the FDA. But the real problem is that American companies are choosing profit over safety by importing and selling substandard generic drugs across the country.

These American companies include large buying groups and wholesalers who follow a very lucrative business model. They simply scour the world for the cheapest generic drugs, often from China and India. For them, the lower the purchase price, the higher the profit margin, regardless of where and how the drugs are produced.

An example is a generic muscle relaxant given to COVID-19 patients on ventilators. At the start of the pandemic, the drug was in short supply. In response, the FDA approved imports from a manufacturer that had received warning letters from the FDA. These drugs must be manufactured under sterile conditions. But the agency warned the company of its failure to prevent contamination of its supposedly sterile drugs.

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These concerns could be avoided if drug buyers put safety over profit and bought generic drugs from reputable manufacturers in the United States. Instead, in their endless quest for cheaper drugs, they choose to ignore safety and quality issues.

This race to the bottom for generic drug prices has driven ethical manufacturers out of business and caused the collapse of the US generic drug manufacturing industry. As a result, the United States now depends on China for thousands of generic drugs, as Beijing controls the supply of basic components for drug manufacturing.

US DONATES 500 MILLION DOSES OF COVID-19 VACCINE TO LOW-INCOME COUNTRIES

With the United States now increasingly dependent on imported drugs, doctors, nurses, pharmacists and patients are the first to witness the risks associated with substandard generic imports.

A recent medical journal study reported the life-threatening risks of a generic drug used to treat patients recovering from heart and lung transplants. Researchers found that a generic drug made by two foreign companies did not dissolve properly, hampering its effectiveness and posing life-threatening risks.

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Ordinary drugs don’t meet US standards either. The FDA has warned a maker of a common asthma drug, albuterol, about sterility issues and the risk of contamination from other drugs made at the same facility.

When American companies buy imported drugs at the best possible price, they incur other costs. Patients suffer serious setbacks — blood pressure spikes, failed organ transplant recovery and uncontrolled seizures — when their generic drugs don’t work.

In the worst case scenario, Americans are dying from dangerous drugs purchased by American companies. In 2007 and 2008, for example, hundreds of Americans died from contaminated supplies of Chinese-made heparin.

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In 2018, millions of Americans learned that their blood pressure medications contained a cancer-causing chemical. A Chinese manufacturer, whose product contained the highest amount of the carcinogen, was later banned by the FDA.

It is time to impose a cost on traders of substandard imported drugs. To do this, the United States must once again manufacture these generics at home.

To realistically support U.S. generic drug makers as they compete with cheap imports, Congress should impose “Buy American” requirements on the Department of Defense and the Veterans Administration. Similarly, national procurement policies should also be extended to Medicare and Medicaid.

Americans need safe, quality medicines. Washington must not allow special interests to buy substandard drugs and sell them in the United States. It’s time to bring these vital supply chains home, so that American lives are not at risk.

Rosemary Gibson is chair of the Coalition for a Prosperous America’s Healthcare Committee and author of “China Rx: Exposing the Risks of America’s Reliance on China for Medicine.”

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Generic drugs

Anthem joins the CivicaScript initiative to reduce the cost of certain generic drugs

by Joan J. Dean on

Photo: AJ Mast/Getty Images

Civica Rx, the nonprofit organization founded in 2018 by Intermountain Health Systems, Mayo Clinic, Providence St. Joseph Health and others to address generic drug shortages and high costs, announced the added Anthem to his initiative.

Anthem joins Civica Rx’s operating unit, CivicaScript, as a new health insurance partner, joining the entity’s co-founders, the Blue Cross Blue Shield Association and 17 independent, locally operated Blue Cross and Blue Shield companies.

Together, CivicaScript partners represent nearly 100 million lives, the organization said.

WHY IT’S IMPORTANT

While many generic drugs cost less than brand name drugs, some expensive generics are more expensive due to lack of competition in the market. Generic drugs account for almost 90% of all prescriptions. Numerous studies confirm that drug costs can dictate whether patients fill or ration their generic prescriptions.

CivicaScript aims to reduce the cost of some expensive generic drugs. It will initially develop and manufacture six to 10 common but expensive generic drugs for which there is currently not enough market competition to bring prices down, Civica said.

Using a cost-plus model and price transparency, CivicaScript also plans to provide these drugs to U.S. patients at a fraction of their current cost, saving consumers hundreds of millions of dollars annually within a few years. the launch, the company said.

The first generic CivicaScript drugs will be available from 2022 in retail and mail-order pharmacies.

Catalent, a global drug development and manufacturing company, has entered into a long-term partnership with CivicaScript to produce essential generic drugs that are widely prescribed to patients. Catalent will develop a CivicaScript-owned line of abbreviated generic drugs at its oral solids facilities in Somerset, New Jersey and Winchester, Kentucky.

Gina Guinasso, former OptumRx executive, joined as president of CivicaScript. She previously served as Senior Vice President of Business Strategy and Medicare Formulary for OptumRx, and prior to that role, she held leadership roles in federal and state policy, reimbursement strategy, and account management. payers at Takeda Oncology, Cubist Pharmaceuticals and Acorda Therapeutics.

THE GREAT TREND

Civica Rx was founded in 2018 by CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health and Trinity Health and three philanthropic organizations, the Laura and John Arnold Foundation, the Peterson Center on Healthcare and the Gary and Mary West Foundation, to address generic drug shortages and high costs.

Kaiser Permanente and Memorial Hermann Health have since joined these organizations on the Civica board. Since its inception, more than 50 health systems — representing nearly 1,400 hospitals and one-third of all licensed hospital beds in the United States — have joined.

In 2020, Civica and the BCBS Companies announced the creation of a new, yet to be named subsidiary – now CivicaScript – that would focus on providing lower-cost generic prescription drugs directly to consumers in hospitals. or retail pharmacies.

All members of the Civica Hospital System will have access to retail medications manufactured by CivicaScript. The company invites other health plans, employers, pharmacies and health innovators to become partners.

REGISTRATION

“By partnering with CivicaScript and introducing original and inventive approaches, we look forward to making expensive drugs more affordable,” said Jeffrey Alter, executive vice president, IngenioRx and Anthem Health Solutions.

Catalent’s President and CEO, Alessandro Maselli, said, “Our experts in Somerset and Winchester have a proven track record in developing and launching new medicines, and with CivicaScript we are able to offer a robust and efficient supply chain that can help increase access to life-saving medicines.”

Twitter: @SusanJMorse
Email the author: [email protected]

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Generic drugs

Contaminants found in many generic drugs can cause harmful effects, new study finds

by Joan J. Dean on
Science, health and technology

June 15, 2021 | for more information contact Collins Maina

Contaminants in generic drugs used to treat conditions such as diabetes, heart disease, stomach ailments and heartburn can damage DNA, affect function, new study from UBC finds basic cells and even increase the risk of cancer.

Dr. Corey Nislow

“When we take these drugs, we do so knowing that they may cause side effects that are clearly described on the drug label. But what we don’t expect is that our medicine cabinet may be full. of toxins that can actually make us sick – or kill us,” says Dr. Corey Nislow, commenting on the findings of researchers from his lab at UBC’s School of Pharmaceutical Sciences.

People need to be especially vigilant about the contaminant N-nitrosamine – a nitrogen group attached to an amine group – considered a dangerous combination because amines react with anything in a cell, while nitrogen groups can block cellular processes, says Dr. Nislow.

First author and Ph.D. candidate Uche Joseph Ogbede says that for the first time they were able to see the effects of nitrosamines on cells, paving the way for solutions to reduce toxicity.

Nitrosamines were first noticed as an impurity in heart medications which also often contain valsartan or losartan as active ingredients. Since 2018, this type of toxin has led to multiple recalls of contamination by Health Canada and the United States Food and Drug Administration (FDA). They are found in generics as early as 2012 and nitrosamines are now found in many types of medications.

Although there have been no serious consequences or documented deaths from short-term use, Dr. Nislow is concerned about the long-term effects. “We lack good data on this and the long-term consequences are a big unknown,” he notes.

Generic drugs are produced cheaply overseas and purchased in larger quantities, Dr Nislow says, and they are more widely used than their branded versions, which have higher quality control but are more expensive to produce. .

“It’s easy to assume that generic drugs for common conditions are equivalent to the brand name version, but in reality they could be made with entirely different ingredients,” says Dr. Nislow.

These contaminants are found in hundreds of millions of generic drug prescriptions used for chronic conditions where people may use them for long periods of time.

Studying yeast to find answers

The research team used a yeast-based test system from Dr. Nislow’s previous work to study the contaminants.

They examined 4,800 strains of yeast with tagged DNA, looking for those that were more sensitive and resistant after being exposed to contaminants and found that the contaminants had significant effects on DNA repair and the machinery that makes the cells. cellular proteins, which Dr. Nislow says is one of the oldest cellular processes.

The contaminants they studied also affected the cell’s mitochondria, which is believed to have adverse effects on people’s ability to efficiently convert food into energy.

“So the very things that these drugs are used to treat could ultimately be affected by the contaminants,” says Dr. Nislow.

Higher quality control is needed

The study recommends better safety and monitoring of the drug supply chain, in addition to more research into the long-term effects of these contaminants.

Dr. Nislow hopes that in the future there can be more transparency with generic drugs and stricter government measures regarding the quality control of these drugs.

The study is published in Scientific reports.

Interview language(s): English

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Generic drugs

Global Generic Drugs Market Report 2021: Market to Exceed $750 Billion by 2030

by Joan J. Dean on

DUBLIN, June 4, 2021 /PRNewswire/ — The report “Generic Drugs Market Research Report: By Type, Application, Route of Administration, Distribution Channel – Global Industry Analysis and Demand Forecast to 2030” has been released. added to from ResearchAndMarkets.com offer.

The size of the global generic drugs market at $786.0 billion by 2030 from $278.4 billion in 2019, at a CAGR of 10.0% between 2020 and 2030.

Generic drugs are cost-effective, at the same time contain the same active ingredients and have a similar effect to patented drugs. In this regard, the generic drug market is also driven by patent expirations for blockbuster drugs. As patented drugs lose their certification, this gives pharmaceutical companies the opportunity to create their cheaper but equally effective variants.

During the COVID-19 crisis, the generic drug market received a boost as governments around the world, despite putting in place lockdowns and movement restrictions, ensured that the supply of drugs essentials are not hindered. Moreover, as people have lost their jobs or are working with reduced wages, they are cutting down their expenses drastically, which is why the preference for cheap generic drugs over expensive patented drugs has increased.

In the near future, the highest CAGR in the generic drug market of 10.4% is expected to be shown by the oral category, based on the route of administration. Being the easiest and painless method of administering drugs, it is very popular among the masses.

Indirect forking generates the highest revenue in the generic drug market, in the distribution channel segment. Most people prefer to buy medicines from hospitals, clinics and pharmacies/chemists, all of which are increasing in number around the world due to the increasing number of patients.

Asia Pacific (APAC) has so far made the largest contribution to generic drug market revenue, and will continue to do so throughout this decade. The growing geriatric population and the burden of acute and chronic diseases are driving the demand for drugs. Moreover, majority of the people here still cannot afford the expensive drugs, that’s why they opt for the cost-effective generic drugs.

Main topics covered:

Chapter 1. Research Context

Chapter 2. Research Methodology

Chapter 3. Executive Summary

Chapter 4. Overview
4.1 Market definition
4.1.1 By type
4.1.1.1 Single
4.1.1.2 Great
4.1.1.3 Biosimilars
4.1.2 By Application
4.1.2.1 Neurological diseases
4.1.2.2 Cardiological diseases
4.1.2.3 Metabolic diseases
4.1.2.4 Infectious diseases
4.1.2.5 Orthopedic diseases
4.1.2.6 Respiratory diseases
4.1.2.7 Genito-urinary/hormonal diseases
4.1.2.8 Others
4.1.3 By route of administration
4.1.3.1 Oral
4.1.3.2 Injection
4.1.3.3 Dermal
4.1.3.4 Mucosal
4.1.3.5 Inhalation
4.1.3.6 Others
4.1.4 By distribution channel
4.1.4.1 Indirect
4.1.4.2 Direct
4.2 Market Dynamics
4.2.1 Trends
4.2.1.1 Change in preference to generic drugs
4.2.1.2 Increase product launches
4.2.1.3 Growing number of collaborations and partnerships
4.2.1.4 Increase in the number of mergers and acquisitions
4.2.2 Drivers
4.2.2.1 Increase in the aging population
4.2.2.2 Expiration of blockbuster patents
4.2.2.3 Growing prevalence of acute and chronic diseases
4.2.2.4 Increase in R&D spending by biotech and pharmaceutical companies
4.2.2.5 Impact Analysis of Drivers on Market Forecast
4.2.3 Constraints
4.2.3.1 Strong commercialization of branded drugs eclipses generics
4.2.3.2 Physician preference for brand name drugs
4.2.3.3 Market Forecast Restrictions Impact Analysis
4.2.4 Opportunities
4.2.4.1 Generic-friendly regulations
4.3 Impact of COVID-19
4.3.1 Supply Analysis
4.3.1.1 Current Scenario of Major Generic Manufacturers and Exporters
4.3.1.2 Containment situation and workforce availability
4.3.1.3 Manufacturing scenario
4.3.1.4 Situation of the main countries supplying generic drugs
4.3.2 Demand Side Analysis
4.4 Porter’s Five Forces Analysis

Chapter 5. Global Market Size and Forecast
5.1 By type
5.2 By Application
5.3 By administration
5.4 By distribution channel
5.5 By region

Chapter 6. North America Market Size and Forecast

Chapter 7. Europe Market Size and Forecast

Chapter 8. APAC Market Size and Forecast

Chapter 9. LATAM Market Size and Forecast

Chapter 10. MEA Market Size and Forecast

Chapter 11. Competitive Landscape
11.1 Strategic Developments of Key Players
11.1.1 Product launches and approvals
11.1.2 Partnerships
11.2 Key Players and Their Offerings

Chapter 12. Business Profiles

  • cipla ltd.
  • Dr. Reddy’s Laboratories Ltd.
  • Alkem Laboratories Limited
  • Teva Pharmaceutical Industries Limited
  • Mylan AG
  • Lupine Limited
  • Endo International plc
  • Aurobindo Pharma Limited
  • STADA Arzneimittel AG
  • Hikma Pharmaceuticals plc
  • Sawai Pharmaceutical Co. Ltd.
  • Piramal Enterprises Ltd.
  • Mallinckrodt plc
  • Torrent Pharmaceuticals Ltd.
  • Amneal Pharmaceuticals Inc.
  • Taro Pharmaceutical Industries Ltd.
  • Perrigo Company plc
  • Alvogene
  • Nichi-Iko Pharmaceutical Co. Ltd.
  • Glenmark Life Sciences Limited
  • Amphastar Pharmaceuticals Inc.
  • MSN Laboratories
  • CUSTOPHARM INC.
  • Cadila Healthcare Ltd.
  • Pfizer Inc.
  • Sanofi
  • Bausch Health Companies Inc.

For more information on this report visit https://www.researchandmarkets.com/r/gr7oli

Media Contact:

Research and Markets
Laura Woodsenior
[email protected]

For EST office hours, call +1-917-300-0470
For USA/CAN call toll free +1-800-526-8630
For GMT office hours call +353-1-416-8900

US Fax: 646-607-1904
Fax (outside the US): +353-1-481-1716

SOURCE Research and Markets

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Generic drugs

Major players are Aspen, Cipla, Lupin, Pfizer, Sanofi, Sun Pharmaceuticals and Teva Pharmaceuticals

by Joan J. Dean on

DUBLIN, June 2, 2021 /PRNewswire/ — Report “Global Generic Drugs Market 2020-2025” has been added to from ResearchAndMarkets.com offer.

The global generic drugs market is expected to grow from $411.6 billion in 2020 for $650.3 billion by 2025, at a compound annual growth rate (CAGR) of 9.6% for the period 2020-2025.

The nature and structure of the generic drug industry is discussed, with profiles of the more than 20 generic pharmaceutical companies and an update on mergers and acquisitions activity. Five-year sales forecasts are provided for the national markets and the main therapeutic classes of the products concerned.

This report comes at a time when the pharmaceutical industry is facing challenges and changes more drastic than any it has faced in the past half-century. The global economic recession of 2008 had a profound impact on an industry that is normally resilient to the usual ups and downs of commercial life. Besides the sometimes painful process of cost cutting and restructuring, the industry has had to deal with the fact that its business environment has fundamentally changed since all its customers now know the prices.

In this critical period, the pharmaceutical world also went through a phase for which the label “patent cliff” was invented. A stream of blockbuster drugs began to lose patent protection and R&D pipelines were unable to produce a satisfactory supply of replacements. The doors have been opened for generic drug producers to do what they do best: provide low-cost alternatives.

And there is additional complexity. Over the past two decades, advances in biotechnology have led to the introduction of a generation of biotherapeutic agents that are often more effective than traditional small molecule drugs in treating their target diseases. The first of these biotherapeutics are now losing their patent protection, providing yet another opportunity for generic copies – although this is a technically difficult area, as we will see. In fact, the challenges faced by “originator” companies – the major suppliers of own-brand pharmaceuticals – are matched by those faced by generic drug suppliers.

Generic drug suppliers initially relied on low cost as their primary business advantage. This has become a powerful argument, as the Ministries of Health of most European countries with national health schemes have started to introduce measures to reduce pharmaceutical expenditure. In the United States, the evolution of managed care has had a similar effect. Everywhere, these cost reduction exercises favored generics.

However, the low cost argument that had been the main justification for generic products worked against the commercial promise of this sector of the industry. This happened in part because the appeal (and therefore the potential for high-volume sales) of blockbuster drugs remained in place after those drugs lost patent coverage. Generic drug companies competed to introduce low-cost copies, and they were pressured to sell to the point that a year after the patent on the original brand expired, the average price of copycat products no longer was only 20% or less of the original price.

In part, too, generic price competition has been fueled by government reimbursement measures, which have favored low-priced drugs and thus tended to trigger further price cuts among generic contenders.

This development had two far-reaching effects. First, he began to weed out the weaker generic drug companies in favor of companies that had the means and the will to exist in an environment where profit margins were severely reduced, sometimes to less than 10%. One of the survival strategies adopted by these manufacturers has been to broaden their appeal beyond simple cost-cutting, to include, for example, value-added “super generic” products, often in the form of low-cost formulations. special issue.

Company profiles of key players operating in the global generic drugs market including aspenCipla, Lupin, Pfizer, Sanofi, Sun Pharmaceuticals and Teva Pharmaceuticals

Main topics covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market Overview

  • Recent history of the generic drug industry
  • Rock Bolar
  • Generic Lobby
  • PCI

Chapter 4 Impact of COVID-19

  • Short-term impact on the pharmaceutical industry
  • Long-term impact on the pharmaceutical industry
  • Impact of COVID-19 on the generic drug market
  • Supply chain impact

Chapter 5 The new era of generics

  • The Patented Cliff
  • Types of generic drugs
  • Simple Generics
  • Super generics
  • Biosimilars
  • ANDA (abbreviated new drug application) approvals

Chapter 6 Major Issues in the Generic Drugs Market

  • Regulatory environment
  • WE
  • European Union
  • Japan
  • Regulation of biosimilars
  • EU provisions
  • Developments in the United States
  • Cost of using
  • Defensive strategies used by Big Pharma
  • Authorized generic drugs
  • Cost of using
  • Climate change for generics
  • situation in Europe
  • Patents and intellectual property
  • Supplementary Protection Certificates

Chapter 7 Global Generic Drugs Market

  • Global pharmaceutical market: brand name and generic drugs
  • Global Generic Drugs Market
  • Market opportunities by product category
  • Pharmaceutical drug market shares by therapeutic area

Chapter 8 Market Breakdown by Region

Chapter 9 Industry Trends

  • Competitive landscape
  • Market trends
  • Structure of the generic drug industry
  • Recent mergers and acquisitions
  • Brand Company Involvement

Chapter 10 Business Profiles

  • Aspen Holdings
  • Cipla inc.
  • Fresenius Kabi
  • Lupine Ltd.
  • Mylan Inc.
  • Pfizer Inc.
  • Sandoz International GmbH
  • Sanofi
  • Sun Pharmaceutical Industries Ltd.
  • Teva Pharmaceutical Industries Ltd.

Chapter 11 Other International Companies

  • Aurobindo Pharma Ltd.
  • Dr. Reddy’s Laboratories Ltd.
  • Egis Pharmaceuticals Plc
  • krka
  • By Pharmaceutical Inc.
  • Arzneimittel Stadium
  • Strides Shasun Ltd.
  • Wockhardt Ltd.
  • Zydus Cadila

For more information about this report visit https://www.researchandmarkets.com/r/1qm754

Media Contact:

Research and Markets
Laura Woodsenior
[email protected]

For EST office hours, call +1-917-300-0470
For USA/CAN call toll free +1-800-526-8630
For GMT office hours call +353-1-416-8900

US Fax: 646-607-1904
Fax (outside the US): +353-1-481-1716

SOURCE Research and Markets

Related links

http://www.researchandmarkets.com

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Loans

MAIN STREET LENDING PROGRAM DOCUMENTS: RIGHTS AND ROLES

by Joan J. Dean on

The $600 billion Main Street Loan program has been highly anticipated to provide financial support in the form of loans to small and medium-sized U.S. businesses affected by the COVID-19 pandemic. The Federal Reserve Bank of Boston that is administering the Main Street Loan program has released term sheets and various other program documents for the three types of loans, “New,” “Priority” and “Expanded,” as well as over 70 pages of Frequently Asked Questions (FAQs). As a result, the contours of the Main Street Loan program are now substantially settled[1] as the Fed announced publicly on Monday, July 6, that the Main Street Lending Program is now fully operational and ready to purchase participations ineligible loans that are submitted to the program by registered lenders (Eligible Lenders).

A key feature of the Main Street Lending Program is the interplay between several program documents, in particular the Participation Agreement, the Assignment-in-Blank, and the Co-Lender Agreement, and the impact such program documents may have in default scenarios.

The Participation Agreement governs the relationship between the federal government’s special purpose vehicle which will be purchasing participations in Main Street loans (the Main Street SPV) and the Eligible Lender making such Main Street loans.  The Participation Agreement is based on the widely adopted model participation agreement form developed by the Loan Trading and Syndication Association (the LSTA) for par and near par loan transactions (but with some important distinctions described below), and sets forth (i) the framework for the Main Street SPV’s participation in a Main Street loan, including mechanisms for the sharing of payments, costs and expenses, (ii) representations, warranties, indemnification and standard of care provisions, (iii) the Main Street SPV’s voting rights with respect to certain specified issues, (iv) the Main Street SPV’s right to elevate its participation in the Main Street loan to assignment, such that it (or its assignee) becomes a direct lender under the Main Street loan, and (v) the Main Street SPV’s right to transfer its interests in the Main Street loan both before and after elevation.

The Participation Agreement also includes two useful additions: (i) it makes explicit that the participation is irrevocable and that neither party has the right to require the Eligible Lender to repurchase or buy-back the participation or the Main Street SPV to sell or put back the participation, and (ii) the Main Street SPV’s waiver of administrative priority status under Section 507(a)(2) of the Bankruptcy Code.  By expressly including in both the form of Participation Agreement and the Co-Lender Agreement an express waiver by the Main Street SPV of any claim it may have under Section 507(a)(2) of the Bankruptcy Code, the Fed pre-emptively addresses an important concern of Eligible Lenders that creditor claims of the Main Street SPV in a bankruptcy proceeding involving the borrower (or a co-obligor) as to the unsecured portion of Main Street loans would be treated differently under the Bankruptcy Code (e.g., accorded administrative priority) than the ordinary unsecured claims of Eligible Lenders and other unsecured creditors.   Section 507(a)(2) specifically provides Federal Reserve Banks with an administrative priority claim (under Section 503(b)) as to any unsecured claims related to “loans made through programs or facilities [like the Main Street loan programs] authorized under section 13(3) of the Federal Reserve Act.”  The waiver is intended to provide Eligible Lenders comfort that bankruptcy courts will follow and enforce the 95/5% economic risk allocation of the Main Street loan programs.

The Assignment-in-Blank is to be signed in blank by both the Eligible Lender and the borrower at the time the Main Street loan is made in order to facilitate the Main Street SPV’s elevation (or elevation and transfer) of its participation in the event a “Specified Permitted Transfer” (discussed below) occurs.  In doing so, the Eligible Lender and the borrower are providing the Main Street SPV with their advance consent to such an elevation or elevation and transfer.  The form is for use with bilateral facilities.  Alternatively, in the case of an Expanded Main Street loan being added to a multi-lender facility with customary syndicated loan provisions, the parties are to use the existing assignment and assumption.

The Co-Lender Agreement is also to be signed by both the Eligible Lender and the borrower at the time a bilateral Main Street loan is made.  This agreement provides the agency and operational mechanics to accommodate multiple lenders in the event the Main Street SPV elevates or elevates and transfers its participation interest.  The Co-Lender Agreement includes joinder provisions to admit the new Oak Park Financial offerings lender as an additional lender under the loan documents and to grant such lender the benefit of any guarantees and collateral documents supporting the Main Street loan, as well as provisions designating the Eligible Lender as the Administrative Agent to act on behalf of all lenders, permitting the further assignment and transfer of the loans, and governing the inter-creditor relationships among the lenders, including as to payment sharing and voting rights.

Elevation and Transfer

The Main Street SPV may seek an “elevation” of its participation interest to an assignment, thereby becoming a direct lender to the Eligible Borrower, under the following circumstances: (i) such elevation constitutes a Specified Permitted Transfer, (ii) with the prior consent of the Eligible Lender, or (iii) if any action or inaction by the Eligible Lender with respect to a Core Rights Act (discussed below) would result in any Loan Forgiveness[2].  Prior to the occurrence of an elevation, the Main Street SPV may sell, assign or grant sub participation in its participation interest without the consent of the Eligible Lender only if such action constitutes a Specified Permitted Transfer.

A “Specified Permitted Transfer” includes (a) an elevation, pre-elevation transfer or sub participation when (i) a payment default has occurred under any Main Street loan document, (ii) specified insolvency events have occurred with respect to the borrower or Eligible Lender, or (iii) required by statute or court order; (b) an elevation when any action or inaction by the Eligible Lender with respect to a Core Rights Act (as discussed below) would result in any Loan Forgiveness; or (c) any pre-elevation transfer or sub participation to specified governmental assignees.

At any time after an elevation, the Main Street SPV may assign, grant participation in, or otherwise transfer all or any portion of its rights in the Main Street loan without the consent of the Eligible Lender, but subject to the requirements of the Co-Lender Agreement (for bilateral facilities) or the assignment provisions of the underlying loan documents (for multi-lender facilities), as applicable. 

The Co-Lender Agreement requires the consent of the Eligible Borrower (provided no event of default then exists) and the “Administrative Agent” for assignments unless such an assignment is to another current lender under the facility (or its affiliates or approved funds) or to specified governmental assignees.  Importantly, the Co-Lender Agreement designates the Eligible Lender as the Administrative Agent for purposes of the bilateral facility, so in this capacity, the Eligible Lender does obtain a consent right to post-elevation assignments.

In contrast, the Eligible Lender is prohibited from assigning or transferring its interest in the Main Street loan (and, in the case of Main Street expansion loans, its existing interest in the underlying loans as well) until the earlier of (i) the maturity date of the Main Street loan and (i) the date neither the Main Street SPV nor a governmental assignee holds an interest in the loan.  The Eligible Lender may thus be required to continue to hold its position in the applicable facility even after the Main Street SPV transfers a portion of its interest to another lender, regardless of the actions (or inactions) taken by the Main Street SPV relating to the Main Street loan, including in a workout, restructuring, bankruptcy or other distressed situation.

The Fed explains in FAQ J.5 that it does not expect the Main Street SPV to use its elevation or transfer rights as a matter of course, even when the borrower is in distress.  Rather, Eligible Lenders are to follow market-standard workout processes and to exercise the same duty of care in approaching such proceedings as they would exercise if they retained a beneficial interest in the entire loan.  Further, the Fed expects that the Main Street SPV generally will not elevate and assign except in situations where (i) the economic interests of the Eligible Lender and the Main Street SPV are misaligned or (ii) the loan amount is relatively large in comparison to other loans in the Main Street SPV’s portfolio of participations.

Voting Rights Both Before and After Elevation

Critically, the Participation Agreement provides that the Eligible Lender retains sole authority to exercise all votes, rights, and remedies with respect to the Main Street loan, except specifically with respect to “Core Rights Acts.”  “Core Rights Acts” are defined to include (i) actions (or inactions) with respect to the Main Street loan which affect what is commonly thought of as “sacred rights”[3] and (ii) actions (or inactions) that affect specific concerns or features of the Main Street program.[4]  The scope of the Core Rights Acts is quite broad (certainly broader than the “sacred rights” that is the trigger for participant voting rights under the LSTA model participation agreement form referred to above), and Eligible Lenders and borrowers should be aware that obtaining the Main Street SPV’s consent to such actions (and inactions) may present both substantive and administrative challenges. 

The Fed observes that “the Main Street SPV will make commercially reasonable decisions to protect taxpayers from losses on Main Street loans and will not be influenced by non-economic factors when exercising its voting rights….”[5]  While the Main Street SPV’s and Eligible Lender’s economic interests should be generally aligned, we anticipate that the Main Street SPV’s decisions regarding Core Rights Act will not always result in the outcome preferred by Eligible Lenders.  For instance, the Eligible Lender may be less reluctant than the Main Street SPV to postpone payment or write off some portion, of the loan as part of a work-out.  We would also expect that an Eligible Lender with other exposure to the Eligible Borrower or its affiliates might take a different view of its overall economic relationship with such entities than would the Main Street SPV or another governmental transferee.

After an elevation occurs, the Main Street SPV’s voting rights will be governed by: (i) for bilateral Main Street loans, the Co-Lender Agreement, and (ii) for multi-lender Main Street loans or “Expanded” facilities, the underlying loan documents.  Under the Co-Lender Agreement, amendments and waivers require the consent of the “Required Lenders,”[6] unless such amendments or waivers are with respect to actions (or inactions) comprising “Core Rights Acts”, in which case the consent of all lenders or all impacted lenders is required. 

Note that as the Main Street SPV or its assignees will hold 95% of the Main Street loan after elevation, they will be in control of all actions (or inactions) requiring the consent of the Required Lenders, leaving the Eligible Lender in a minority position with no blocking right other than in matters comprising Core Rights Acts or otherwise requiring the vote of the affected lender.  This may not be the result expected by Eligible Lenders as “club” deals sometimes require the consent of at least two non-affiliated lenders when the consent of Required Lenders is needed.  With respect to multi-lender Main Street facilities (in particular, “Expanded” loans), the Main Street SPV’s voting rights will be guided by the provisions in the underlying loan documents, so we would expect those rights to follow market standards.

FOOTNOTES

[1] Please see our comparative and annotated chart of the Main Street Loans here.

[2] “Loan Forgiveness” is defined as any reduction of the principal amount of the Main Street loan or other action or arrangement that, in the good faith determination of the Main Street SPV, could reasonably be expected to result in violation of the prohibition on loan forgiveness set forth in Section 4003(d)(3) of the CARES Act.  Loan Forgiveness does not include the addition of higher priority “priming” liens in a bankruptcy proceeding, reductions in interest, including any PIK interest, and extensions of amortization schedules and maturity dates.

[3] Such “sacred rights” include the (i) extension, increase or reinstatement of any commitment to a loan, (ii) reduction in principal, interest or other amounts payable in respect of a loan, (iii) delay or postponement of any scheduled payment of principal, interest or other amounts under a loan, (iv) altering of provisions dealing with pro-rata sharing or the application of proceeds, (v) release of all or substantially all of the collateral or value of guarantees, and (vi) waiver of conditions precedent to closing, effectiveness or funding.

[4] Including: (i) changes to the lender voting approval level with respect to any Core Rights Act, (ii) departures from any provision relating to certain certifications the borrower is required to make in the Main Street program documents, (iii) departures (other than a temporary delay) from any provision requiring the periodic financial reporting by the borrower, (iv) express subordination of the Main Street loan or any security interest in all or substantially all of the collateral therefor, and (v) failure to accelerate and exercise remedies with respect to the Main Street loan upon a Seller Debt Cross-Acceleration (defined as cross-acceleration upon a default under other indebtedness owed by the borrower to the Eligible Lender).

[5] FAQ J.6

[6] “Required Lenders” is defined to mean lenders holding more than 50% of the total credit exposure.

Copyright © 2021, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume X, Number 189

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Generic drugs

How generic drugs can help you save money on your prescriptions

by Joan J. Dean on

If you’re looking for ways to cut your health care costs, think about what you pay for your prescription drugs.

As prescription drug prices fluctuate constantly, a 2019 U.S. Food and Drug Administration (FDA) report says generic drugs can save you up to 79% compared to their branded equivalents .

How generic drugs can help you save on healthcare costs

Money expert Clark Howard is a big fan of paying as little as possible for your prescription drugs. In this article, I’ll show you why generic drugs are usually the cheapest option and how you can save money using them.

What are generic drugs?

Generic drugs are drugs that are manufactured to be equivalent to brand name drugs in key areas such as performance, safety, and intended use.

Before reaching stores and pharmacies, generic drugs must meet a string of rigorous standards, according to the FDA. Here are a few:

  • The active ingredient must be the same as the brand name drug.
  • The drug should have the same application.
  • The drug must match the brand name in terms of product type (tablet or injection) and strength.

The FDA website has a list of prescription approved generic drugs. Let’s take a look at some of the most popular. I’ve also added some conditions the drugs are used for, according to GoodRx.

Final Thoughts

The best way to find out if there is a generic drug you can use instead of a brand name is to simply ask a pharmacist.

Clark suggests that you partner with your doctor to find cheaper alternatives to the brand-name prescription drugs he might want to prescribe.

“Doctors have no idea of ​​the cost of prescriptions. So a doctor will write a prescription based on what they think is best for you,” says Clark. “But maybe you can find something just as good that, instead of costing $100, will cost you $4. That’s a big difference!

If you need to look up prescription drugs, check out the list of FDA-approved drugs.

If you can’t use generics or are just looking for other ways to save on your prescriptions, read the Clark team guide.

More healthcare resources on Clark.com:

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Generic drugs

Distorted Incentives Harm Medicare Patients

by Joan J. Dean on

This week, as the House Energy and Commerce Committee hearings on drug pricing reform unfold, it’s important to remind observers that how health plans and drug benefit managers structure drug benefits can have such a negative impact on beneficiary spending as high introductory prices for new pharmaceuticals and rising list prices for existing drugs.

Earlier this year, Avalere released a major data analysis that shows that this year Medicare Part D (outpatient) plans place generic prescription drugs on generic tiers with low cost sharing for the patient only 45% of the weather. This represents a decrease of almost 20% since 2016, when 64% of generic drugs were allocated to the lowest levels of the formulary.

Last year marked the first time since the 2006 launch of the Medicare Part D program that generics were placed more often on the nongeneric tiers than on the generic tiers.

The gap between the level of patient cost sharing for branded versus generic products has narrowed and in some cases disappeared. Skewed incentives imply higher additional costs for Medicare beneficiaries who take generic drugs.

According to Medicare Part D benefit design requirements, all Medicare plans must cover a wide range of pharmaceuticals, including virtually all Food and Drug Administration-approved drugs in six protected classes, such as drugs to treat cancer and HIV/AIDS. Additionally, all Medicare Part D plans must cover at least two drugs per therapeutic class, as defined by the United States Pharmacopeia.

Each health insurance plan – whether a stand-alone drug benefit or an integrated one, offering all health care benefits in one package – has its own formulary. Medicare Part D and Medicare Advantage plans assign drugs to different levels called “tiers” on their formularies. Each level has a different level of cost sharing for Medicare beneficiaries.

Traditionally, plans have placed prescription drugs in the following tiers:

  • Tier 1 – lowest cost sharing: This includes most generic prescription drugs.
  • Tier 2 – Medium Cost Share: This includes preferred brand name prescription drugs.
  • Tier 3 – higher cost sharing: This includes non-preferred brand name prescription drugs.
  • Specialty Level – Highest Cost Share: This includes high cost prescription drugs, such as many biologics.

Patient co-payments are increasingly taking the form of variable coinsurance rather than a fixed co-payment. Coinsurance is calculated as a percentage of the list price of a drug. The higher the formulary level and list price of a drug, the higher the out-of-pocket costs. And while list prices for drugs have risen dramatically in recent years, net prices — after rebates and other discounts — have stagnated and, in some cases, fallen. So the problem for payees is that they’re stuck with a disbursement tab that’s based on list prices, and they don’t see the discounts being passed to them at the pharmacy, at the point of sale.

Additionally, Avalere’s study shows that the typical tiered generic drug placement changes quite dramatically. The conventional designation of most generic prescription drugs at the lowest cost-share level no longer applies.

According to the Centers for Medicare and Medicaid Services (CMS), the decision in 2017 to allow Medicare plans to replace the “brand non-preferred” tier with a “non-preferred drug tier,” thereby increasing the proportion of generic drugs on the unprivileged component was intended to provide plans with greater flexibility in designing their benefits.

In 2017, CMS said it expected “the new non-preferred drug tier will likely contain a greater proportion of generic drugs than the current non-preferred brand tier composition.” At the same time, CMS encouraged “Part D sponsors to consider using coinsurance for the non-preferred level of medication instead of a co-payment.”

Essentially, CMS gave the plans leeway to shift costs onto patients. Here, flexibility is a code word for cost shifting. Increasingly, Part D plans are using coinsurance rather than co-payments to share patient costs of branded and generic products. This often involves a higher cost sharing for the patient as coinsurance is usually higher than user fees.

And unlike most commercial health insurers, Part D drug plans don’t cap patients’ 5% coinsurance charges once they hit the $8,140 catastrophic threshold.

As a result, some Medicare beneficiaries can pay thousands of dollars out of pocket for higher-level drugs, which now include an increasing number of generic (specialty) products.

From the outset, the Medicare Part D benefit structure was flawed. While several gaps in Part D benefit phase coverage have been filled, specialty generics have not gained the kind of traction that one might expect. The convoluted structure of Medicare Part D drug coverage means that beneficiaries often spend more out of pocket on certain specialty generic drugs than their brand-name counterparts.

As Medicare Part D plans increasingly place generic drugs on higher formulary levels and the benefit structure itself often favors brand name products, this in turn implies higher unwarranted costs. for Medicare beneficiaries who are prescribed generic drugs.

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Generic drugs

Generic drugs a great alternative to brand names for hypertension

by Joan J. Dean on

Generic blood pressure medications may be as effective as their brand name counterparts in lowering long-term blood pressure, study shows. Credit: Chinese Medical Journal

Hypertension is a common medical condition and one of the leading causes of cardiovascular disease and stroke worldwide. Unfortunately, as Professor Wei-Li Zhang of China’s National Center for Cardiovascular Disease notes, “the affordability of drugs is a major barrier to medication adherence among patients living in low- and middle-income areas.”

One of the countries where hypertension is becoming a major problem is China where, according to researchers’ estimates, between 244 and 300 million adults suffer from hypertension. But true to Professor Zhang’s words, most hypertension cases in China are not sufficiently controlled, and patients seeking treatment for hypertension have to pay for outpatient clinic visits and drug costs out of pocket. .

An emerging option to control the costs of antihypertensive drug therapy is to prescribe generic drugs, which contain the same active ingredients as their brand name counterparts, but cost significantly less. Several countries have taken steps to encourage the prescription of generic drugs as a means of reducing healthcare costs and enabling more patients, but some clinicians have reservations about prescribing generics due to fear that these drugs will not may not be as effective as their branded counterparts. A team of researchers led by Professor Zhang therefore decided to carry out a survey to find out whether generic antihypertensive drugs are as effective as branded drugs in controlling blood pressure in the long term. Their findings appear in an article recently published in Chinese medical journal.

In their study, they analyzed data from a cohort study of patients with hypertension conducted in 18 hospitals in 12 Chinese provinces. Baseline screenings took place between 2013 and 2015, and follow-up assessments continued through August 1, 2017. Researchers focused on 2,176 study participants who were using brand-name blood pressure medications and 4,352 participants who used generic drugs. They performed statistical analyzes to compare the two groups in terms of changes in blood pressure over the follow-up period.

They found that generic drugs were just as effective as brand name drugs in lowering blood pressure. Between the group using generic drugs and the group using brand name drugs, the percentages of patients who achieved well-controlled blood pressure levels (defined here as systolic blood pressures below 140 mmHg and diastolic blood pressures below 90 mmHg) and the odds of experiencing adverse cardiovascular outcomes, such as coronary heart disease and stroke, were similar. After adjusting for age, sex, body mass index values, number of antihypertensive drugs taken, and traditional cardiovascular risk factors, the mean reduction in systolic blood pressure was 7.9 mmHg for participants who were taking brand name drugs and 7.1 mmHg for participants who were taking generic drugs.

However, some differences in the results emerged when the researchers looked at specific subgroups of participants. Among participants younger than 60, those taking brand name drugs were more likely to achieve well-controlled blood pressure levels than their counterparts taking generic drugs. A similar difference between brand name and generic drugs emerged when the researchers limited their analyzes to men with high blood pressure.

Despite the differences seen in the subgroup analyses, the results provide overall strong evidence that generic drugs are just as effective as brand name drugs in lowering blood pressure levels. It is important to note that generic drugs achieve these effects at a much lower cost; a 1 mmHg reduction in systolic blood pressure was found to be US$315.40 cheaper with generic drugs than with brand name drugs. This cost difference means that treatment with generic drugs is half the cost of treatment with branded drugs, and it will undoubtedly mean a lot to the many people in China and beyond who live on low to means.

That’s why Professor Zhang expresses hope that these findings will give “an impetus to doctors and patients to preferentially use generic drugs instead of expensive brand name drugs to lower blood pressure levels.” By expanding access to antihypertensive treatment, the use of generic drugs will bring significant public health benefits in China and other developing countries.

Claims for brand names instead of generic prescription drugs cost the Medicare program $1.7 billion in a single year

More information:
Shu-Yuan Zhang et al, Evaluation of blood pressure lowering effect by treatment of generic and branded antihypertensive drugs, Chinese medical journal (2021). DOI: 10.1097/CM9.0000000000001360

Provided by Chinese Medical Journal

Quote: Cheap but desirable: Generic drugs are a great alternative to brand names for hypertension (2021, May 4) retrieved July 4, 2022 from https://medicalxpress.com/news/2021-05-cheap-desirable -drugs-great-alternative.html

This document is subject to copyright. Except for fair use for purposes of private study or research, no part may be reproduced without written permission. The content is provided for information only.

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Generic drugs

Cheap but desirable: Generic drugs are a great al

by Joan J. Dean on

image: Generic blood pressure medications may be as effective as their branded counterparts in lowering long-term blood pressure, study shows
to see After

Credit: Chinese Medical Journal

Hypertension is a common medical condition and one of the leading causes of cardiovascular disease and stroke worldwide. Unfortunately, as Professor Wei-Li Zhang of China’s National Center for Cardiovascular Disease notes, “the affordability of drugs is a major barrier to medication adherence among patients living in low- and middle-income areas.”

One of the countries where hypertension is becoming a major problem is China where, according to researchers’ estimates, between 244 and 300 million adults suffer from hypertension. But true to Professor Zhang’s words, most hypertension cases in China are not sufficiently controlled, and patients seeking treatment for hypertension have to pay for outpatient clinic visits and drug costs out of pocket. .

An emerging option to control the costs of antihypertensive drug therapy is to prescribe generic drugs, which contain the same active ingredients as their brand name counterparts, but cost significantly less. Several countries have taken steps to encourage the prescription of generic drugs as a means of reducing healthcare costs and enabling more patients, but some clinicians have reservations about prescribing generics due to fear that these drugs will not may not be as effective as their branded counterparts. A team of researchers led by Professor Zhang therefore decided to carry out a survey to find out whether generic antihypertensive drugs are as effective as branded drugs in controlling blood pressure in the long term. Their findings appear in an article recently published in Chinese medical journal.

In their study, they analyzed data from a cohort study of patients with hypertension conducted in 18 hospitals in 12 Chinese provinces. Baseline screenings took place between 2013 and 2015, and follow-up assessments continued through August 1, 2017. Researchers focused on 2,176 study participants who were using brand-name blood pressure medications and 4,352 participants who used generic drugs. They performed statistical analyzes to compare the two groups in terms of changes in blood pressure over the follow-up period.

They found that generic drugs were just as effective as brand name drugs in lowering blood pressure. Between the group using generic drugs and the group using brand name drugs, the percentages of patients who achieved well-controlled blood pressure levels (defined here as systolic blood pressures below 140 mmHg and diastolic blood pressures below 90 mmHg) and the odds of experiencing adverse cardiovascular outcomes, such as coronary heart disease and stroke, were similar. After adjusting for age, gender, body mass index values, number of antihypertensive drugs taken, and traditional cardiovascular risk factors, the mean reduction in systolic blood pressure was 7.9 mmHg for participants who were taking brand name drugs and 7.1 mmHg for participants who were taking generic drugs.

However, some differences in the results emerged when the researchers looked at specific subgroups of participants. Among participants younger than 60, those taking brand name drugs were more likely to achieve well-controlled blood pressure levels than their counterparts taking generic drugs. A similar difference between brand name and generic drugs emerged when the researchers limited their analyzes to men with high blood pressure.

Despite the differences seen in the subgroup analyses, the results provide overall strong evidence that generic drugs are just as effective as brand name drugs in lowering blood pressure levels. It is important to note that generic drugs achieve these effects at a much lower cost; a 1 mmHg reduction in systolic blood pressure was found to be US$315.40 cheaper with generic drugs than with brand name drugs. This cost difference means that treatment with generic drugs is half the cost of treatment with branded drugs, and it will no doubt mean a lot to the many people in China and beyond who live on low to means.

That’s why Professor Zhang expresses hope that these findings will give “an impetus to doctors and patients to preferentially use generic drugs instead of expensive brand name drugs to lower blood pressure levels.” By expanding access to antihypertensive treatment, the use of generic drugs will bring significant public health benefits in China and other developing countries.

###

Reference


Titles of the original articles: Evaluation of the blood pressure lowering effect of treatment with generic and branded antihypertensive drugs: a multicenter prospective study in China

Log: Chinese medical journal

DOI: 10.1097/CM9.0000000000001360

Log

Chinese medical journal

Warning: AAAS and EurekAlert! are not responsible for the accuracy of press releases posted on EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Generic drugs

U.S. Generic Drugs Market Report 2021: The Market

by Joan J. Dean on

Dublin, April 28, 2021 (GLOBE NEWSWIRE) — The report “Generic Drugs Market in the United States by Segment (Generic, Branded), Therapeutic Application, Company Analysis and Forecast” has been added to from ResearchAndMarkets.com offer.

The US generic drug market will reach US$239.5 billion by 2026.

Generics are an off-patent drug that is the pharmaceutical equivalent of brand name drugs in terms of administrative dosage, quality, effect, intended use, and side effects. In the United States, the production of generic drugs has increased because they are cheaper than any brand name drug. Over the past 3 decades, the US generic drug market has grown from less than 20% of generic drug prescriptions to 80% of generic drug prescriptions.

Generic drugs help sustain the country’s healthcare system, from curing patients to saving money. Currently, the price of off-label drugs is 70 to 80% lower than that of brand name drugs. In the United States, the decline in the price of drugs is the main catalyst for the growth of the generic drugs market. The prices of these generic drugs have sometimes dropped up to 85% less than the patented drugs; this happens when various generic drug companies target a single patented drug. the research findings suggest that the US off-label drug market will grow with a CAGR of 5.69% in the future from 2020 to 2026.

The United States government’s awareness of the use of generic drugs is reducing overall healthcare expenditures in the country. The FDA’s Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures Americans have access to safe, high-quality, and affordable drugs. The US government has passed a generic drug law, allowing a new player to enter the market. Besides factors such as increasing number of patients with diabetes, Alzheimer’s, heart disease, growing number of drug patent expirations and government initiatives that are expected to boost the generic drug industry.

According to this research study, the US off-patent drug market was US$171.8 billion in 2020.

Offers from generic drug manufacturers

On July 6, 2020, Endo announced that it had received FDA approval for Qwo (collagenase clostridium histolyticum-aaes). Another company, named Lupine Limited, manufactures the generic drug Abacavir & Lamivudine, the combination of which is used with other drugs to treat Human Immunodeficiency Virus (HIV) infection. The editor covered the initiatives of companies that sell various generic drugs in the United States.

Companies covered in the report are Teva Pharmaceutical Industries Ltd, Mylan NV, Sandoz Inc, Endo Pharmaceuticals, Lupine Limited, Dr Reddy’s and Sun pharma.

Main topics covered:

1. Introduction

2. Executive Summary

3. Market dynamics
3.1 Engine of growth
3.2 Challenges

4. Drug market in the United States
4.1 Branded Drugs Market
4.2 Generic Drugs Market

5. Generic drug economy in the United States

6. Market Share – Drug Analysis in United States
6.1 Branded drugs vs. generic drugs
6.2 Branded Generic Drug vs Non-Branded Generic Drug
6.3 Volume Penetration – Generic and Branded Drugs
6.4 Therapeutic application

7. Generic Drugs Market in United States
7.1 Branded Generic Drugs Market
7.2 Non-Branded Generic Drugs Market

8. Therapeutic Application – Generic Drugs Market in United States
8.1 Central Nervous System (CNS)
8.2 Cardiovascular
8.3 Dermatology
8.4 Genitourinary/hormonal drugs
8.5 Respiratory
8.6 Anti-infectives
8.7 Oncology
8.8 Others

9. Business Analysis
9.1 Overview
9.2 Product launch
9.3 Financial overview

  • Teva Pharmaceutical Industries Ltd
  • Mylan AG
  • Sandoz inc.
  • Endo Pharmaceuticals
  • Lupine Limited
  • at Dr. Reddy’s
  • Solar pharmacy

For more information about this report visit https://www.researchandmarkets.com/r/o88uql


        



		
		
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Generic drugs
		
Global Generic Drugs Market (2021 to 2026)
		

	by
	
	Joan J. Dean	


	on
	



					
			

	

		

			
									

					

	


DUBLIN, April 16, 2021 /PRNewswire/ — The report “Generic Drug Market: Global Industry Trends, Share, Size, Growth, Opportunities and Forecast 2021-2026” has been added to from ResearchAndMarkets.com offer. 


The global generic drug market reached a value of US$386 billion in 2020. A generic drug is a drug that contains the same active ingredient and has an equivalent therapeutic effect to the brand name drug.  It is also identical in terms of safety, quality, dosage, strength, route of administration, intended use, effect, form, quality, and side effects.  These drugs can only be produced after the brand name drug’s patent expires.  Compared to branded drugs, the production of generics is much cheaper because it does not require repeated clinical (human) and animal studies to demonstrate the effectiveness and safety of the drug.  Due to a reduction in the initial cost of research, generics are generally sold at a significantly lower price in the market.


Market trends:


Due to the aging of the population and the increasing incidence of chronic diseases, governments in developed countries have made efforts to reduce health care costs by encouraging the production of generics.  Whereas, in developing countries, affordability and accessibility are some of the major issues facing the healthcare sector.  To address these issues, governments and other regulatory bodies have encouraged manufacturers to introduce effective generic drugs.  However, despite the rapid expiration of patents on branded drugs, there has been a shortage of generics.  This situation is currently being corrected by various initiatives taken by hospitals, institutions and other organizations around the world.


For example, in 2018, a coalition of seven hospitals and three philanthropic organizations in the United States announced that they would tackle drug shortages and the high cost of essential drugs by launching a generic drug company, named Civica Rx. .  The company has been producing 14 FDA-approved drugs available in the market since the beginning of 2019. Apart from that, in 2018, the United States Food and Drug Administration (USFDA) created policies to make the process of l market entry and approval of more effective generics.  It has published guidance documents for the development of hard-to-copy drug classes and specific complex drugs.  Looking ahead, the publisher expects the global generic drug market to show moderate growth over the next five years.


Competitive Landscape:


The market is fragmented in nature with the presence of various small and large manufacturers.  Some of the major players operating in the market include Teva Pharmaceuticals Industries Ltd., Mylan NV, Novartis AG, Pfizer Inc., Sun Pharmaceutical Industries Ltd., Fresenius SE & Co., Lupine Limited, Endo Pharmaceuticals Inc., Aurobindo Pharma Limited, and Aspen Pharmacare Holdings Limited.


Answers to key questions in this report:


    

  • How has the market behaved so far and how will it behave in the years to come? 
    • 

  • What are the main regional markets? 
    • 

  • What has been the impact of COVID-19 on the global generic drugs market? 
    • 

  • What are the main drug distribution segments? 
    • 

  • What are the main therapeutic areas? 
    • 

  • What are the main distribution channels? 
    • 

  • What are the different stages of the industry value chain? 
    • 

  • What are the key drivers and challenges in the industry? 
    • 

  • What is the structure of the industry and who are the main players? 
    • 

  • How competitive is the industry? 
    • 

  • What are the profit margins in the industry? 
    • 

  • What are the main requirements for setting up a manufacturing plant? 
    • 

  • How are generic drugs made? 
    • 

  • What are the different unit operations involved in a manufacturing plant? 
    • 

  • What is the total area of ​​land needed to set up a manufacturing plant? 
    • 

  • What are the machinery requirements for setting up a manufacturing plant? 
    • 

  • What are the raw material requirements for setting up a manufacturing plant? 
    • 

  • What are the packaging requirements for generic drugs? 
    • 

  • What are the transportation requirements for generic drugs? 
    • 

  • What are the utility requirements for setting up a manufacturing plant? 
    • 

  • What are the labor requirements for setting up a manufacturing plant? 
    • 

  • What are the infrastructure costs for setting up a manufacturing plant? 
    • 

  • What are the investment costs for setting up a manufacturing plant? 
    • 

  • What are the operating costs for setting up a manufacturing plant? 
    • 

  • What will be the income and expenses of a manufacturing plant? 
    • 

  • How long does it take to break even?
    • 



Main topics covered: 


1 Preface


2 Scope and methodology
2.1 Objectives of the study
2.2 Stakeholders
2.3 Data sources
2.3.1 Primary sources
2.3.2 Secondary sources
2.4 Market Estimation
2.4.1 Bottom-up approach
2.4.2 Top-down approach
2.5 Forecasting methodology


3 Executive summary


4 Presentation
4.1 Overview
4.2 Key Industry Trends


5 Global Generic Drug Industry
5.1 Market Overview
5.2 Market Performance 
5.3 Impact of COVID-19
5.4 Market Breakdown by Country
5.5 Market Breakdown by Therapeutic Area
5.6 Market Breakdown by Drug Delivery
5.7 Market Breakdown by Distribution Channel
5.8 Market Forecast 
5.9 SWOT Analysis
5.9.1 Preview
5.9.2 Strengths
5.9.3 Weaknesses
5.9.4 Opportunities
5.9.5 Threats
5.10 Value chain analysis
5.10.1 Research and development
5.10.2 Manufacturing
5.10.3 Marketing and distribution
5.11 Porter’s Five Forces Analysis
5.11.1 Presentation
5.11.2 Bargaining power of buyers
5.11.3 Bargaining power of suppliers
5.11.4 Degree of competition
5.11.5 Threat of new entrants
5.11.6 Threat of Substitutes
5.12 Regulation in the generic industry
5.13 Key Market Drivers and Success Factors


6 Performance of key countries
6.1 United States
6.1.1 Market trends
6.1.2 Market Forecast
6.2 China
6.2.1 Market trends
6.2.2 Market Forecast
6.3 Brazil
6.3.1 Market trends
6.3.2 Market Forecast
6.4 Germany
6.4.1 Market trends
6.4.2 Market Forecast
6.5 France
6.5.1 Market trends
6.5.2 Market Forecast
6.6 India
6.6.1 Market trends
6.6.2 Market Forecast
6.7 UK
6.7.1 Market trends
6.7.2 Market Forecast
6.8 Japan
6.8.1 Market trends
6.8.2 Market Forecast
6.9 Canada
6.9.1 Market trends
6.9.2 Market Forecast
6.10 Italy
6.10.1 Market trends
6.10.2 Market Forecast
6.11 Others
6.11.1 Market trends
6.11.2 Market Forecast


7 Market Breakdown by Therapeutic Area
7.1 Central nervous system
7.1.1 Market trends
7.1.2 Market Forecast
7.2 Cardiovascular
7.2.1 Market trends
7.2.2 Market Forecast
7.3 Dermatology
7.3.1 Market trends
7.3.2 Market Forecast
7.4 Genitourinary/Hormonal
7.4.1 Market trends
7.4.2 Market Forecast 
7.5 Respiratory
7.5.1 Market trends
7.5.2 Market Forecast 
7.6 Rheumatology 
7.6.1 Market trends
7.6.2 Market Forecast 
7.7 Diabetes
7.7.1 Market trends
7.7.2 Market Forecast
7.8 Oncology
7.8.1 Market trends
7.8.2 Market Forecast
7.9 Others
7.9.1 Market trends
7.9.2 Market Forecast


8 Market Breakdown by Drug Delivery
8.1 Oral
8.1.1 Market trends
8.1.2 Market Forecast
8.2 Injectables 
8.2.1 Market trends
8.2.2 Market Forecast
8.3 Dermal/Topical
8.3.1 Market trends
8.3.2 Market Forecast
8.4 Inhalers
8.4.1 Market trends
8.4.2 Market Forecast


9 Market Breakdown by Distribution Channel
9.1 Retail pharmacies
9.1.1 Market trends
9.1.2 Market Forecast
9.2 Hospital pharmacies
9.2.1 Market trends
9.2.2 Market Forecast


10 Competitive Landscape
10.1 Competitive Structure
10.2 Market Breakdown by Major Players
10.3 Key Player Profiles
10.3.1 Teva Pharmaceuticals Industries Ltd.
10.3.2 Mylan SA
10.3.3 Novartis AG
10.3.4 Pfizer Inc.
10.3.5 Sun Pharmaceutical Industries Ltd.
10.3.6 Fresenius SE & Co.
10.3.7 Lupine Limited
10.3.8 Endo Pharmaceuticals Inc.
10.3.9 Aurobindo Pharma Limited
10.3.10 Aspen Pharmacare Holdings Limited


11 Generic drug manufacturing process
11.1 Product Overview
11.2 Detailed process flow (tablets)
11.3 Detailed process flow (injectable)
11.4 Various types of unit operations involved
11.5 Mass balance and raw material requirements


12 Project details, requirements and costs involved
12.1 Land Requirements and Expenditures
12.2 Construction Requirements and Expenses
12.3 Plant machinery
12.4 Images of machines
12.5 Raw Material Requirements and Expenditures
12.6 Packaging Requirements and Expenses
12.7 Transportation Requirements and Expenses
12.8 Utility Requirements and Expenses
12.9 Labor Requirements and Expenditures
12.10 Other capital investments


13 Loans and Financial Aid


14 Economics of the project
14.1 Capital cost of the project
14.2 Technical and economic parameters
14.3 Product Pricing and Margins at Different Levels of the Supply Chain
14.4 Taxation and depreciation
14.5 Revenue projections
14.6 Expenditure Projections
14.7 Financial analysis
14.8 Profit Analysis


For more information about this report visit https://www.researchandmarkets.com/r/cmoi5i


Media Contact:


Research and Markets 
Laura Woodsenior 
[email protected] 


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Generic drugs
		
[Startup Bharat] With generic drugs, Medkart, based in Ahmedabad, aims to reduce your medical bills
		

	by
	
	Joan J. Dean	


	on
	



					
			

	

		

			
									

					

	


A move to help people lower their medical bills by allowing access to generic versions of expensive branded drugs led Ankur Agarwal to establish Medkart Pharmacy in Ahmedabad along with Parasharan Chari and Parthiv Shah.


The medtech startup was created in September 2014 to promote inexpensive generic medicines certified by the World Health Organization’s Good Medical Practices (WHO GMP) and make them available to patients. 




Ankur says people can reduce their medical bills by 60-70% by buying generic drugs from Medkart’s chain of over 70 stores in Gujarat including places like Mahuva, Navsari, Ahmedabad, Vadodara, Surat, Jamnagar, Valsad and Silvassa.


According to experts, many drugs available in India are generic versions manufactured at low prices, but the cost advantage does not reach the buyer as big pharmaceutical companies sell them at high prices.


A generic drug is a drug that has the same dosage, safety, strength, route of administration, quality, performance characteristics, and intended use as an already marketed brand name drug.  Since a generic drug is not a new drug, manufacturers do not have to incur the expense of developing and marketing it.  they can seek permission to manufacture and sell generic versions when the drug’s patent expires.




The eureka moment


What sparked Ankur’s interest in generic drugs was his father-in-law’s dialysis treatment following surgery in December 2013 that required him to take an injection costing 1,300 rupees a week for a year – an expensive affair. 


“After a few doses were given, I searched for the particular injection in Ahmedabad and found that some people were willing to sell them at Rs 800-900,” says Ankur.  “These cheaper injections had the same content and the same molecules as the one prescribed, but since they were generic, their prices were almost half.  That’s when I found out about generic drug channels and decided to find out more about them.  » 




He learned that if the injections were purchased in bulk, the cost could be less than half. 


Initially, Ankur had planned to launch an e-pharmacy.  But “it was not easy to explain cheaper substitutes to consumers;  it was a time-consuming process,” he says. 


At that time, Ankur was the CFO of the education company Endeavour, where Parasharan served as COO.  Their common connection, Parthiv, had worked in the pharmaceutical industry for a decade and had experience and knowledge of its various aspects.  It wasn’t long before they teamed up to launch Medkart in 2014. Parasharan joined the startup full-time three years after it was incorporated and helped grow the brand. 


  


Now, Medkart sells generic versions of the injection which was prescribed to Ankur’s father-in-law at Rs 300.


Ankur and Parasharan have been colleagues for about 13 years now and know each other’s working style as they were in the same strategic teams in their previous projects. 


“The process of finding co-founders was smooth because we all have a common vision, which is to make generic drugs available at the best price and to educate customers to buy smart and right,” says Ankur.




Currently, Medkart is managed by a team of 275 people.


Understand the market 


Parasharan says that after the formation of Medkart, as founders, they tried to understand how people bought drugs. 


“Generally, retail stores sell the same brand of medication as prescribed by the doctor,” he says.  “The difference we try to make is by checking if there are other branded drugs with the same molecules. After checking, we offer the best deals possible and try to ensure that the quality is not compromised and that the drugs are approved by the WHO.




For example, if a customer has a prescription that has a few brand name drugs listed, Medkart tries to inform them of other available drugs that are of the same quality and are cheaper, he explains. 


“Drugs available at a lower price come from GMP-approved brands, which means they will have similar standards across the country,” he adds. 


Some of the companies that work in the same field as MedKart are Generico, Dava India and Generic Aadhaar funded by Ratan Tata.


“But no brand can match the services provided by Medkart and there is no direct competition,” says Ankur.




 


The startup has physical stores and also uses an omnichannel approach, in which customers in Gujarat can check on its mobile app for drug availability and place orders for delivery.


Ankur says Medkart caters to around one lakh customers every month and recorded revenue of Rs 60 crore for FY21.  According to the startup, its low-cost generic drugs have so far saved customers a total of Rs 1,100 crore.


Focus on greater penetration


Medkart has been started so far with funds from family and friends.  The initial seed capital of Rs 20 lakh was used to set up the first store and fund the back-end operations. 


The startup is in talks with strategic investors and plans to increase its number of stores to over 250 in Gujarat over the next 18 months.





		
		
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Generic drugs
		
The market value of generic drugs is expected to reach 627.6 USD
		

	by
	
	Joan J. Dean	


	on
	



					
			

	

		

			
									

					

	


Acumen Research and Consulting, a global market research provider, in a recently released report titled “Generic Drugs Market – Global Industry Analysis, Market Size, Opportunities and Forecast, 2020-2027 »


LOS ANGELES, April 01, 2021 (GLOBE NEWSWIRE) — The Global Generic Drugs Market is expected to grow at a CAGR of around 11.1% over the forecast period 2020 to 2027 and reach around US$627.6 billion by 2027. 


Rising generic drug R&D activities and increasing healthcare expenditure are major factors that are expected to drive the growth of the global generic drug market.


The North America market is expected to account for a major revenue share in the global generic drugs market owing to the availability of advanced healthcare infrastructure.  The increasing number of patients with chronic diseases and the government is focused on reducing the cost of health care for consumers.  It spends a lot on the development and promotion of generic drugs.  Generic drugs generated $253 billion in savings for patients and taxpayers in 2016. Over the past decade, the US healthcare system has saved $1.67 trillion through the availability of low-cost generics .  Savings for the two largest government health care programs, Medicare and Medicaid, totaled US$77 billion and US$37.9 billion, respectively in 2016.


DOWNLOAD SAMPLE PAGES FROM THIS [email protected] https://www.acumenresearchandconsulting.com/request-sample/2538


This means that each Medicare enrollee saved an average of $1,883, while each Medicaid enrollee saved an average of $512.  US regulators are focused on bringing safe, effective, and high-quality generic alternatives to market, creating more affordable treatment options for patients.  The introduction of innovative drugs by the players is expected to support the growth of the regional generic drugs market. 


In 2021, Ajanta Pharma Limited, a drug manufacturing company, received approval for ‘Northera (Droxidopa) Capsules’, a generic drug.  The drug is focused on the treatment of postural dizziness or lightheadedness in adult patients with symptomatic neurogenic postural hypotension. 


In 2021, Unichem Laboratories Limited, a generic drug manufacturing company, received approval for “Otezla (Apremilast) Tablets”, a generic drug.  The drug is intended for the treatment of adult patients with moderate to severe plaque psoriasis. 


The Asia-Pacific market is expected to witness faster growth in the generic drug market in the coming years owing to high government healthcare expenditure.  Key players’ approach to boosting business in emerging economies and focus on moving manufacturing units to developing countries for low-cost product development are factors that are expected to boost the growth of the drug market generics.  Further, the players are focusing on the strategic partnerships and agreements to strengthen the distribution channel is expected to support the growth of the target market.


SEE THE TABLE OF CONTENTS OF THIS [email protected] https://www.acumenresearchandconsulting.com/generic-drugs-market


The cost of branded drugs is skyrocketing while the rising cost of healthcare facilities is driving the demand for generic drugs, which is a major factor expected to drive the growth of the global generic drugs market.  Generic drugs are usually manufactured at a lower cost, which also reduces the price of the final product.  The increase in the number of people suffering from chronic illnesses and the high cost of drugs are having an impact on the patient care system.  Increasing government awareness activities regarding generic drugs among consumers and emphasis on strengthening the distribution channel are factors that are expected to impact the growth of the target market.


According to the Generic Pharmaceutical Association, generic drugs accounted for 88% of all prescriptions dispensed at retail in the United States in 2014, while consuming only 28% of total drug spending.  The use of generics, when available, is estimated to have saved the US healthcare system US$1.68 trillion between 2005 and 2014, including US$254 billion in 2014 alone.  The government’s emphasis on high spending on generic drug development and providing innovative drugs to consumers is expected to increase the growth of the target market.  Factors such as stringent government regulations related to product approval and adverse drug reactions are expected to hamper the growth of the global generic drugs market.


Also, the lack of consumer awareness of generic drugs is expected to challenge the growth of the target market.  However, high investments by major players, increase in clinical trial activities and growing demand for new generic drugs are factors that are expected to create new opportunities for players operating in the generic drugs market during the period. forecast.  Additionally, increasing number of licensing strategies and partnerships to launch new products is expected to support the target market revenue transaction.


Browse Upcoming Market Research Reports @ https://www.acumenresearchandconsulting.com/forthcoming-reports


The global generic drugs market is segmented into product type, application, route of administration and distribution channel.  The application segment is divided into cardiovascular products, anti-infective drugs, arthritis drugs, central nervous system drugs, cancer drugs, respiratory products and others.  Among the applications, the cancer drug is expected to grow faster in the generic drug market.


The distribution channel segment is divided into hospitals, pharmacies and others.  Among the distribution channels, the hospital segment is expected to account for a major share of revenue in the global market.  The players operating in the global generic drugs market are Abbott Laboratories, Teva Pharmaceutical Industries Ltd., ALLERGAN, Sandoz International GmbH, Mylan NV, STADA Arzneimittel AG, Baxter International Inc., Eli Lilly and Company, GlaxoSmithKline Plc.  and Pfizer Inc. The market is highly competitive owing to the presence of a large number of players operating globally.


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Medical products
		
Letter to suppliers of drugs and medical products
		

	by
	
	Joan J. Dean	


	on
	



					
			

	

		

			
									

					

	


Dear Colleague,


I am writing to share with you an important update on our collective work to help ensure continuity of supply of medicines and medical products in the UK.  This follows the Withdrawal Agreement negotiated between the Government and the EU and the UK-EU Trade and Cooperation Agreement (TCA) which came into force at the end of the period. (EoTP).


Maintain our working relationship


First of all, I would like to thank you for the continuous and crucial role you play in helping to ensure the continuity of supply to the health and care sector.  The past year has been extremely challenging due to the global impact of COVID-19 and we know that many of your supply chains were and remain under severe strain.


The ongoing pandemic and the return of planned and elective care in the NHS means we need to prepare thoroughly for the next phase of this process.  Risks remain over the next year, and we need to ensure our supply chains are resilient to these near-term challenges and co-develop long-term strategies to improve supply resilience for the benefit of patients.  Over the past 18 months, we have learned the importance of working together to build resilience in supply chains and we will continue to do so.


Maintain current levels of readiness


While there have been isolated, often complex disruption incidents since January 1, we have not seen the level of supply disruption that underpinned our planning assumptions.  Recognizing this as good news, the Department of Health and Social Care (the Department) is of the view that we need to maintain current levels of preparedness for a few more months as part of our goal common goal of ensuring patient safety through resilient supply chains.


There are existing challenges that need to be acknowledged, including the ongoing response to the coronavirus (COVID-19) pandemic, the growing third wave in Europe and its likely impact here in the UK.  There remains a residual risk of COVID-19 impacting global borders and, as we have seen over the past 12 months, the impact of this is difficult to anticipate and mitigate, although we will as far as possible.  For these reasons, the Department has requested NHS Supply Chain to maintain emergency stock for medical devices and clinical consumables in the Centralized Stock (CSB) for the foreseeable future, and we strongly encourage you to continue. to keep your inventory in the UK, where it was built and remains.


The department is committed to reviewing these emergency measures and reporting back to industry with recommendations after this review and over the summer.  This review will include a review of the CSB and our guidance to industry, taking into account the latest information as well as the COVID-19 situation and outlook.


Some of you have chosen to make your own EoTP upstream rerouting plans.  As part of the resilience of your supply chains, you may wish to continue to incorporate alternative logistics routes into your plans to ensure uninterrupted resupply to the UK.  The government will maintain the availability of Government Guaranteed Freight Capacity (GSFC) until the end of June.  Consult the list of critical goods that can be transported on GSFC.


The National Supply Disruption Response (NSDR) remains operational and available to support supply disruption cases.  Please see information on how to contact the NSDR.


Entry into force of import controls on October 1, 2021 and January 1, 2022


The staggered border controls originally scheduled for April 1 and July 1, 2021 have now been postponed to October 1, 2021 and January 1, 2022 respectively.  As the government has revised the timetable for introducing controls on imports from the EU into Great Britain (GB), it is crucial that you take advantage of this time to continue preparations in order to be ready. for the introduction of these checks.


Import controls are a general update of sanitary and phytosanitary (SPS) import requirements.  SPS measures include the requirement of prior notification to national authorities before importation of goods, health certification and entry of goods through a Border Control Post (BCP) equipped to handle the specific imported goods.  These changes will take place in 2 phases:


October 2021


From 1 October 2021, imports of all products of animal origin (POAO), certain animal by-products (ABP), plants and regulated plant products will require prior notification to the UK authorities via the import of products, animals, foodstuffs and animal feed.  (IPAFFS) and must be accompanied by correct medical documentation.  However, if your product has a license under the Medicines Act issued by the Medicines and Healthcare products Regulatory Agency (MHRA) or the Veterinary Medicines Directorate (VMD), or a CE mark, then the product is exempt from sanitary and phytosanitary (SPS) controls.  This applies to products that are not finished drugs, as finished drugs are not subject to SPS controls.


January 2022


Full UK import checks come into effect on 1 January 2022. Goods subject to SPS checks will need to pass through a designated BCP equipped to handle the goods in question and be subject to checks, with a list of BCP approved available.  Goods will be subject to an increased rate of physical checks.  This relates to applicable drugs, medical devices and any other category of healthcare supplies within the scope.


See more information on progressive border controls in October this year and January 2022. See information on the continuation of the arrangements for authorized movement to Northern Ireland (STAMNI) schemenow extended until at least October 1, 2021.


Regulation of medical devices


On May 26, 2021, medical device suppliers in Northern Ireland (and the EU) will need to comply with the Medical Devices Regulation (MDR).


MDR is not implemented in Great Britain, but, in accordance with the Northern Ireland Protocol, will be implemented in Northern Ireland (NI).  See more information about device regulations.


Drug Batch Testing


We have listened to industry concerns regarding the need for appropriate lead time to implement our future drug batch testing strategy.  The ATT includes significant facilitations with respect to medicines, including an agreement to recognize Good Manufacturing Practices (GMP) inspections and a working group on medical products.  The UK previously agreed to a 2-year unilateral recognition period of EU batch testing for a time-limited period, starting January 1, 2021.


We have since introduced a 2 year notice period for any changes to the current position of unilateral recognition of EU/European Economic Area (EEA) batch testing and will conduct a full review of the future batch testing strategy for the UK, in collaboration with industry.  and other stakeholders everywhere.  The 2-year notice period will be triggered once this review is completed, i.e. by the end of December 2022 at the latest.


This means that continued recognition of EU/EEA batch testing will not end on January 1, 2023.


While the notice period allows the sector to continue to focus on the pandemic and protect the supply of medicines for UK patients, the status quo policy in other areas has not changed.  We continue to encourage and support industry partners to prepare for the end of the status quo in all other areas later this year.


The MHRA has updated its guidance on batch testing to reflect the addition of the 2 year notice period.


Supply in NI from January 1, 2022


The department is aware of the challenges in supplying NI starting January 1, 2022. We are currently working with all partners to address these.


Report supply changes


Please stay in close contact with the department teams and report any supply issues, shortages or disruptions.


For drugs, this is done through the DASH (Discontinuations and Shortages) portal.  It is a legal requirement to notify the department of any perceived supply disruptions or shortages in any UK country (English, Scottish, Welsh and Northern Irish markets) via the DASH portal, although there remains a separate mailbox for EoTP-related returns or queries.


For medicines, medical devices, substances of human origin, non-clinical goods and services and supplies for clinical trials, please notify the relevant service teams via the mailboxes below.


Additional support


In addition to this letter and the continued engagement of DHSC teams, we will continue to host webinars to which you will be invited.  We also continue to encourage you to join our online platform DHSC eXchange, which now offers a wide range of supplier-relevant government content.  If you are not yet a member, you can request an invitation by emailing your usual contact or one of the teams at the email addresses above.


We continue to work hand in hand with the NHS, industry trade associations, devolved administrations, MHRA and other government departments on strengthening supply chains.



For more information on border and customs processes, visit www.gov.uk/transition.  All COVID-19 advice and advisories are available at www.gov.uk/coronavirus.  For GSFC specific questions, please contact [email protected]  You can follow these Twitter accounts to keep up to date:


Sincere friendships,


Steve Oldfield


Commercial director


Department of Health and Social Affairs





		
		
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Medical products
		
Guidance Document on Traceability of Medical Products
		

	by
	
	Joan J. Dean	


	on
	



					
			

	

		

			
									

					

	


Insight 


This guidance document describes the characteristics of existing traceability systems and provides guidance on developing viable traceability regulations.  Given the widely varying needs, capacities and resources of Member States, the risk mitigation and sustainability strategies incorporated into implementation efforts will vary.  Given the range of possible implementation pathways, a set of guiding principles will help Member States put in place the systems best suited to their needs and constraints.



To this end, Member States are encouraged to:



    

  • establish a suitable governance process for their traceability system based on the analysis of national specificities (e.g. regulatory environment, supply chain management), taking into account the impact of different forms of governance on the interoperability, cost, safety, regulatory control and access to safe, quality medical products;

    • 

  • include a cost analysis as well as a sustainability mechanism in their traceability system planning to prevent costs from negatively impacting patients, government, supply chain stakeholders and, in ultimately, access to medical products;  and use global standards for product identification, production identification, automatic identification, data capture and exchange to reduce system setup and operating costs and maximize the national and international interoperability.


    • 






		
		
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Generic drugs
		
Prescribing brand name drugs instead of generics costs Medicare $1.7 billion a year, study finds
		

	by
	
	Joan J. Dean	


	on
	



					
			

	

		

			
									

					

	



While distributing brand name prescription drugs accounts for only 5% of Medicare Part D claims, if brand name drugs were replaced by generic drugs, it could save save $1.7 billion a year. 


The study, published in the journal JAMA Open Network, looked at Medicare Part D prescription drug claims from 2017, which included 169 million prescriptions filled. 


The researchers also analyzed information from each request, including the type of drug dispensed, Medicare Part D expenses, and the patient’s out-of-pocket expenses. 


What the researchers found was that despite laws in all 50 states plus the District of Columbia that encourage the dispensing of generic drugs, 8.5 million of the 169 million prescriptions were branded when there were generic alternatives available. 


This means that approximately 30% of the time a brand name drug was used instead of a generic prescription drug. 


And to break this down further, 17% of the time was due to the prescribing partner requesting the brand name rather than the generic, while just over 13% was due to the patient requesting the drug from brand instead of the generic drug. 




But according to the study’s analysis, if all clinicians switched brand name prescription drugs with a generic option, it would have saved $977 million in one year and if patients had requested generic drugs instead of drugs branded, it would have saved an additional $674 million. 


“Even with laws in place, asking for a brand name drug happens far more often than it should,” said study co-author Gerard Anderson, a professor in the Department of Health Policy and Management. at the Bloomberg School.  “This distribution model results in exponentially higher costs for both the Medicare Part D program and for patients.”


In fact, according to the study, Medicare patients spent $270 million more than necessary on prescription drugs in 2017.


The study results shed light on the cost of brand name drugs for Medicare patients and the Medicare program, which, in case you forgot, is taxpayer funded. 


“Patients should always be aware of the additional costs to themselves and to taxpayers associated with requesting a brand name prescription drug,” said Ge Bai, associate professor at Johns Hopkins Carey Business School. 


But, despite the obvious financial benefits of only prescribing generic drugs instead of brand name drugs, it can be harder than it looks. 


One reason is that Medicare patients are often pressured to choose more expensive brand name prescription drugs over generic drugs.


According to a study published in 2019, some people enrolled in the Part D drug plan spend more on filling prescriptions for generic drugs than their peers spend on brand-name equivalents due to a manufacturer’s discount that reduces their personal expenses.  Indeed, the Affordable Care Act and the Bipartisan Budget Act do not apply to generic drugs. 


Thus, by reducing patients’ out-of-pocket expenses for biosimilars, but not for generic drugs – and by increasing discounts on branded products – physicians and patients are incentivized to switch to more expensive branded drugs.


Another reason is the various discount walls that prevent biosimilars and generic counterparts from succeeding in the market. 


But probably the biggest challenge when it comes to getting people to choose the generic over the brand name is changing people’s attitudes. 


Studies have shown that almost half of all clinicians have negative opinions about the quality of generic drugs.  Additionally, surveys have revealed that patients prefer brand name products to generics, and 46% of patients have asked their provider to prescribe a brand name drug over a generic.


And their skepticism is not unfounded. 


For example, generic drugs are not required by the Food and Drug Administration (FDA) to contain exactly the same amount of active ingredient or to deliver it at the same rate or in the same way.  In fact, they are allowed up to 10% variation in quantity when it comes to the active ingredient.


Generic drugs also don’t have to undergo the same rigorous testing as brand name drugs.  They do not have to go through clinical trials or prove therapeutic equivalence to be allowed on the market. 


There have also been well-documented issues with inconsistent manufacturing quality and inter-subject variability with generic drugs. 


For example, studies of antidepressants like Effexor and Celexa, as well as antipsychotics like Risperdal, Clozaril, and Dogmatil, have all found that some patients do significantly better on the brand name drugs. 


However, for the most part, generic or biosimilar drugs are well tolerated and are as effective as brand name drugs.


As such, Bai and Anderson suggest that creating policies that target both the clinician and the patient may have the greatest potential to promote the use of generic drugs and, therefore, reduce costs. 


They also suggest improving clinicians’ perception of generic drugs, raising awareness of generic drug availability, and limiting direct pharmaceutical marketing that can have a substantial influence on patient drug preferences.





		
		
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Generic drugs
		
Are generic drugs as safe and effective as brand name drugs?
		

	by
	
	Joan J. Dean	


	on
	



					
			

	

		

			
									

					

	



This article on generic drugs is based on information from the United States Food and Drug Administration.





Whether or not you have prescription drug coverage, if you use generic drugs when it suits your condition, you can save money — often 80-85% less than the prescription drug. brand.  But, are generic drugs safe?  According to the United States Food and Drug Administration (FDA), generic drugs are as safe and effective as their brand name counterparts.




YinYang/Getty Images




 


     What is a brand name drug?  




A brand name drug can only be produced and sold by the company that holds the patent for the drug.  Brand name drugs may be available by prescription or over the counter.  For example:



    

  • Tenapanor, a drug used to treat irritable bowel syndrome with constipation, is sold by prescription only by Ardelyx under the brand name Ibsrela.
    • 

  • Oxybutynin, a drug used to treat an overactive bladder, is sold without a prescription by Allergan under the brand name Oxytrol.
    • 



 


     What are generic drugs?  




When a brand name drug’s patent expires, a generic version of the drug can be produced and sold.  A generic version of a drug must use the same active ingredient(s) as the brand name drug and must meet the same quality and safety standards.  Additionally, the FDA requires that a generic drug be identical to a brand name drug in:



    

  • dosage
    • 

  • security
    • 

  • strength
    • 

  • the way it works
    • 

  • the way it’s taken
    • 

  • how it should be used
    • 

  • the health conditions it treats
    • 





All generic drugs must be reviewed and approved by the US Food and Drug Administration (FDA) before they can be prescribed or sold over the counter.



 


     Are generic drugs as safe and effective?  




According to the FDA, all drugs, including brand name drugs and generic drugs, must work well and be safe.  Generic drugs use the same active ingredients as their brand name counterparts and therefore have the same risks and benefits.





Many people worry about the quality of generic drugs.  To ensure quality, safety, and efficacy, the FDA subjects all generic drugs to a thorough review process that includes a review of scientific information about the ingredients and performance of the generic drug.  Additionally, the FDA requires that a generic drug manufacturing plant meet the same high standards as a brand name drug manufacturing plant.  To ensure compliance with this rule, the FDA conducts approximately 3,500 on-site inspections each year.





About half of all generic drugs are made by brand name companies. They can make copies of their own drugs or brand name drugs from another company and then sell them without the brand name.



 


     Why is it different?  




Generic drugs are not allowed to look exactly like any other drugs sold due to US trademark laws.  Although the generic drug should contain the same active ingredient as the brand name drug, the color, flavor, additional inactive ingredients, and form of the drug may be different.



 


     Does every brand name drug have a generic drug?  




Brand name drugs generally have patent protection for 20 years from the date the patent application was filed in the United States.  This protects the pharmaceutical company that paid for the research, development and marketing expenses of the new drug.  The patent does not allow any other company to manufacture and sell the drug.  However, when the patent expires, other pharmaceutical companies, once approved by the FDA, can start manufacturing and selling the generic version of the drug.





Due to the patenting process, drugs that have been on the market for less than 20 years do not have a generic equivalent sold.  However, your health care provider may prescribe a similar drug to treat your condition that has a generic equivalent available.



 


     Why are generic drugs cheaper?  




It takes more than 12 years to bring a new drug to market. It costs an average of $650 million. Since generic drug companies do not have to develop a drug from scratch, it costs much less to bring the drug to market.





Once a generic drug is approved, several companies can produce and sell the drug.  This competition drives prices down.  Additionally, many generic drugs are well-established, frequently used drugs that do not have to bear the costs of advertising.  Generic drugs can cost between 30% and 95% less than brand name drugs, depending on generic competition.



 


     Health care provider preferences  




Despite the fact that the active ingredient in a generic drug is the same as its brand name counterpart, small differences could affect how the generic drug works in your body.  This may be due to the way the generic drug is produced or the type and amount of inactive materials present in the drug.  For some people, these slight differences may make the medicine less effective or cause side effects.





An example of the generic versus brand name drug controversy is the drug levothyroxine, used to treat people with hypothyroidism (hypothyroidism).  Since many people with low thyroid are sensitive to very small changes in the dose of their medications, switching between branded and generic versions of levothyroxine can cause symptoms of too little thyroid medication or side effects from too much medicine.




Before switching to a generic drug, talk to your health care provider and make sure you’re both comfortable with the change.



 


     FDA Resources  





		
		
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Medical products
		
Lawmakers call for action for safer medical products
		

	by
	
	Joan J. Dean	


	on
	



					
			

	

		

			
									

					

	


	Six women in Congress are calling on federal regulators to take action to remove phthalates and other hormone-diverting chemicals from medical products, especially IV bags and neonatal equipment.





	The United States has made “minimal progress” in reducing harmful exposures in the United States over the past 20 years, even as alternatives become available and other jurisdictions, including Europe and California, take measures to reduce risk to patients, say Reps. Katie Porter, Jackie Speier, Anna Eshoo, Lucille Roybal-Allard (all D-Calif.), Susan Wild (D-Pa.) and Jan Schakowsky (D-Ill. ).





	“Patients should not be exposed to phthalates and endocrine disruptors [endocrine-disrupting chemicals] when seeking medical treatment,” the reps wrote in a letter to the acting head of the Food and Drug Administration, Dr. Janet Woodcock. “It’s also not something parents should worry about when their infant is receiving critical treatment in the neonatal intensive care unit.”



	Members of Congress have called on the FDA to create a “higher level” task force to do three things:



    

  1. Review and update FDA guidance on the use of phthalates and other hormone-diverting chemicals in IV bags and other medical equipment;

    2. 

  2. Identify and recommend the rules necessary to protect patients from exposure to toxic substances in medical products;  and

    3. 

  3. Establish an education program to make clinicians aware of the risks associated with the use of medical devices containing toxic additives such as DEHP.

    4. 



	“The time to act on this health risk is long overdue,” the lawmakers said.






                Evidence of harmful effect of DEHP on reproduction and fertility 



Manufacturers add phthalates like DEHP to plastic products to increase flexibility and reduce brittleness.  Some medical products such as IV bags and tubing may contain up to 40% DEHP by weight, according to a analysis by Safe Healthcare.


These additives leach to varying degrees from medical devices.  DEHP is particularly problematic, as extensive research suggests that exposures during critical periods of development can interfere with testosterone production and disrupt normal male reproductive development.


The European Union considers DEHP to be a reproductive toxin and an endocrine disruptor;  rules drawn up in 2017 require a risk-benefit analysis before phthalates like DEHP can be used in medical devices.


California has declared DEHP toxic to reproduction and development and a carcinogen and advises patients to request DEHP-free devices when seeking medical care.


Related: The danger of hormone-mimicking chemicals in medical devices and drugs


Meanwhile, the FDA hasn’t updated its rules since 2002, when it recommended that health care providers “consider” alternatives to DEHP when treating high-risk patients.


That must change, lawmakers say.


“Despite these findings and the growing body of evidence that confirmed previous research and identified additional risks of adverse health effects in vulnerable patients, there has been little progress in the United States over the past 20 years in reducing the use of DEHP in medical devices,” the lawmakers said.


“It’s time for the healthcare community to consider our role in exposing patients to potentially harmful chemicals.”




Download a copy of the letter here: 


Letter to FDA regarding DEHP IV bags.pdf


Banner photo by Martin LaBar/flickr





		
		
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Generic drugs
		
The size of the generic drug market is worth approximately US$675.2 billion per
		

	by
	
	Joan J. Dean	


	on
	



					
			

	

		

			
									

					

	


OTTAWA, Feb. 10  2021 (GLOBE NEWSWIRE) — The world generic drug market is expected to grow at a compound annual growth rate (CAGR) of 5.7% over the forecast period 2021 to 2030 and was valued at USD 387.92 billion in 2020.


    Why generic drugs?


Generic drugs refer to drugs that are chemically similar to an existing brand name drug.  These drugs are inexpensive and similar to brand name drugs in terms of potency, route of administration, consistency, effectiveness, and usage.  These are subject to administrative regulations in different countries, rather than associated with a particular company.  These drugs have proven to be as safe and effective as their brand name formulation, which has already been marketed.  While other characteristics, such as color, shape and aroma that do not influence the health and efficacy of pharmaceutical products that differ from the original edition;  generic versions are formulated with the same active ingredients as their advertised counterparts when working the same way and in quantity at the time.


Get the sample report pages for more understanding @ https://www.precedenceresearch.com/sample/1205


Growth factors:


The low price of generic drugs as a substitute for branded drugs is the supreme crucial factor in the growth of the global generic drugs market.  Generic drug manufacturers do not have to face high drug improvement costs and therefore the cost is 85% lower than brand name drugs.  Research and development costs, as well as drug discovery, are not included in the case of generic drugs.  A very small amount needs to be invested in pre-market data collection of generic drugs.  The companies rely on clinical evidence provided by the innovators’ company for the health and effectiveness of the drug.  Additionally, generic drug applicants do not need to repeat the animal and clinical (human) studies necessary to demonstrate the safety and effectiveness of branded drugs.  As a result, generic drugs, with similar active ingredients having the same strength, stability, purity, efficacy, and protection as brand name drugs, are available at a lower price than brand name drugs.  Such benefits lead patients to opt for generics as alternatives to expensive brand name drugs.  Another major factor that is expected to boost the growth of the target market in the near future is the increase in the number of branded drugs whose patent has expired.  Drug prices drop dramatically when patents expire.  The degree of price reduction varied greatly between products and nations.  The increasing prevalence of chronic diseases, diabetes and cardiovascular diseases creates a huge demand for these drugs.  However, the number of brand-name drugs whose patent has expired is constantly increasing in the North America region, which offers huge potential opportunities for the generic drug industry, as generic drugs offer various advantages over non-generic drugs.  For example, in 2019, the FDA approved approximately 108 generic patents in the United States alone.


Report Highlights:


    

  • On the basis of drug type, single generic drugs segment is expected to hold the largest revenue share during the forecast period 2021-2030.  This growth is mainly attributed to the low cost associated with generic drugs compared to super generic drugs.  Other supergenerics in the drug-type segment are expected to withstand a remarkable growth rate over the forecast period.
    • 

  • Based on therapeutic application, oncology therapeutic applications segment accounted for the largest revenue with a large share in 2020. This is attributed to the growing demand for the treatment of oncology disorders globally.  The cardiovascular segment is expected to grow at a reasonable CAGR during the forecast period.
    • 

  • Teva Pharmaceutical Industries Ltd.  leading player in the global industry esteemed for remarkable global market share.  The growth is accredited by the different business strategies adopted by the company.
    • 



Get personalization on this research report @ https://www.precedenceresearch.com/customization/1205


Regional analysis:


The report covers data for North America, Europe, Asia-Pacific, Latin America, Middle East and Africa.  In 2020, North America conquered the global market with a market share of over 30%.  The United States was the country with the most shares in the North America region, mainly due to the advanced healthcare infrastructure, the growing prevalence of chronic diseases and the presence of layers of head in North American countries.  The generic drug industry market in Asia Pacific is estimated to witness remarkable growth over the next 10 years.  The Chinese generic drug industry market is expected to dominate in terms of revenue in the Asia-Pacific region.  The increase in the prevalence of chronic diseases among the population as well as the increase in the initiatives of regulatory bodies to control them in the countries of the region is one of the main drivers for the growth of APAC.  Nevertheless, emerging markets in the AAC region are creating growth opportunities in the target market.


Browse more related [email protected] https://www.precedenceresearch.com/industry/healthcare


Key Market Players and Strategies:


The main companies operating in the world of generic drugs are Mylan NV Abbott Laboratories, ALLERGAN, Teva Pharmaceutical Industries Ltd.  Eli Lilly and Company, STADA Arzneimittel AG, GlaxoSmithKline Plc.  Baxter International Inc. Pfizer Inc. Sandoz International GmbH among others.  Investment in research and development of generic drugs along with strategic collaborations are the crucial business strategies undertaken by major players operating in the generic drugs market.


Market segmentation


    

  • Type of drug: Simple generics and super generics
    • 

  • By brand: Pure Generic Drugs and Branded Generic Drugs
    • 

  • By route of drug administration: Oral, topical, parental and others
    • 

  • By therapeutic application: Central nervous system (CNS), Cardiovascular, Dermatology, Oncology, Respiratory and Others
    • 

  • By distribution channel: Hospital Pharmacies, Retail Pharmacies, and Others
    • 

  • By regions: North America, Europe, Asia-Pacific, Latin America, Middle East and Africa (MEA)
    • 



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Generic drugs |  FDA
		

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In the United States, 9 out of 10 prescriptions filled are for generic drugs.  The increased availability of generic drugs helps create market competition, which helps make treatment more affordable and increases access to health care for more patients. Learn more about the FDA Action Plan on Drug Competition.


The FDA’s Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures that affordable, high-quality generic drugs are available to the American public by following a rigorous review process that includes:


New educational resources


    

  • Manage the regulatory process to facilitate drug approvals,
    • 

  • Establish scientific initiatives for generic drug research,
    • 

  • Publish data and reports on generic drug development and review, and
    • 

  • Provide educational materials and information.
    • 





Presentation and basic notions Presentation and basic notions


Information about the generic drug review process, FDA standards and pricing, and answers to frequently asked questions






Industry Resources Industry Resources


Electronic submission forms, requirements, tips, reports and other resources to help facilitate generic drug applications and approvals






Approval and reports Approvals and reports


First-time generic drug approvals, generic drug application review metrics, and generic drug program reports






Science and research Science and research


FDA Generic Drug Regulatory Science Initiatives, Research Priorities and Reports, Public Workshops, and Opportunities for Collaboration






Patient Education Patient Education


Infographics, brochures, handouts, posters, presentations, public service announcements and articles on generic drugs for educators, healthcare professionals and consumers




Learn more about the Bureau of Generic Drugs


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Generic drugs
		
While waiting for vaccine advances, we can trust generic drugs
		

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	Joan J. Dean	


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Generic drugs account for 90% of prescriptions filled in the United States.  They are the backbone of healthcare providers’ treatment protocol and they are remarkably cost-effective: although they account for 90% of prescriptions filled, generics only account for 20% of drug spending. 






Generic drugs account for 90% of prescriptions filled in the United States.  They are the backbone of healthcare providers’ treatment protocol and they are remarkably cost-effective: although they account for 90% of prescriptions filled, generics only account for 20% of drug spending.  But, while generics are indispensable to the US healthcare system and at the heart of the treatment of COVID-19, the future of the industry still remains uncertain.


As President Biden takes office amid a second wave of COVID-19 infections, it’s never been more crucial for policymakers to recognize the life-saving role generic drugs play.  Although generic drugs have long been proven to reduce health care costs, the critical role they have played during the global pandemic has reinforced the need for a healthy generic market and underscored the need for a policy that will support the sustainability of the generics and biosimilars industry.  .


Over the past year, the pharmaceutical supply chain has come under closer scrutiny than ever.  Generic drugs, from anti-inflammatory corticosteroids to sedatives used for intubation, have been the first line of treatment for COVID-19.  The increase in demand caused by the pandemic has caused pressure on the supply of medicines and closed transport channels.  Through innovation, perseverance and courage, the system worked and hospitals received the drugs they needed to treat patients with COVID-19.


Today, the supply chain discussion focuses on the last mile of vaccine delivery.  The public and private sectors have stepped up to distribute tens of millions of doses across the country, while getting shot in arms has been more difficult.  But as we wait for widespread vaccination, hospitals and patients will continue to rely on generic drugs, reinforcing the goal that generics serve to keep American patients alive.


Over the past two years, bipartisan action in Congress and cooperation between government and industry have contributed to policy initiatives such as passage of the CREATES Act and ratification of the USMCA.  We need to do more.  The generics industry is the only part of the healthcare sector that experiences price deflation year after year.  This deflationary trend combined with fierce competition and anti-competitive abuses by brand name drug manufacturers can drive manufacturers out of the market.  Fewer generic manufacturers will lead to higher drug prices or drug shortages, which would spell disaster for patients.






President Biden’s appointment of Xavier Becerra to head the Department of Health and Human Services will have far-reaching ramifications for America’s ability to fight the virus and ensure patient access to prescription drugs from high quality and low cost.  In the context of the COVID-19 pandemic, it will be essential for Attorney General Becerra to recognize the critical role that generic and biosimilar medicines play and help advance policy to support the sustainability of the generic pharmaceutical industry in the States. -United.


It is essential that the 117th Congress, together with Secretary-designate Becerra and other health care leaders in the Biden administration, make it a priority to address market failures and protect the long-term viability of the health care system. ‘industry.  Catch up with Europe in the use of biosimilar drugs instead of expensive biological therapies;  ensure that generic drugs are placed on the correct and least-cost generic formulary levels in Medicare Part D;  and fixing the Medicaid generic penalty that unnecessarily increases costs and cracking down on patent abuse by brand name drug makers are bipartisan priorities that will protect American patients now and in the future.  The AAM’s prescription for savings includes specific details about what Congress can do to expand access to low-cost generic and biosimilar medicines.


The health of the generics and biosimilars industry has never been more important to American patients.  In a letter to Congress, I outlined specific policy actions lawmakers can propose to make a real difference.  By working together, we can support the long-term sustainability of this essential industry and continue to expand access to high-quality, affordable and reliable generics and biosimilars.


Author Dan Leonard is CEO of the Association for Accessible Medicines.







		
		
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Encouraging competition through generic drugs
		

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	Joan J. Dean	


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The FDA is clarifying its generic drug approval process in an effort to encourage market competition.




Toxoplasmosis damages the brain, eyes and other organs, but the going price for treatment is $750 per pill.  However, the cost of this drug may soon drop as the United States Food and Drug Administration (FDA) has approved the first generic version of the drug, thanks to the new Drug Competition Action Plan (DCAP) of the United States. agency.


The FDA has credited DCAP for encouraging drugmakers to develop generic versions of brand name drugs.  The plan was designed to create market competition and reduce drug costs.  But the pharmaceutical industry needed additional guidance to navigate the generic drug approval process.


In an effort to clarify DCAP and generic approval pathways, the FDA released an industry guidance last month.  The guidance detailed incentives for drugmakers to develop generic versions of drugs without market competition.  The agency also updated its list of brand name drugs that are not protected by patent and do not face competition.  The FDA explained that these efforts were aimed at increasing the agency’s transparency and making the generic drug approval process more efficient.


These recent agency guidelines come three years after the FDA announced an earlier action plan and Congress amended the federal Food, Drug and Cosmetic Act to create a new generic approval pathway. .  Since this amendment in 2017, the FDA has continually provided updated resources with the goal of encouraging the approval of cheaper generic drugs.


The agency said its goal is to “remove barriers to generic drug development and market entry with the goal of stimulating competition so consumers can get the drugs they need at affordable prices.” affordable”.


Recently released guidelines have clarified the agency’s generic approval process.  According to the guidelines, a generic drug applicant can now apply to be designated as a Competitive Generic Therapy (CGT).  The FDA will label a drug as CGT when the only competitor in the market is the brand name drug and the brand name version does not have a pending patent.


Once a drug has been labeled as CGT, the product will receive 180 days of market exclusivity.  During this six-month period, the FDA cannot approve another form of the same drug.  This market exclusivity gives the drug manufacturer time to take advantage of the treatment without any competing generic products on the market.


The FDA also has the discretion to expedite the development and review of a product designated as CGT.  If the agency expedites the process, the FDA can participate in the drugmaker’s product development and pre-submission meetings.  These meetings give drugmakers the opportunity to discuss their concerns and explain the contents of their drug applications to the agency before submitting them for formal review.  The FDA has suggested accelerated development could help a manufacturer get its drug to market faster than it otherwise could through the traditional approval process.


In its guidelines, the FDA explained that market exclusivity and expedited review were created to encourage manufacturers to invest in generic therapies.  The agency recognizes that drugmakers may not be interested in developing generic forms of drugs that treat small patient populations or are complex and time-consuming to create.  Even though some generic drugs are not very profitable for the manufacturers, the public needs these generic products.  The FDA explained that more generics will ensure patients have better access to their drugs at affordable prices.


In an FDA report released in December, the agency found that drug prices continued to fall as more generics entered the market.  When there was a brand name and a generic version on the market, the manufacturer’s price of the generic version was on average 39% lower than the manufacturer’s price of the brand name drug.  The average generic manufacturer price continued to decline with more generic versions of the drug available on the market, according to the FDA report.


To help drugmakers determine what types of generic drugs to develop, the FDA also updated its list of brand name drugs that no longer have market exclusivity or patent protection and do not have competition. generic.  The list of drugs currently unprotected from generic competition is nearly ten pages long.  The FDA wanted this list to “enhance transparency” and encourage the development of generic forms of drugs that have no market competition.


Although the FDA has supported generic competition, researchers have questioned whether the quality of generic drugs is always equivalent to the quality of the branded version.  For example, a 2017 study looked at blood pressure medications and found that patients who took the generic drugs experienced more side effects than those who took the brand name version.  The authors of this study suggested that generic drug manufacturers need greater oversight to ensure adequate quality control.


Niteesh Choudhry, a physician and professor at Harvard Medical School, reviewed the study and suggested that differences in inactive ingredients may cause some patients to experience side effects after taking generics that they may not experience when taken. they take the brand name drug.


Although there may be slight differences in chemical compositions between generic drugs and brand name drugs, Choudhry always recommends that patients try generic drugs first, as the high cost of brand name drugs can cause patients to skip doses.  It recognizes that to control drug spending and keep drugs affordable to the general public, generic drugs must be available.


Even though researchers have questioned the level of efficacy of some generic therapies, the FDA has argued that increasing drug competition through generic development is a “top priority” for the agency and the US Department. Health and Human Services (HHS).


Alex Azar, the secretary of HHS, acknowledged that generic competitors drive down drug prices.  He praised the FDA’s efforts to review generic treatments, saying “the most obvious element of a more competitive pharmaceutical market is simply more options for patients, especially generic options.”





		
		
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California governor proposes that the state manufacture its own generic drugs
		

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The proposal, which is still largely conceptual, was part of Newsom’s proposed budget for 2020-2021.1






California Democratic Governor Gavin Newsom has introduced a sweeping proposal to reduce drug prices, suggesting that the state contract with one or more generic drug manufacturers to manufacture specific generic drugs on behalf of the state. ‘State.1 The proposal, which is still largely conceptual, was part of Newsom’s proposed 2020-2021 budget.1


Rising drug prices are an ongoing concern, with 79% of Americans saying the cost of prescription drugs is unreasonable, according to a Kaiser Family Foundation survey.2


In the survey, about 6 in 10 respondents reported taking at least 1 prescription medication, while 1 in 4 reported taking 4 or more prescription medications.2 As the number of prescriptions increases, respondents also reported that their ability to pay for them decreases.  Among those taking 1 to 3 prescription medications, 17% said it was difficult to purchase their medications.  However, of those taking 4 or more prescription drugs, 35% said it was hard to afford.2






Affordability also affects medication adherence, according to the survey.  Of those surveyed, 19% said they had not filled a prescription for a drug because of the cost, 18% said they had taken an over-the-counter drug instead, and 12% said they had reduced by half the pills or skipped doses.  These statistics correspond to 29% of patients who did not take their prescription drugs as instructed due to cost.2


Finally, the survey also found that a majority of Americans are dissatisfied with how politicians are handling rising drug costs, regardless of their political party affiliation.  According to the survey, 75% said Democrats in Congress were not doing enough and 77% said Republicans were not doing enough to solve the problem.2


This dissatisfaction may lead to more creative solutions, such as Governor Newsom’s proposal.  The program, called CalRx according to a press release,3 would allow the state to contract with one or more generic drug manufacturers to provide them to Californians for purchase.1 The plan would not apply to brand name prescription drugs.1


Proponents argue that the program would increase competition from generic drugs, thereby lowering prices.1 Opponents, however, said it was unlikely to change anything.


“If California enters the market on its own, it will face the same market dynamics that have led to generic prescription drug price deflation over the past 3 years, as well as some instances of abuse. of patents that have led to longer monopolies for certain brand-name drugs,” Jeff Francer, MPP, JD, general counsel for the Association for Accessible Medicines, said in a statement from the organization.4


The proposal, however, is not an entirely new idea.  Senator Elizabeth Warren (D-Mass) argued that the federal government should be allowed to manufacture its own generic drugs to reduce costs,5 and a group of more than 500 hospitals set up its own pharmaceutical company in 2018 to manufacture generic drugs at lower cost.6


“A trip to the doctor’s office, pharmacy or hospital shouldn’t cost a month’s pay,” Governor Newsom said in an interview with the Los Angeles Times.  “The cost of health care is just too high and California is fighting back.”seven


REFERENCES


    

  • 2020-2021 California Governor’s Budget Summary, Health and Human Services.  Released on January 10, 2020.  http://www.ebudget.ca.gov/2020-21/pdf/BudgetSummary/HealthandHumanServices.pdf.  Accessed January 13, 2020.
    • 

  • Public opinion on prescription drugs and their prices [survey].  Kaiser Family Foundation.  Posted November 20, 2019. https://www.kff.org/slideshow/public-opinion-on-prescription-drugs-and-their-prices/.  Accessed January 13, 2020.
    • 

  • Governor Newsom Proposes 2020-2021 State Budget [news release].  Sacramento, California;  January 10, 2020. Office of Governor Gavin Newsom. https://www.gov.ca.gov/2020/01/10/governor-newsom-proposes-2020-21-state-budget/.  Accessed January 13, 2020.
    • 

  • Subject: Pharmacy Times: Request for Statement on CA’s Proposed Generic Drug Program [email].  By Rachel Schwartz, Association for Accessible Medicines.  Received January 13, 2020.
    • 

  • Warren, E. Elizabeth Warren: It’s time to let the government make generic drugs [opinion]. The Washington PostDecember 17, 2018. https://www.washingtonpost.com/opinions/elizabeth-warren-its-time-to-let-the-government-manufacture-generic-drugs/2018/12/17/66bc0fb0-023f-11e9-b5df-5d3874f1ac36_story.  html.  Accessed January 13, 2020.
    • 

  • Civica presentation graphic. https://mk0sakunexoeoby9gsa0.kinstacdn.com/wp-content/uploads/2019/12/Civica-Overview-Graphic-1.pdf.  Accessed January 13, 2020.
    • 

  • Karlamangla S. Q&A: What you need to know about Governor Newsom’s pharmacare plan for California. Los Angeles TimesJanuary 9, 2020. https://www.latimes.com/california/story/2020-01-09/qa-newsom-prescription-drug-plan.  Accessed January 13, 2020.
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Op-ed: Why your generic drugs may not be safe and the FDA may be too lax
		

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Generic prescription drugs have saved the United States an estimated US$1.7 trillion over the past decade.  The Food and Drug Administration approved a record 781 new generics in 2018 alone, including generic versions of Cialis, Levitra and Lyrica.  They join the generic versions of the blockbusters of yesteryear, such as Lipitor, Nexium, Prozac and Xanax.


Seniors are the biggest purchasers of generic drugs because they take the most drugs and have a fixed income, but virtually everyone has taken a generic antibiotic or painkiller.


This leads to a vital question: are generics safe?  If drugmakers followed strict FDA regulations, the answer would be a resounding yes.  Unfortunately for those who turn to generics to save money, the FDA relies heavily on the honor system with foreign manufacturers, and American consumers are burned.  Eighty percent of active ingredients and 40% of finished generic drugs used in the United States are manufactured overseas.


As a pharmacist, I know that prescription drug safety is vital.  My research, recently published in the Annals of Pharmacotherapy, raises alarming concerns about our vulnerabilities.


Where are your medicines made?


Generic drug manufacturers make bulk powders containing the active ingredient or buy these active ingredients from other companies and process them into pills, ointments, or injections.


In 2010, 64% of foreign manufacturing plants, mostly in India and China, had never been inspected by the FDA.  In 2015, 33% remained uninspected.


Plus, companies in other countries are notified before an inspection, giving them time to clean up a mess.  National inspections are not announced.


False results


As I detail in my article, when foreign inspections announced by the FDA began to happen in earnest between 2010 and 2015, many manufacturing plants were subsequently prohibited from shipping drugs to the United States after the inspections revealed shady activities or serious quality defects.


Unscrupulous foreign producers shredded documents shortly before FDA visits, hid documents offsite, altered or manipulated safety or quality data, or used substandard manufacturing conditions.  Ranbaxy Corporation pleaded guilty in 2013 to shipping substandard drugs to the United States and intentionally making false statements.  The company had to remove 73 million pills from circulation and pay a $500 million fine.


These quality and safety issues can be deadly.  In 2008, 100 patients in the United States died after receiving generic heparin products from foreign manufacturers.  Heparin is a blood thinner used to prevent or treat blood clots in approximately 10 million hospitalized patients each year and is extracted from pig intestines.


Some of the heparin was fraudulently replaced with chondroitin, a dietary supplement for joint pain, to which sulfur groups were added to the molecule to make it look like heparin.


One of the heparin manufacturers inspected by the FDA received a warning letter after it was discovered that it used raw materials from uncertified farms, used storage equipment with unidentified materials adhering to it and had insufficient testing for impurities.


These problems persist to this day.  Dozens of hypertension and anti-ulcer drugs were recalled in 2018 and 2019 due to contamination with the potentially carcinogenic compounds N-nitrosodimethylamine or N-nitrosodiethylamine.


One of the main producers of these active ingredient powders used by several generic manufacturers was inspected in 2017. The FDA found that the company had fraudulently omitted failing test results and replaced them with passing grades.


This raises a crucial question: how many additional violations would occur if inspections occurred as frequently as in the United States, and more importantly, if they were unannounced?  Relatively speaking, the number of drugs found to be contaminated or substandard has been low, and the FDA has made progress since 2010. But the potential for harm is still great.


And after?


How safe should US residents feel when 80% of the active ingredients in our drugs are made overseas?  Evidence shows that the FDA cannot trust documents produced by foreign manufacturers to ensure that their products meet quality standards.  The widespread willingness of foreign manufacturers to falsify, manipulate, or shred documents in order to sell substandard or unsafe drugs to U.S. citizens shows that only frequent, unannounced FDA inspections or FDA testing of drug batches when they arrive in the United States will force them to follow the rules.


Patients taking prescription drugs are sick and vulnerable;  they should not be subjected to poor quality drugs that can make them worse.  Similarly, domestic generic drug makers that employ US citizens should not have to deal with stringent regulatory compliance that is effectively not required of foreign competitors.


It is costly, logistically difficult, and politically unpalatable for the FDA to show up for unannounced inspections of foreign factories.  If the agency does not have that right or the funding to expedite testing of their products here in the United States, they should not subject American citizens to drugs produced in foreign factories.  Unless we address this issue soon, I fear there will be a major incident where patients are killed and the goose that lays the golden eggs – those huge savings associated with generic drugs – will also be sacrificed .


Originally published in The Conversation. 





		
		
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US reliance on China for generic drugs is a security threat
		

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Last week, drugmaker Novartis issued a reminder generic versions of the popular heartburn medicine Zantac.  The Food and Drug Administration recently announced that the drug’s active ingredient, ranitidine, has been contaminated with a carcinogen known as NDMA.  On Monday, CVS has pulled Zantac and its generics from its shelves;  Walgreens had already stopped selling the drug earlier.






This recall will affect patients suffering from various conditions of excess stomach acid.  But it’s the security of the generic drug supply as a whole that should give every American heartburn.






Congress is currently focused on a legislative effort to reduce out-of-pocket spending on brand name prescription drugs.  It is a commendable effort.  Yet the other pressing problem with prescription drugs should not be overlooked: the safety risks posed by many generic drugs, which make up roughly 90% drugs that Americans take.






Ranitidine is just the latest in a string of generic prescription drug safety contaminations over the past few years.  Last year, the FDA announced that the same carcinogen had contaminated popular blood pressure medication valsartan, prompting a massive recall that affected Tens of millions of sick.






The biggest prescription drug crisis in recent years was the 2008 contamination of heparin, a widely used blood thinner.  The FDA estimates that 149 Americans died and several hundred others were seriously injured.






What is responsible for the repeated breaches of drug safety?  The relocation of US drug supply to China and, to a lesser extent, to India over the past two decades.






Lax safety standards and FDA oversight at factories in both countries have allowed these drugs — and likely countless others we don’t know about — to become contaminated and put patients at risk.  China and India now manufacture about 80% of drugs consumed in the United States This figure underestimates the dominance of China because many active ingredients of drugs manufactured in India come from China.  The United States no longer even manufactures life-saving drugs like antibiotics, with the last penicillin plant closing in 2004. 








In 2017, FDA inspectors investigation a factory of the Chinese company Huahai Pharmaceuticals, which manufactured contaminated valsartan, and found rust, deteriorated equipment, ignored consumer complaints, tested for anomalies and potential contamination.  Of them other Chinese herbs were cited by the FDA last year for inadequate cleaning and maintenance procedures, unlocked and improper registration forms, and inadequate testing, among other violations. 






FDA inspectors are unable or unwilling to provide proper oversight of Chinese manufacturing.  Unlike the rigorous testing required for the approval of new prescription drugs, the FDA does not requires that generic drug makers prove that patients will absorb the drugs at the same rate as the brand name drugs they copy. 






A 2016 Government Accountability Office report finds that some Chinese drug factories are never investigated, while others are rarely scrutinized.  At the time of the report, the FDA only has 29 employees to inspect more than 3,000 foreign manufacturing facilities.  And, the number of FDA investigators overseas fall 25% between 2016 and 2018, with two of the three control offices in China closing during the last years.  According to a Bloomberg analysis, the FDA checks the safety of less than 1% of foreign-made drugs before allowing them to enter the country.  And manufacturers are usually notified before inspections. 








Given the growing trade war and animosity between the two countries, the complete dependence on China for basic drugs from the United States also poses a threat to national security.  China’s dominance in drug manufacturing gives it a nuclear option in the ongoing trade war.  Millions of Americans could die without access to lifesaving drugs if China decides to militarize its drug manufacturing.






To ensure the safety of generic drugs and to protect against this threat to national security, the United States must produce its most life-saving drugs, such as antibiotics, insulin, and anesthesia, at home.  In their 2018 book “China RX,” Authors Rosemary Goodwin and Janardan Prasad Singh outline 10 steps to achieve this goal.  These include viewing drugs as a strategic asset, offering incentives to bring manufacturing home, and increasing FDA drug testing.






Lawmakers plan to hold hearings soon on China’s dominance in the manufacture of prescription drugs.  These hearings should recommend that any future comprehensive prescription drug legislation include an element of relocation.  If the status quo prevails, the country will continue to experience dangerous and widespread drug contamination – at best.







		
		
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The scary truth behind generic drugs in India
		

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	Joan J. Dean	


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Maybe because I’m a hypochondriac, I have great faith in medicine.  Every time I take a pill, I do so with confidence that it will work.  To my horror, I now find that this is terribly wrong in the case of many generic drugs and, in particular, those made in India.  Many are actually ineffective and a few even harmful.


That’s the key message of a book coming out next week called Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma.  According to its dust jacket, its author, Katherine Eban, “draws on more than 20,000 FDA (US Food and Drug Administration) documents and interviews with more than 240 people to show how fraud and betrayal are deeply rooted in much of the (generic drugs) industry in India and raises troubling questions about some of its biggest names – Wockhardt, Dr. Reddy’s, Glenmark and RPG Life Sciences”.


At the heart of this book is his research into Ranbaxy’s shameful history.  In 2013, in a well-publicized court case in America, the company pleaded guilty to seven counts of selling adulterated drugs and paid $500 million in fines.  This is what Eban concludes of Ranbaxy’s approach to testing drugs before they were sold: “You had to test the drugs to see if they were properly formulated, stable and effective.  The resulting data was the only thing that proved the drug would heal instead of kill.  Yet Ranbaxy treated the data as a fully fungible marketing tool…it was an outright fraud that could mean the difference between life and death…the company manipulated nearly every aspect of its manufacturing process to produce impressive data quickly that would strengthen his bottom line.”


Often, generic drug makers – not just Ranbaxy – produce higher quality drugs for European and US markets, where regulations are tighter, while blithely selling inferior and ineffective drugs in India.  Dinesh Thakur, the man who denounced Ranbaxy, told Eban, “Testing the drugs for India was just a waste of time…because no regulator ever looked at the data. .(the companies) just made up the records on their own and sent them to the Drugs Controller General of India (DCGI) What was needed for the DCGI was not real data but good connections.


Eban’s book is full of hair-raising accounts of visits by US FDA regulators to manufacturing plants in India, where fraud, unsanitary conditions and deliberately poor manufacturing standards are exposed.  In a factory microbiology lab, where they tested for germs and bacteria, there were no real samples: “They weren’t testing anything.  The whole lab was a fake.


If even a quarter of what Eban reveals is true, it’s scary.  This means that our faith in Indian generic drugs is often misplaced.  Often they don’t work.  Sometimes, no matter how many pills you take, they won’t treat the disease or infection.  If this is any comfort to you, this is also true for many Chinese generic medicines.


In September 2014, Dinesh Thakur, who is clearly one of Eban’s main sources, sought to meet Harsh Vardhan, then and now our Minister of Health, to alert him to the problem.  He was given five minutes, but Harsh Vardhan was more interested in the office TV screen showing news from Kashmir than in what Thakur had to say.  Finally, Harsh Vardhan asked “Thakur to send whatever he wanted to say in writing”.  But when Thakur did, “he never received a response.”


As a last resort, in 2016, Thakur appealed to the Supreme Court.  He proposed a PIL or public interest litigation.  His argument was that “India’s regulatory system was not only broken but unconstitutional”.  Raju Ramachandran was his lawyer.  But the judges refused a hearing.  In just 15 minutes.


What does that mean?  Neither the executive nor the judiciary are concerned about this deplorable situation.  You and I may continue to take generic drugs believing they work, but we are being ridiculed.  And the authorities simply don’t care.





Karan Thapar is the author of Devil’s Advocate: The Untold Story








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Karan Thapar is a super genius who is young, friendly, talkative and very funny.  It is also very pleasant to read.
    
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