October 2021

Khuba calls on doctors and health workers to promote the use of generic drugs

by Joan J. Dean on October 29, 2021

Calling on doctors, health workers and ASHAs to promote the use of generic drugs, Union Minister of State for Chemicals and Fertilizers Bhagwanth Khuba said on Friday that the drugs significantly reduce the cost drugs for people.

Speaking at Janaushadhi Mitra Sammelan, Mr. Khuba said that 145 generic drugs are available at Janaushadi Kendras and these drugs are sold at a cost less than 70% to 90% of the cost of brand name drugs. “By making generic drugs available at an affordable price, Prime Minister Narendra Modi has helped people save on drugs to a great extent,” he said.

Citing an example, Mr Khuba said that the brand name drug Atorvastatin, which is prescribed to lower cholesterol, costs 12 per pill, while the same drug is available at 0.98 paise at a generic pharmacy.

The Union Minister of State urged the government and private doctors to prescribe more generic drugs. He said that Anganwadi workers and ANMs should educate doctors and the population about generic drugs. He also called on the operators of Janaushadhi kendra to carry out activities to raise awareness about the availability of medicines for hypertension, diabetes and chronic diseases, which are regularly consumed by many people.

During the interaction with Mr. Khuba, some of the representatives of the 82 Jananushadhi Kendra in Dakshina Kannada pointed out the poor quality of some of the drugs provided. Another Kendra operator raised the issue of getting Suvidha sanitary napkins for the price of 1, for which there is good demand. A doctor, who has a Janaushadhi Kendra near his hospital in Puttur, expressed the need for more essential drugs in the kendras.

Khuba said the ministry was taking action to address issues related to the quality and supply of medicines. “It’s an ongoing process and we are responding to your concerns. We sincerely believe in making quality essential medicines available to the population, ”he said. Changes are being made to the Janushadhi Sugam app to give people a clear idea of the drugs available in the kendras, he said.

MP Nalin Kumar Kateel and MP for Mangaluru City South D. Vedavyas Kamath spoke.

Mr. Khubha and Mr. Kateel presented the Janaushadhi Prabhuddi Prize to the Udupi District Administration, the district being the first among Karnataka districts in terms of sales of generic drugs. The two men also presented Janaushadhi Mitra Awards to seven people, including three doctors, for the promotion of Janaushadhi Kendras.

Generic drugs

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

by Joan J. Dean on October 27, 2021

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.

Medical products

Medical Product Supply Chain Week in Review – October 2021 #2 | Alston and bird

by Joan J. Dean on October 25, 2021

Last week, the FDA cleared booster doses for Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses. The FDA has also proposed a new rule for over-the-counter (OTC) hearing aids. The Ports of Los Angeles and Long Beach moved to 24/7 operations to help ease supply chain congestion. Please see details of these and other supply chain developments below:

On October 13, President Biden noticed on the Administration’s efforts to eliminate bottlenecks in the global transportation supply chain. Through the infrastructure bill and the Build Back Better Act, the president hopes to invest $1 billion to advance supply chain operations. In the meantime, the ports of Los Angeles and Long Beach will be operational 24 hours a day, seven days a week to move cargo from the ports to their destination terminal. Home Depot, Walmart, Target and Samsung have pledged to work harder to move products from ports to stores, especially during off-peak hours. UPS and FedEx have also pledged to allocate more resources to overnight delivery.
On October 14, the Center for Devices and Radiological Health Posted draft guidelines, “Select updates for unique device identification: policy regarding global unique device identification database requirements for certain devices.” This draft guidance provides updates to FDA policy on global identification (label) requirements for Class I devices. The public comment period ends December 13, 2021.
On October 14, the FDA announcement that the Antimicrobial Drug Advisory Committee meet on November 30 to discuss the EUA submitted by Merck and Ridgeback Biotherapeutics for molnupiravir. The drug, which is administered orally, would be the first COVID-19 antiviral authorized for self-treatment in a home care setting. The intended use is for individuals with mild to moderate COVID-19 disease who are at high risk of progression to severe disease.
The FDA announcement a public meeting, “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA),” scheduled for November 16, 2021. The purpose of the meeting is to provide stakeholders with an opportunity to engage with the FDA of the status of their progress towards meeting the system and data requirements of an interoperable tracking system for prescription drugs. The registration deadline is October 26, 2021. The FDA will accept individual comments on the meeting until January 18, 2022.
On October 19, the FDA offers a new rule to establish a new category of OTC hearing aids. The rule would apply to certain air conduction hearing aids intended for adults 18 and older who have perceived mild to moderate hearing loss.
On October 20, the FDA amended EUAs for Moderna and J&J’s COVID-19 vaccines to allow for booster doses. The indication for the Moderna booster is for administration six months after the completion of the initial series of vaccination doses for persons 65 years of age and older, persons 18 to 64 years of age with risk factors for severe disease, and those whose occupations put them at risk. of exposure. For the J&J booster, the indication is for administration two months after a first vaccination for all individuals 18 years of age and older. The FDA also allowed the mixed administration of doses from different manufacturers.

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Generic drugs

The pros and cons of generic drugs explored

by Joan J. Dean on October 24, 2021

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.

Generic drugs

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

by Joan J. Dean on October 20, 2021

20 October 2021

2 minutes to read

Source / Disclosures

Published by:

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

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.

Medical products

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

by Joan J. Dean on October 15, 2021

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.]

Medical products

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

by Joan J. Dean on October 14, 2021

For immediate release:: October 14, 2021

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.

Generic drugs

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

by Joan J. Dean on October 8, 2021

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.

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SOURCE Technavio

Prescription drugs

DEA investigation into Ryan Vermillion linked to prescription drug cashout

by Joan J. Dean on October 7, 2021

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 NFLPA sent every certified agent a notification that it had opened an investigation into the DEA searches of Washington football team facilities in Ashburn and the nearby home of head athletic trainer Ryan. Vermillion. pic.twitter.com/n824RlnOr5

— Nicki Jhabvala (@NickiJhabvala) October 7, 2021

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.

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 October 5, 2021

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.

Medical products

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

by Joan J. Dean on October 4, 2021

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.