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December 2019

Generic drugs

Op-ed: Why your generic drugs may not be safe and the FDA may be too lax

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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