Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs

#1

This report shocked me, I didn’t expect quality control of generics to be that bad. Some choice quotes:

ProPublica identified another alarming level of entrenched failure: Even when the agency did investigate and single out factories that were among the worst in India, it still gave them access to American consumers. All the while, patients took their medicine without question, trusting an agency that has long been considered the gold standard in drug regulation.

The FDA in many ways put itself in this untenable position, forced to decide between not having enough drugs or accepting potentially dangerous ones, interviews and government records show.

For years, the agency gave companies with a history of manufacturing breakdowns approval to produce an increasingly larger share of generic drugs, allowing them to become a dominant force in American medicine with the power to disrupt lives if production lines were shuttered

ProPublica’s analysis of that data found thousands of reports both before and after the factories were given a pass to sidestep import bans. The reports described unexpected cases of cardiac arrest, blurred vision, choking, vertigo and kidney injuries, among other issues — and in some instances identified specific concerns about how the drugs were made. One person who took Intas’ clonazepam, a sedative and epilepsy drug, reported getting “brain zaps” and bright blue teeth from the coating of dye on the drug. The FDA received the complaint the same month the agency exempted the drug from the import ban.

There’s much, much more. The issue seems to be that to avoid shortages, FDA is at the mercy of these generics manufacturers. The root cause seems to be some kind of market failure, since FDA apparently can’t actually punish manufacturers:

[…] a symptom of larger issues involving the drug supply that the FDA had no control over — the agency, for example, can’t force companies concerned about slim profit margins to produce generic drugs.

Those of us that buy directly from India better do more due diligence about where our products are coming from.

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#2

Yes, some of that was explored in the Bottle of Lies book, and I’ve been paranoid about it ever since. If at all possible, I try to buy original manufacturer drugs rather than generics (these too can be problematic!), and never ever go for some generic made by an unknown brand manufacturer. I feel like I’m gambling with every purchase, hard as I try😢.

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#3

Yes - this is an ongoing issue.

See related threads:

But we’ve had good results with rapamycin quality tests:

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#5

Generic cancer drugs used around the world fail quality tests, investigation shows

"Doctors from multiple countries told TBIJ that the drugs in question didn’t work as expected, leaving patients suddenly unresponsive to treatment. Other patients suffered side effects so toxic that they could no longer tolerate the medicine.

The variance found in the levels of active ingredients was alarming. In some cases, pills from the same blister pack contained different amounts.

These findings expose huge holes in the global safety nets intended to prevent manufacturers from cutting corners to boost profits, and to protect patients from bad drugs. All the while, patients and governments with stretched resources are paying the price for drugs that don’t work."

“Of 189 samples that had not expired at the time of testing, about one-fifth failed, meaning they had significantly more or less of the active ingredient than stated on the label. They consisted of 20 different generic drugs made by 17 manufacturers. (See the list here.) All but one of the companies is based in India.”

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Generally Good Indian Pharma Companies