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progree

(13,023 posts)
7. Threat in your medicine cabinet: The FDA's gamble on America's drugs
Wed Jun 18, 2025, 09:09 AM
Jun 2025
Threat in your medicine cabinet: The FDA’s gamble on America’s drugs , ProPublica via Minnesota Public Radio website, 6/17/25

https://www.mprnews.org/story/2025/06/17/threat-in-your-medicine-cabinet-the-fdas-gamble-on-americas-drugs

In the part I read (about half of it), there were horribly egregious contamination, sanitation, and quality problems at an India pharma manufacturing company, but the FDA allowed some of its products to continue to be made and sold in the U.S. I'm sorry this is a lousy summary, but I never asked to be born. But here we are

The part I read is pre-Trump II. Uggh that the situation is going to get a lot worse.

ETA first paragraphs:

On a sweltering morning in western India in 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant surrounded by barricades and barbed wire and demanded to be let inside.

For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers at the tablet presses, mixers and filling machines that produce dozens of generic drugs for Americans.

Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were “blackish” from contamination had been sent to the United States. Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown “extraneous matter” were used anyway, mixed into batches of drugs.

Sun Pharma’s transgressions were so egregious that the Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States.

But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America’s drug supply.

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