https://www.propublica.org/article/fda-drug-loophole-sun-pha...

> Digging through company records and test results, they found more evidence of quality problems, including how managers hadn’t properly investigated a series of complaints about foreign material, specks, spots and stains in tablets.

> Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a “cascade of failure” at one of the Intas plants, finding workers had destroyed testing records, in one case pouring acid on some that had been stuffed in a trash bag. At the second Intas factory, inspectors said in their report that records were “routinely manipulated” to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company’s 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.

> A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. [...] And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details.

FDA inspectors found actual, live contamination in drugs produced by a manufacturer, and the agency secretly (otherwise, it would have caused "some kind of frenzy" in the public") gave it an exemption anyway, to make sure supply wasn't impacted. This isn't a "funding" issue, and it's not a "regulations are too strict" issue. This is an issue with the people running the agency behaving completely inappropriately.

I think it can be both actually. The FDA through over regulation scared local manufacturing from generics which are generally low margin. Overtime you become dependent on Indian generics which have a horrible track record, this is a country that has massive lead contamination from spices and the government does nothing about it. Too late now the ship has sailed and you are now forced to utilize these. No doubt it’s a structural problem in the FDA but it can also be one where perhaps the stakes were kept too high for manufacturing in the US.

This all seems entirely reasonable. This is a cost benefit calculation. If bad drugs kill 1 person, and drug shortage kills 100, what do you choose?

The FDA chose a practical middle ground. Ban what isn't critical, and for those that are, they put additional mitigations in place:

> Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing.

>“The odds of these drugs actually not being safe or effective is tiny because of the safeguards,” said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. “Even though the facility sucks, it’s getting tested more often and it’s having independent eyes on it.”

Older article from 2019:

https://www.npr.org/sections/health-shots/2019/05/12/7222165...

>Internal divisions and pressure from Congress also limited the FDA's response to overseas violations,

whistles

>delays in launching a generic version of Lipitor could cost Americans up to $18 million a day, according to a 2011 letter from a group of U.S. senators to the FDA commissioner.

It can be true that not every function of the FDA works as intended, while it still does provide functions that are crucial to American society and are being removed.

But bacteria are all natural!