I’m very familiar with this space, specifically parenteral manufacturing.

The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.

As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.

And truly it gets worse every year…

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Amezarak 9 hours ago | parent [-]

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.

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infecto 6 hours ago | parent | next [-]

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.

	▲	lotsofpulp 6 hours ago \| parent [-]
		That is a problem of the government not inspecting imports and/or allowing them from places with known problems. If the government had said the imports from India are not allowed due to insufficient quality controls, then the market price for the generics would increase in the US, maintaining the necessary profit margins for the manufacturers to provide higher quality medicine produced at higher cost.

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s1artibartfast an hour ago | parent | prev | next [-]

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.”

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Amezarak an hour ago | parent [-]

Then they should have been transparent about it.

	▲	s1artibartfast 10 minutes ago \| parent [-]
		I probably agree with transparency, there is very little information on the ways in which the FDA was not transparent. the article states "And the agency kept the exemptions largely hidden from the public and from Congress." How so, are the examples? The FDA maintains a public red list of companies with import bans, and a green list companies operating under exemptions. What transparency are we talking about?

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delfinom 4 hours ago | parent | prev | next [-]

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.

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freejazz 4 hours ago | parent | prev | next [-]

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.

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indolering 8 hours ago | parent | prev [-]

But bacteria are all natural!