Reading "Bottle of Lies" by Katherine Eban, I'd argue that the collapse of the FDA was well underway before the current administration. The FDA was completely unable to regulate overseas drug manufacturers, resulting in many, many problems. Sincere attempts to inspect overseas drug makers with random inspections universally results in shutdowns, which cause politically unpopular drug shortages, making enforcement politically difficult.

▲ cosmicgadget 17 hours ago | parent | next [-]

That seems more like an "underfunded and underjurisdictioned" problem for a portion of what they do, rather than collapse of the agency.

▲ Skates1616 16 hours ago | parent | next [-]

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…

▲

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.

▲

infecto 7 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 7 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.

▲

s1artibartfast 2 hours 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.”

▲

Amezarak an hour ago | parent [-]

Then they should have been transparent about it.

	▲	s1artibartfast 41 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?

▲

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.

▲

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.

▲

indolering 8 hours ago | parent | prev [-]

But bacteria are all natural!

▲ teepo 14 hours ago | parent | prev [-]

It feels to me like the tyranny of small differences. The fact that the various watchdogs amplified such specific issues greatly overshadowed their support of the mission. From what I've read, the FDA is a backwater from a funding perspective, and yet a punching bag from a regulatory point-of-view.

  *He and his colleagues had also been engaged in a decades-long debate with a sprawling community of watchdogs — mostly doctors, lawyers and scientists from outside the agency — who were often broadly supportive of the agency’s mission but who fought with officials like Califf, sometimes bitterly, over the specifics: How should the F.D.A. be financed? What kind of evidence should new drugs and medical devices require? How should regulators weigh the concerns of industry against the needs of doctors, patients and consumers?*

▲ ethan_smith 12 hours ago | parent | prev | next [-]

The 2018 valsartan recall is a perfect example of this - an overseas manufacturer's nitrosamine contamination went undetected for years despite theoretical oversight, affecting millions of patients.

▲ sorcerer-mar 17 hours ago | parent | prev | next [-]

Sooo that sounds like there's a whole lot of ways for it to get way, way, way worse.

The existence of problems does not imply there cannot be more plentiful, more diverse, and more severe problems in the near future.

▲

kelseyfrog 15 hours ago | parent [-]

If Chesterton's fence doesn't have a working latch, then it's appropriate to remove it entirely.

▲

sorcerer-mar 7 hours ago | parent | next [-]

We know for a fact (like actual empirical fact) that FDA prevents vast numbers of unsafe and ineffective drugs from reaching the market. This is absolutely indisputable.

So uhhh, maybe we think in reality instead of offloading to metaphor.

▲

throwaway173738 6 hours ago | parent | next [-]

The whole “let’s paint a general principle with a broad brush over this highly nuanced thing I know nothing about” is a huge problem with discourse in our society.

▲

throwawaymaths 4 hours ago | parent | prev [-]

> We know for a fact (like actual empirical fact) that FDA prevents vast numbers of unsafe and ineffective drugs from reaching the market. This is absolutely indisputable.

we also know for a fact that the FDA lets unsafe and ineffective drugs into the market, especially from overseas, slapped with a label that its safe according to the FDA. if its a crapshoot, what's the point really?

	▲	sorcerer-mar 3 hours ago \| parent [-]
		The point is that it's nowhere close to a crapshoot. 99.99999% of drugs ever created are unsafe or ineffective. 99%+ of the drugs you will ever encounter in your life are both safe and effective. That is not a crapshoot. Obviously.

▲

wizzwizz4 8 hours ago | parent | prev | next [-]

If Chesterton's fence is intangible and invisible, then it's appropriate to remove it entirely. If it doesn't have a working latch, it doesn't serve as a hard barrier, but it may still serve as a soft barrier, and that may be good enough.

Or, conversely, important things may have been relying on access via the latch-free fence gate: fixing the latch without providing a more appropriate solution to those issues could cause more harm than the benefit you get from "now the fence actually functions as a barrier". (Sure, the latch keeps the wolves out, and stops them picking off the sheep – but it also keeps the sheep away from their only freshwater source, without which most of the sheep are going to die.)

▲

satvikpendem 15 hours ago | parent | prev [-]

Or fix the latch? Or was this a sarcastic comment?

▲

rabeener 15 hours ago | parent [-]

https://fs.blog/chestertons-fence/

	▲	satvikpendem 15 hours ago \| parent [-]
		I know what Chesterton's fence is, my question was specifically about why one would throw it away if the latch doesn't work.

▲ PetriCasserole 9 hours ago | parent | prev | next [-]

That just means the FDA was restricted. The FDA is fine. The people funding the FDA are not.

▲ zer00eyz 15 hours ago | parent | prev [-]

Chiron: 2004, the UK government shut down their flu vax plant (it was in the UK). It later came out that the FDA knew what was up and basically let it slide. It was one of the early ani-vax movements torches... Crunchy moms pissed about shots for kids and parents on Oxycodone were not happy with Pharma (or corporations in general: Enron etc..)

> politically unpopular drug shortages ...

Ask your ADHD friends about how they get their meds.

One side wants to keep it, the other side wants to get rid of it. No one wants to fix the problem.

	▲	aspenmayer 13 hours ago \| parent [-]
		> No one wants to fix the problem. That’s not what wedge issues are for. They’re not meant to be solved, because then they’re used up, and there’s airtime to fill in the meantime.