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The Collapse of the FDA

nytimes.com

91–100 of 220 posts

Re: The Collapse of the FDA

#91

I wish someone would convince RFK that prescription drug ads are bad for his brand of quack medicine. We could at least get rid of that societal cancer while the rest is torn down.

I don't think any convincing is needed.

https://x.com/RobertKennedyJr/status/1793144103800361050

> We are one of only two countries in the world that allow pharmaceutical companies to advertise directly to consumers on television. Not surprisingly, Americans consume more pharmaceutical products than anyone else on the planet.

> As I told @JoePolish, on my first day in office I will issue an executive order banning pharmaceutical advertising on television

Unfortunately, this is probably illegal. See cases like United States v Caronia.

Re: The Collapse of the FDA

#92
post #73

Reject modernity. Return to the old ways Pity the old ways are > You’ve died of dysentery

It really feels like the US is a failed state at this point, but it just hasn’t had full impact yet. Not really sure how all this destruction (in only half a year!) can be reversed in any meaningful timeframe in the future.

I’m not trying to challenge how you feel, but I’ll note that in my social groups people don’t feel this way, life is good, and they also feel confident that they’re well informed.

So I’m open to the possibility that lot of these types of feeling, in both directions depending on the political era, is more dictated by environment and media consumption choices and their versions of doom and gloom than reality

Re: The Collapse of the FDA

#93
post #73

Reject modernity. Return to the old ways Pity the old ways are > You’ve died of dysentery

It really feels like the US is a failed state at this point, but it just hasn’t had full impact yet. Not really sure how all this destruction (in only half a year!) can be reversed in any meaningful timeframe in the future.

As Sarah Chayes said about the "failed state" of Afghanistan:

> Afghanistan is often described as a “failed state,” but, in light of the outright thievery on display, Chayes began to reassess the problem. This wasn’t a situation in which the Afghan government was earnestly trying, but failing, to serve its people. The government was actually succeeding, albeit at “another objective altogether”—the enrichment of its own members.

From https://archive.is/CBQFY .

Was it here or in the reviewed book about corruption where it's mentioned, how corruption endangers security, because guess what the civilians who are mad about the blatant corruption will do when they see an insurgent plant a roadside bomb targeting the corrupt government?

As Supreme Court Justice Louis Brandeis said (and Timothy McVeigh quoted):

> In a government of laws, existence of the government will be imperiled if it fails to observe the law scrupulously. Our government is the potent, the omnipresent teacher. For good or for ill, it teaches the whole people by its example. Crime is contagious. If the government becomes a lawbreaker, it breeds contempt for law; it invites every man to become a law unto himself; it invites anarchy. To declare that in the administration of the criminal law the end justifies the means -- to declare that the government may commit crimes in order to secure the conviction of a private criminal -- would bring terrible retribution.

Re: The Collapse of the FDA

#94
post #9

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 pol…

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

Re: The Collapse of the FDA

#95

Earlier quoted context omitted.

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

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 manu…

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.

Re: The Collapse of the FDA

#96
post #82

i know this is a very political thing now but i've had friends (smart phd people who work industry) very annoyed at the fda for many years, and maybe this collapse is good! the fda started with a noble mission but they've been getting heavy handed. or better cliched - slow handed with getting things certified. you can solve this one or two ways: drop regulation or increase staffing. so many institutions have unnecess…

If you would give a balanced PoV you would not only count the good drugs that could have been, but also list all the bad ones that were fortunately prevented from being released on the public. If you only list one side, your argument is missing something essential. Loosening regulations has an effect not only on drugs that turn out to be very net positive, we will also see more bad ones. Now I'm just waiting for some…

some drug are moneymakers. lots of people can take them. viagra was that or now ozempic etc. but there's lots of novel drugs that never get past testing because they cost too much or the market too small to recover profit.

these studies struggle to find candidates, the testers rarely have serious side effects, so i think on the net this will not cause the harm you worry.

however! i would be worried taking new broad market drugs post any fda collapse.. but there's fewer of those on average. and pharma companies compete on efficacy and side effects and love to show investors results. so mixed bag.

we play it too safe. ozempic will save many many lives. if it had been approved years earlier it would have saved many many more. waiting for perfect is what the current system feels like, and seems like something you also know is foolish.

18 studies. only 6 novel. not a healthy ecosystem imo

Re: The Collapse of the FDA

#97
post #92

Earlier quoted context omitted.

It really feels like the US is a failed state at this point, but it just hasn’t had full impact yet. Not really sure how all this destruction (in only half a year!) can be reversed in any meaningful timeframe in the future.

I’m not trying to challenge how you feel, but I’ll note that in my social groups people don’t feel this way, life is good, and they also feel confident that they’re well informed. So I’m open to the possibility that lot of these types of feeling, in both directions depending on the political era, is more dictated by environment and media consumption choices and their versions of doom and gloom than reality

Feeling well informed is not the same thing as being informed. Just because it's possible to live in the USA and follow some news without knowing how badly the democratic order is being eroded doesn't mean that all is actually well.

Do your friends know about the absolute immunity the Supreme Court invented for the president? Do they know about the illegal deportations that are accelerating? Do they know about the presidential order that aims to deport legal citizens of the USA (the end of birthright citizenship)? Do they know about the gutting of virtually all social programs?

If they don't, then they're ill informed, regardless of their feelings on the matter. If they do and still think all is well, then they are just as much a part of the problem as the ones doing this all.

Re: The Collapse of the FDA

#98

Earlier quoted context omitted.

It's about EDTA. It can be legitimately used to treat heavy metal poisoning, plus some other things. Some people (who are probably misguided) want to self-medicate. The FDA won't let you. Hence, drama.

Iron, copper, zinc, cobalt, manganese and selenium are "heavy metals."

Wow, that's an interesting rabbit hole: https://en.wikipedia.org/wiki/Heavy_metals.

> Even in applications other than toxicity, no widely agreed criterion-based definition of a heavy metal exists. Reviews have recommended that it not be used. Different meanings may be attached to the term, depending on the context.

Re: The Collapse of the FDA

#99

Worth reminding everyone that, on top of pharma and food, the FDA also regulates medical devices. Insufficient regulation both on approval _and_ inspection of medical devices (thinking surgical applications and implantables for example) is as impactful on patient safety as drugs.

The damage to U.S. government safety institutions by the current administration may be significant, from faulty pacemakers and cancer-inducing scanning machines to disabled babies and Ebola.

It’s not some temporary thing where we can just raise awareness and then people will vote them out of office next time. The changes that have been made affect the ability for those opposing to win the next election, and even if they were to, the checks and balances have gone.

At this point, unless you plan to work to undo it long-term, you could accept that our society will be quickly devolving maybe 100-150 years or more.

In the past, opportunity abounded in fake science, magical thinking, weird products, dirty industry, manual labor, inequity, and brutish behavior.

If they want to outlaw processed foods and we all start eating flavorless thick hard biscuits of grain and beans and less-than-stellar-looking fruits and vegetables, it’ll probably be better for my mental and physical health.

However, that may be offset by my teeth rotting from lack of fluoride and getting cancer and intestinal problems from lack of regulation. And the death, disease, and disablement will overshadow the fear and excitement from street fights, arcing electrical devices, dangerous bubbling chemicals, planes falling from the sky, things exploding, medicine shows, and AI whorehouses.

Re: The Collapse of the FDA

#100

Earlier quoted context omitted.

Anyone who has worked in drug development knows how vital FDA is. The FDA costs taxpayers less than $4 billion per year. If FDA is a net negative, next time you need a medication you're aware you can go participate in a Phase I study, and get paid to take a cutting edge drug for it? Why bother looking at the stuff on the medicine shelf that costs you money? Can you give us all an idea of your experience working with…

The actual budget of the FDA is $4 billion. The overly restrictive regulations it puts on drug development and manufacture of generic medication costs 10-100x that.

"If you think safety is expensive, try an accident!"
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