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The Collapse of the FDA
- dtagames 1y agohttps://archive.ph/0dddh https://archive.ph/0dddh
- mcphage 1y ago[flagged]
- umeshunni 1y agoThat's how most oppressive regimes end. Sometimes faster.
- sorcerer-mar 1y agoWhat's oppressive about FDA? Be specific.
- andrewflnr 1y agoThey obviously weren't referring "specifically" to the FDA at that point.
- sorcerer-mar 1y agoIt seems to me they were referring to FDA as a member among other "oppressive regimes" that fail in this way.
- andrewflnr 1y agoThe FDA didn't take 250 years to build up.
- nine_zeros 1y ago[flagged]
- monero-xmr 1y agoIt’s easy to hand out money when you are not the one paying, and have no consequences for success or failure. Feeling justified and righteous is the icing on the cake
- sorcerer-mar 1y ago[flagged]
- monero-xmr 1y agoGovernment agencies that spend massive amounts of tax dollars while accomplishing nothing and being net-negative for society. Anyone who has worked for or dealt with the government for extended periods of time will clearly know how fucked it is
- sorcerer-mar 1y agoAnyone 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 government, and especially FDA?
- monero-xmr 1y agoShould allow pharma to sell drugs to the market. Allow people to sue if they are harmed. Do not care about a government agency preventing access to new drugs. They can gatekeep government funds at best, limiting Medicaid / Medicare to those that want to pass their hoops My experience is in selling tech to government. Disgusting and corrupt.
- chung8123 1y agoUnfortunately I feel like we are just seeing the snap of these government agencies. They have been bending for a while. It will feel like 6 months but we have been on the path for a while and not one administration has decided to bite the bullet and turn course.
- reactordev 1y agoI was just saying this today. I’m originally from the DC bubble. It’s been bad for a LONG time. Entire companies designed to fight and win government contracts so that they can milk the government until retirement. SAIC comes to mind. These agencies haven’t been able to do their actual jobs in ages. Trump is doing what he said he was going to do (unpopular as that is) and we’ll have to figure out how to build back better (or whatever that term was). I don’t agree with anything he’s doing but I do see opportunities in it. If we can survive without these departments until then.
- js8 1y agoWhile seeing opportunity in a crisis is a good coping mechanism, that doesn't mean it's a good idea to destroy first and rebuild from scratch. (It is however one of the core unjustified beliefs of free market fundamentalists.) It actually seems to be true more generally, good coping mechanisms are not particularly efficient in the absence of crisis. Another example: People who lived through a dictatorship, which destroyed social trust and capital, learned to cope by distrusting state authorities. That's a coping mechanism that doesn't work well in the absence of dictate, a system that is open to democratic self-governance. You need people who are willing to apply more bold strategies to effectively run a democratic state.
- reactordev 1y agoLike I said, I don’t agree with his tactics. Burning the bridges isn’t smart. I do think a lot of DC fat is coping mechanisms. The bureaucracy is so slow to respond to change, change that this community loves, and needs a redo. Reorg. Whatever. I get why my opinion is so downvoted but the reality is the reality.
- stego-tech 1y agoDon’t give the buffoon too much credit, as a lot of these weaknesses were engineered starting around Reagan (with Carter and Nixon also shouldering some, but far less overall, blame). Neoliberalism and its “invisible hand of the free market” alliance with Laissez-Faire Capitalism all but ensured the demise of institutions and social safety nets in the name of maximum profit for the moneyed classes. We built a Golden Age atop the New Deal, and Capital threw it all away to return to the 20s, violent strikebreaking and all.
- King-Aaron 1y agoI see this argument of "oh it's been happening for a long time" getting thrown around a lot, and it feels like a really non-good-faith point of view that seems to ignore the administration directly targeting these institutions for destruction. Yes, poor management is a big problem that could be seen as an intentional structural issue, but this is a totally different ball game that's being played right now.
- deleted 1y ago[deleted]
- stego-tech 1y agoIt’s really not, though; it’s just the proverbial relief crew in a later inning of the same ball game. The players have been shuffled around or replaced, but look at the tenures of some of the players in question and you can draw a pretty direct line all the way back. It’s not minimizing or trivializing the harms of today by pointing out their origins in the past; rather, it’s acknowledging this has been a long-term goal of those in power for decades, and it’ll take decades of continued, organized change to improve things. There are no easy solutions or quick wins here. It’s a long game, always has been and always will be. More people need to understand that
- baggy_trough 1y ago[flagged]
- sorcerer-mar 1y agoCan you speak directly to what you're referencing, please?
- baggy_trough 1y ago[flagged]
- Cipater 1y agoThe FDA approved an average of 47 new drugs annually from 2015 to 2024. A few notables. Ekterly (sebetralstat) – Treats hereditary angioedema (approved July 3, 2025) Zegfrovy (sunvozertinib) – For NSCLC with EGFR exon-20 insertion mutations (July 2, 2025) Widaplik (amlodipine + indapamide + telmisartan) – Single-pill hypertension therapy (June 5, 2025) Tryptyr (acoltremon ophthalmic) – First in class dry-eye treatment (May 28, 2025) mNEXSPIKE – Next-gen Moderna mRNA COVID-19 vaccine (May 30, 2025) Emrelis (telisotuzumab vedotin) – Lung cancer (NSCLC) targeted therapy (May 14, 2025) Yutrepia (treprostinil inhalation) – For pulmonary arterial hypertension (May 23, 2025) Brekiya (dihydroergotamine autoinjector) – Acute migraine and cluster headache therapy (May 14, 2025) Gomekli, Journavx, Grafapex, Datroway – Novel agents in oncology and pain management (early 2025) Opzelura (ruxolitinib cream) – For vitiligo and atopic dermatitis (2022–2023) Cobenfy (KarXT) – New schizophrenia medication targeting cholinergic receptors (Sept 2024) Tarlatamab (Imdelltra) – First in class BiTE immunotherapy for small-cell lung cancer (May 2024) Pegcetacoplan (Empaveli/Syfovre) – First complement C3 inhibitor for PNH & geographic atrophy (May 2021) Leniolisib (Joenja) – First treatment for APDS immune deficiency (March 2023) Nedosiran (Rivfloza) – siRNA therapy for primary hyperoxaluria (Sept 2023) Retifanlimab (Zynyz) – PD-1 antibody for Merkel cell carcinoma (March 2023) Are you aware of any of these?
- sorcerer-mar 1y agoChallenge: Answer basic question with anything other than slogans Difficulty level: Impossible
- clumsysmurf 1y ago“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma." Anyone know what chelating compounds he is talking about? He mentions clean foods, but the Trump EPA is protecting corporations from regulations more than its protecting citizens from pollution.
- hinterlands 1y agoIt'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.
- Aloisius 1y agoIron, copper, zinc, cobalt, manganese and selenium are "heavy metals."
- grues-dinner 1y ago"Heavy metal" in general is a bad term, but especially when used as a proxy for toxin. There is no universal definition of heavy metal and there is no inherent connection to toxicity in any specific organism. Then again, pretty much every metal is toxic at some relatively low body-mass concentration, even iron (which actually can and does kill people, especially when children eat adult iron supplements). Even lovely unreactive gold does have compounds that are toxic.
- Tuna-Fish 1y agoEDTA removes all metals. It's simply a compound that forms water-soluble complexes with metal ions, removing them from the body. The way idiots kill their children with it is that among other metals, it removes calcium ions, and those are necessary for life, with low enough concentration in blood eventually resulting in cardiac arrest. So said idiots have an autistic child, read junk online that tells them that "toxins" caused this, find the compound that is legitimately used to remove toxins, and administer enough to end the autism. By stopping their child's heart. I don't particularly like the FDA, but restricting the availability of EDTA is not something I'd criticize.
- dmm 1y agoReading "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 1y agoThat seems more like an "underfunded and underjurisdictioned" problem for a portion of what they do, rather than collapse of the agency.
- Skates1616 1y agoI’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 1y agohttps://www.propublica.org/article/fda-drug-loophole-sun-pharma 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.
- kevin_thibedeau 1y agoI 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.
- alejohausner 1y agoI’ve heard RFK say that it’s hard to ban TV ads for drugs. They are “speech” according to the 1st amendment, or something like that. Too bad. News broadcasts are full of those ads, and hence TV journalists are loath to investigate the people that pay their salaries.
- vel0city 1y agoThere's loads of precedent pointing to commercial speech such as marketing as having some specific carve outs on the right to free speech. After all we have limits on tobacco marketing and food labeling requirements.
- HenryBemis 1y agoThe politicians are getting funded/paid (lobbying/donations) by the very same people/companies that pay the ad revenue to those media. Why on earth would politicians legislate against their actual bosses? (As a real life reminder - a dog that bites the hand that feed him is put down). Courts btw don't make up shit.. they 'judge' (verb) with the criteria of 'what does the law define'. So if politicians legislate wisely, courts will enforce any 'parliamentary' and/or executive order to ban the advertisements of medicine. But they won't. Not until push-comes-to-shove, and the true bosses will reposition to 'the next thing' (smoking, sugary-foods, medicine) and then they will allow the politicians to finally block meds ads. In which case the 'next wave' will begin. Story as old as time...
- alistairSH 1y agoThey used to be paid of RJ Reynolds, etc as well. The problem here is the drugs that are advertised as generally considered "good things". Anybody attempting to regulate the display of these ads would likely need to prove the ads are more harmful than any positive from the ads.
- pedro_caetano 1y agoWorth 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.
- King-Aaron 1y agoNeuralLink is suddenly going to get a miraculous green light for broad human trials hey
- Tade0 1y agoThat's a relatively minor danger. My father, before retirement, was responsible for certifying medical devices. The number of outright scams which reached his desk was off the charts. Half of that stuff didn't work as advertised, the other was actually dangerous, because it e.g. didn't control dosage.
- erchier 1y agoThe 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.
- Havoc 1y agoReject modernity. Return to the old ways Pity the old ways are > You’ve died of dysentery
- LadyCailin 1y agoIt 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.
- clauderoux 1y agoWell. There is measles epidemic right now...
- jdross 1y agoI’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
- tsimionescu 1y agoFeeling 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.
- ineedaj0b 1y agoi 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 unnecessary fluff, tremendous red tape (why do i need environmental review to stick a shed in my backyard??), our modern lives have too much regulation. let's hope for the best. the old system is holding back drugs.. there should have been more ozempics, more breakthroughs had the fda not been so slow. companies have a strong incentive not release bad drugs now.. lawyers are not cheap and law firms know money can be made.. it's not the 1930s anymore.. (okay it's still the 1930s in certain places of the world, that's a criticism) typing this out hoping to convince any regulation reduction is good reduction, i thought of a third fda option: the fda let's everyone go hog wild initially but looks at the top consumed products and checks them for safety and efficacy each year.
- awanderingmind 1y agoThis perspective is addressed in the article... TLDR; that doesn't seem to be where this is going.
- nosianu 1y agoIf 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 someone to point out that all we need is perfect regulation that exactly lets through all the good ones and filters all the bad ones....
- watwut 1y agoI will go further. In the snake oil market, trying to produce actually good novel drugs is a loosing strategy. You wont be selling more, because you will have exactly the same footing as those who just lie and exaggerate over their results. Except they will have more funds to spread those lies and to convince people, because they did not wasted money on research.
- UltraSane 1y agoThe FDA's creation was directly triggered by multiple mass poisoning incidents in the early 1900s.In 1937 over 100 people died from diethylene glycol-contaminated medicine, leading to the 1938 Food, Drug, and Cosmetic Act that significantly expanded FDA authority.
- 3D30497420 1y agoAs the adage goes, "regulations are written in blood". The problem is the blood was spent before many people can remember (or bother to remember). They just know the "limitations" imposed by those regulations and therefore want to get them removed.
- ourmandave 1y agoLike before his confirmation, when RFK wanted to Make Polio Great Again. And Mitch McConnell, who suffered from polio when he was 2 years old back in 1944, had strong words, but confirmed the anti-vaccine halfwit anyway. Good job Mitch!
- IAmBroom 1y agoMaybe it's like Jefferson's admonition that each generation must purchase their liberty in blood. Not happy about that possibility, but it is a possibility. "What's so bad about measles, anyway?"
- roenxi 1y agoThey also would like it if occasionally everyone reviewed legislation in light of whether it actually had a positive cost-benefit. The claim has to be something significantly more valuable than a few 100 people dying from poisons each year for the thousands to millions of deaths caused by inefficiencies in the biomedical industry. 3,000,000 people die in the US each year right now. Optimising the medical system for nimbleness and low costs is a much better path to take rather than optimising for something that is presented as a statistical rounding error. If people don't think a drug manufacturer is safe they don't have to buy drugs from them.
- 1y ago
- paul_milovanov 1y agoVinay Prasad, the new FDA chief medical and scientific director, is an extremely sensible guy and a co-author of a great 2013 book on evidence-based medicine targeting the lay audience (Ending Medical Reversal) Here's an EconTalk podcast with the other co-author, Adam Cifu, talking about the book. https://www.econtalk.org/adam-cifu-on-ending-medical-reversal/ https://www.econtalk.org/adam-cifu-on-ending-medical-reversa... The NYT article presents his COVID vaccine policy changes as yet more crazy MAGA shit, whereas in fact he holds nuanced views, based on up-to-date review of available evidence. He has published in NEJM and elsewhere on the topic: https://www.nejm.org/doi/full/10.1056/NEJMsb2506929 https://www.nejm.org/doi/full/10.1056/NEJMsb2506929 A short take on the above from Adam Cifu, whom I respect greatly: https://www.sensible-med.com/p/prasad-makary-and-an-evidence-based https://www.sensible-med.com/p/prasad-makary-and-an-evidence... With all of that, I suspect that the rumours of FDA's death are greatly exaggerated.
- LorenPechtel 1y agoHuh? That NEJM bit is crazy MAGA shit. It admits that if you're in a high risk group you should get it, but then turns around and says that because it hasn't been proven in every sub-group it shouldn't be done for the rest of the population. That makes no sense, it's just p-hacking in reverse. And it completely ignores the long covid elephant.
- Henchman21 1y agoDestruction precedes creation. Things have ossified to the point where change seems impossible. While I think the way we’ve gone about it is absurd, I can still hope that something better will replace it.
- insane_dreamer 1y agoThe one thing I liked about RFK is that he was going to "take on" the big food conglomerates and all the garbage that they are feeding Americans especially those unable to afford, or who do not have easy access to, healthy alternatives (whereas the garbage food is ubiquitous). It would seem dismantling the FDA is the opposite of that; what's needed are more regulations on food, or at least policies that result in more healthy food being available and affordable to Americans, not less regulation.