4 ms·
FDA described as a "clown show" amid latest scandal; top drug regulator is out
- duxup 1y ago>In early August, soon after joining the FDA, Tidmarsh announced actions that would effectively remove from the market a drug ingredient made by a company associated with Tang. Tidmarsh’s lawyer then sent a letter to Tang proposing that he extend a “service agreement” for “another 10 years,” which would see Tang making payments to a Tidmarsh-associated entity until 2044. The email was seen as attempted extortion, with such payments being in exchange for Tidmarsh rolling back the FDA’s regulatory change. Straight up extortion.
- Kapura 1y agoit's crazy how much of the current regime's position is "crime is legal if it's my guys doing it."
- watwut 1y agoTo be fair, that was always conservative position. Edit: I do not mean it cynically or as a joke. I think that is exactly what conservative position was for years. The only difference now is that it is not possible to euphemism away or plausible deniality away out of it.
- smithoc 1y agoIt's not, and the current administration isn't conservative. The MAGA movement has completely purged all the conservatives from the Republican party. They've increased the deficit by a trillion dollars, built an army of ICE agents and deployed them to terrorize people in cities around the country, added billions of dollars in import taxes, taken state ownership stakes in multiple companies. They're closer to Stalin or Mao than to any conservative ideology of a small government that stays out of people's business.
- tastyface 1y agoAnd yet the non-MAGA Republicans in Congress are (almost) fully complicit. After all, just a handful of their votes would be sufficient to shutter the whole operation.
- teddy-smith 1y agoThis makes me wonder how much of the Tariffs are extortion of other countries. How randomly they seem to be applied to makes me wonder if theres back room deals going on.
- yongjik 1y agoTrump tariffs are extortion. It's orthogonal to whether it's a good policy for the US, but nobody outside the US has any doubt about it being extortion. It's not even a back room deal kind of stuff; "Give America your money or I'll raise tariffs" is how Trump is openly talking to every country.
- tastyface 1y agoBackroom? The Korean government publicly gifted Trump a golden crown just last week!
- yongjik 1y agoWell as a Korean I can't say I'm proud of what happened, but if the choice is between "get robbed by someone who fancies himself a king" and "get robbed by someone who fancies himself a king, but also get a nuclear submarine deal" ...
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- timr 1y ago[flagged]
- 0cf8612b2e1e 1y agoSingular scandal? It is about the top dog using his position to settle a personal vendetta for financial gain.
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- timr 1y agoYes, that's one scandal, from one person. It has nothing to do with Vinay Prasad, certainly nothing to do with the CDC, and whatever you think of the administration, connecting this event to "everything else" is political hackery.
- bdangubic 1y agoput the one person for that one scandal into a federal prison - problem solved
- _yb2s 1y agoWhat about the nearly everyone else in the administration that is also a blatantly corrupt, unqualified, and incompetent bootlicker, many of which are even self described Nazis?
- bdangubic 1y agonot much different from any other asministration in the last 20-ish years. some are criming privately and some publicly but they are all criminals
- clown_show 1y ago[flagged]
- vibrio 1y ago“He had the temerity to reject a drug that had lousy data…” Was that data really “lousy”? (Referencing the REPL data?) Was it a trial design issue? (which he has very strong and unconventional opinions on) Is it the role of his position to overrule his specialist review teams ? (in the absence of any clear safety risks or malfeasance)
- terminalshort 1y ago[flagged]
- eulgro 1y agoMost people aren't equipped to be making such a decision.
- RobotToaster 1y agoDoctors are supposed to be.
- Retric 1y agoThey really aren’t, it’s the work of more than one human to keep up with this stuff. So you need a government agency or a private group doing the same functions while facing huge lawsuits and thus requiring the same or more data. Granted US doctors could use European etc guidelines, but that’s a different discussion.
- tartuffe78 1y agoYeah they loved giving people oxy
- terminalshort 1y agoIt's a risk reward tradeoff which is fundamentally not an objective decision. Nobody is equipped to make it.
- ubiquitysc 1y agoAt least clowns can be fun to watch
- _carbyau_ 1y agoFrom another country, it is mildly amusing in one sense of schadenfreude. It is also incredibly saddening to see great institutions of expertise be treated as playthings by the ignorant.
- viaoktavia 1y ago[dead]
- vibrio 1y agoIt’s much less fun if you have a loved one, say an aggressive autoimmune disease. Do not recommend.
- EverydayBalloon 1y ago[dead]
- pstuart 1y agoMy ex works in QA for a biotech company and FDA audits are a regular thing and are taken very seriously. There's plenty to criticize of the org (as with almost all others) but the rank and file are doing good work to help try to keep us safe.
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- wswope 1y agoI work in biotech and the FDA is openly reviewing our submissions with LLMs now. The shark has been jumped. https://www.fda.gov/news-events/press-announcements/fda-announces-completion-first-ai-assisted-scientific-review-pilot-and-aggressive-agency-wide-ai https://www.fda.gov/news-events/press-announcements/fda-anno...
- teddy-smith 1y agoI don't know. If this speeds up their work and helps them do more with the same staff I can see this as being a good thing. a.i. is really good at combing through data to answer questions.
- Balgair 1y agoIt will not. One (of many) issue is that this has no bearing on other regulatory regimes. So, sure, the FDA approves of the drug/device/thingy because the AI got lost and no one is checking what it's saying. But Canada's CFIA doesn't because they are still using real people or centaurs ( people + AI, but I'm not 100% sure so don't quote me on that ). That makes it so that you can only sell the drug/device/thingy in the US and some other countries that blindly follow US FDA (mostly poorer nations with very small markets and a lack of legal recourse, they'll just turn to the EFSA/EMA). Which fine, but that is not the bet that these large companies made about a decade ago when it came to whether or not this drug/device/thingy would be worth it to pursue. These big drugs need to pay off all the failed research with international sales. Same is somewhat true with devices (mostly internal these days). These big drug makers want stability. Profits are fine, but revenue is just as important as these pipelines are sooooo long and soooo fraught. The human body is just too variable. The tariffs and all the monkey business with this admin is very much not good for the US when it comes to these large drug/device/thingy makers. Chaos is not good for business. They have all learned that Donny and his ilk (per the article here) do not keep their words when it comes to corruption. They do not stay bought, they are not stable. We're already shedding jobs here in favor of moving to the EU. Yes, not India or China, but the Baltics mostly (inside Schengen zone). We lost 10 people with jobs opening up there (same day) just this last week. The EU is stable in the eyes of my very own bosses.
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- a-french-anon 1y ago[flagged]
- nougati 1y agoCan you clarify your meaning? Genuinely trying to understand. Is it that Beth criticises partisan actions (if you consider FDA's actions partisan, or the CDC's renaming of the mpox), while being partisan herself, which is hypocritical?
- watwut 1y agoShe has bluesky account. Checkmate. And also, if you are democrat or democratic leaning, you are not allowed to criticize republican administration. Criticism, insults and such can flow only one way - from conservatives to democrats. Checkmate.
- a-french-anon 1y agoTwo wrongs don't make a right. Sure, the US decision was certainly ideologically motivated (which isn't to say right or wrong) and one could notice that, but that rabid reaction to an absolute nothing is ridiculous and the arguments presented are questionable in tone and intellectual integrity (e.g. calling your side "the world" to put weight behind your opinion). Let's be honest, since Ars has been bought by Condé Nast, it has progressively become something between Reddit and Gawkers.
- like_any_other 1y agoSeveral times people here on HN dismissed factually accurate articles I posted, that cited all their claims to trusted, non-controversial sources [1], because they thought the article publisher was too right-wing. The only way such dismissals stop, is if they are applied evenly. [1] E.g. government statistics, or public announcements by a university regarding their programs, in an article about what kind of programs that university offers. I.e. sources nobody disputed for those claims.
- viaoktavia 1y ago[dead]
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