FDA described as a "clown show" amid latest scandal; top drug regulator is out

>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.

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Kapura 2 days ago | parent | next [-]

it's crazy how much of the current regime's position is "crime is legal if it's my guys doing it."

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watwut 2 days ago | parent [-]

To 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.

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smithoc a day ago | parent [-]

It'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 a day ago \| parent [-]
		And 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.

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teddy-smith a day ago | parent | prev [-]

This 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.

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yongjik a day ago | parent | next [-]

Trump 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.

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tastyface a day ago | parent | prev [-]

Backroom? The Korean government publicly gifted Trump a golden crown just last week!

	▲	yongjik a day ago \| parent [-]
		Well 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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vibrio 2 days ago | parent | prev | next [-]

“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)

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ubiquitysc 2 days ago | parent | prev | next [-]

At least clowns can be fun to watch

	▲	_carbyau_ 2 days ago \| parent \| next [-]
		From 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.
	▲	vibrio a day ago \| parent \| prev [-]
		It’s much less fun if you have a loved one, say an aggressive autoimmune disease. Do not recommend.

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pstuart 2 days ago | parent | prev [-]

My 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 2 days ago | parent | next [-]

I 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-anno...

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teddy-smith a day ago | parent [-]

I 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.

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Balgair a day ago | parent | next [-]

It 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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KuhlMensch 13 hours ago | parent [-]

> not India or China, but the Baltics mostly

Interesting.

So you're seeing "scientific development" pipelines (research/development/trials) moving wholesale to EU?

	▲	Balgair 8 hours ago \| parent [-]
		In parts for now, not wholesale yet. And more than just RnD, it's other sectors of the corpo too.

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cameldrv a day ago | parent | prev [-]

Waiting to see the job posts popping up for a prompt engineer for FDA submissions.

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cosmicgadget a day ago | parent | prev | next [-]

And they are slowly being attrited by layoffs, being led by corrupt shitbirds, and the Russell Vought ethos of making career public servants miserable.

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vibrio a day ago | parent | prev [-]

This. They don’t get paid much, or much glory if any, but overall they are smart and hard working and are eager to have rational and data driven discussions about the programs they oversee. Current status is heartbreaking.