>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.
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.
“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)
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.
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.
>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.
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.
it's crazy how much of the current regime's position is "crime is legal if it's my guys doing it."
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.
“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)
At least clowns can be fun to watch
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.
It’s much less fun if you have a loved one, say an aggressive autoimmune disease. Do not recommend.
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.
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...
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.
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.