If you have first-hand knowledge of the FDA’s torpor, get in touch

Re:If you have first-hand knowledge of the FDA’s torpor, get... by mlinhares on Thursday August 03, 2023 @10:48PM (#36994904)

It’s an incredibly hard place to be, if they approve a drug that eventually is proceed to cause more harm than good, they’ll hang, if they don’t approve, there’s little consequence.

It’s the same problem of being lenient to criminals, if they do nothing and become good citizens that do not commit crime anymore, you gain nothing as a politician, if they commit a crime your career is over.

Given society itself doesn’t value the risks as they should be, why are we expecting the agents of society itself to behave in a manner that will harm them?

[ Parent | on HN ]

Re:If you have first-hand knowledge of the FDA’s torpor, get... by phkahler on Thursday August 03, 2023 @10:54PM (#36994951)

>> It’s an incredibly hard place to be, if they approve a drug that eventually is proceed to cause more harm than good, they’ll hang,

Not really. Fentanyl should be a schedule 1 drug but instead we have people getting addicted and dying at crisis levels. And don't forget Vioxx which killed half a million people over 5 years.

So yes, it's a hard place to be but they will not hang when they get it wrong.

[ Parent | on HN ]

Re:If you have first-hand knowledge of the FDA’s torpor, get... by CaliforniaKarl on Thursday August 03, 2023 @10:57PM (#36994975)

> Fentanyl should be a schedule 1 drug but instead we have people getting addicted and dying at crisis levels.

Fentanyl is already a Schedule 2 drug, and as someone who has had Fentanyl administered during (medical) operations, I think that's where it should remain.

[ Parent | on HN ]

Re:If you have first-hand knowledge of the FDA’s torpor, get... by sdfignaionio on Thursday August 03, 2023 @11:29PM (#36995159)

Fentanyl should definitely be Schedule 2, like it is right now. It has a wide variety of accepted medical uses and can be used safely with medical supervision.

[ Parent | on HN ]

Re:If you have first-hand knowledge of the FDA’s torpor, get... by fnord77 on Thursday August 03, 2023 @11:07PM (#36995037)

I don't think making Fentanyl Schedule 1 will stop the deluge of illegal Fentanyl coming into the US, nor will it make a dent in abuse

[ Parent | on HN ]

Re:If you have first-hand knowledge of the FDA’s torpor, get... by renewiltord on Friday August 04, 2023 @01:54AM (#36995952)

If you haven't received it, you know nothing. It's a wonder drug and is exactly where it should be legally. Bloody thing made so much tolerable.

The puritan trend runs deep, though, eh? People must suffer. They must not have pain relief.

[ Parent | on HN ]

Re:If you have first-hand knowledge of the FDA’s torpor, get... by crote on Friday August 04, 2023 @03:19AM (#36996543)

Look at the response to thalidomide in Europe. It caused a massive scandal and directly resulted into significant law changes in a significant number of countries.

[ Parent | on HN ]

Re:If you have first-hand knowledge of the FDA’s torpor, get... by slavboj on Thursday August 03, 2023 @10:52PM (#36994940)

People keep saying this I have seen no evidence that anyone at the FDA "hangs" when they approve a drug with unexpected negative outcomes.

[ Parent | on HN ]

Re:If you have first-hand knowledge of the FDA’s torpor, get... by xp84 on Thursday August 03, 2023 @11:48PM (#36995272)

While you’re right technically that we don’t see direct repercussions on particular regulators, I think the sentiment itself is close enough to true, because what would probably happen if they ever did rush something to market that caused a bunch of problems is that everyone would suddenly scream for essentially, and return to the extreme conservatism that we are used to seeing from them today.

To put it another way, public outcry, which seems to only stem from bad approvals and not bad denials/delays, will probably always push hard on any version of the FDA causing them to reach an equilibrium point which ends up surprisingly far on the conservative side of the scale. This sucks and I don’t know what to do about it besides the stupid solution I wish for of just having a smart, benevolent, powerful, and incorruptible monarch in charge of everything.

[ Parent | on HN ]

Re:If you have first-hand knowledge of the FDA’s torpor, get... by pirate787 on Friday August 04, 2023 @08:03AM (#36998776)

The FDA's cultural topor and designed bias against approval is almost entirely from the Thalidomide disaster.

https://pubmed.ncbi.nlm.nih.gov/21507989/

https://www.gvsu.edu/cms4/asset/F51281F0-00AF-E25A-5BF632E8D...

[ Parent | on HN ]