5 ms·
>but huge penalties if they approve a drug or device that goes bad. What penalty does the FDA face?
by fnordfnordfnord 11y ago
>but huge penalties if they approve a drug or device that goes bad.
What penalty does the FDA face?
- AnimalMuppet 11y agoCongress (who controls their budget).
- Fomite 11y agoCongress gives them plenty of slack for being slow to approve things.
- AnimalMuppet 11y agoYes. And very little if they approve something too fast that causes problems.
- Fomite 11y agoExcept that there are counter-examples to this. The FDA's careful for a reason. For example, take the first Rotavirus vaccine (Rotashield), which was associated with intussusception (it's no longer clear it even caused it). It was pulled from the market, but Congress definitely got involved, an newer, unrelated rotavirus vaccines have very, very active post-market intussusception surveillance studies associated with them.
- fnordfnordfnord 11y ago"Congress" isn't a penalty. Budget reductions are a constant threat, and I'd consider that threat more a function of the politics of the majority leader than of whether or not the FDA had to issue a recall or got some bad press.
- jessriedel 11y agoRestrictions on budgets, transfer of some authorities to other agencies, firing of the leadership, embarrassment and loss of status (and so reduced future job prospects) of the leadership. One recent example: http://nationalpainreport.com/activists-want-fda-commissioner-fired-for-opioid-approvals-8824940.html http://nationalpainreport.com/activists-want-fda-commissione...
- fnordfnordfnord 11y agoThis is FUD and politics. It sounds like a defense of analysis paralysis as a survival tactic; as if the only goal is to never get fired, even if it means that nothing ever gets accomplished.