4 ms·

FDA officials asked to step down after contentious Alzheimer’s drug approval

• dekhn 5y ago
  I work in pharma and literally every one of our leaders (we do Az research) says this approval made no sense, "even if you believe that plaques progression is an accurate proxy for mental deterioration". I expect it will actually be overturned, given what happened with Vioxx.
  • nceqs3 5y ago
    It likely will be revoked but the FDA gave them 9 YEARS for the phase 4! If they revoke the approval Biogen doesn't care, they will have made $100 billion, they are flying back to their HQ on their new gulfstreams and laughing at the morons at the FDA.
    • rasz 5y ago
      People inside FDA working diligently to make this happen dont sound like morons to me, they sound like second house in the Hamptons/Aspen types.
• radu_floricica 5y ago
  Consistency is important. I can't say most of the time that FDA is way too strict and is causing lives by delaying approvals, and then disagree when it approved a likely useless drug - even if the drug is likely useless. I'm going with the grey option and say that FDA should approve drugs primarily based on harm, with a note on usefulness. It then should be the decision of other regulatory bodies, or even better doctors whether the harm is worth the benefit for each individual case. And definitely there should be a separate decision on whether it's covered by Medicare - makes absolutely no sense to spend good money on a shady drug just because it got FDA stamp.