Third member of U.S. FDA advisory panel resigns over Alzheimer’s drug approval

Re:Third member of U.S. FDA advisory panel resigns over Alzh... by dcolkitt on Friday June 11, 2021 @09:58AM (#27473401)

I agree. And regardless of where you stand on the issue, the current regulations with regards to off-label usage are totally inconsistent. Doctors are perfectly free to prescribe drugs for conditions that are completely unrelated to the what they were approved for.

Drug X is proven safe but not proven effective. It's illegal to use to treat condition Q under any circumstances. Drug Y is proven safe, proven effective for condition M. It's perfectly legal to use for unrelated condition Q. How does this make any sense?

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Re:Third member of U.S. FDA advisory panel resigns over Alzh... by spiorf on Friday June 11, 2021 @10:09AM (#27473550)

Because it cuts economic incentive to produce ineffective (but safe) drugs on purpose.

[ Parent | on HN ]

Re:Third member of U.S. FDA advisory panel resigns over Alzh... by SpicyLemonZest on Friday June 11, 2021 @10:22AM (#27473745)

Maybe, but it’s not clear to me that the FDA is (or should be) experts in weighing economic incentives for good behavior. There’s plenty of bad economic incentives created by the current FDA process; just ask the Lovaza guys, charging a 10x markup for fish oil. In an ideal world, I don’t think the FDA should have any role in drug approvals other than preventing direct medical harm.

[ Parent | on HN ]