4 ms·
Wouldn't you be asking the physicians to risk their licenses to administer these drugs? The state can't waive the Food, Drug, and Cosmetics act, so a physician
by hlieberman 15d ago
Wouldn't you be asking the physicians to risk their licenses to administer these drugs? The state can't waive the Food, Drug, and Cosmetics act, so a physician doing so is breaking federal law unless they get a single-patient IND or EUE. I guess if the experimental drug is manufactured in the state, maybe you could claim the FDCA doesn't apply, but... that's a big risk.
- estearum 15d agoSuper substantive comment that should definitely not be `dead`. Vouched. Curious for OP's answer.
- niklas_anzinger 15d agoI think what you're describing is a risk to the sponsor/biotech, not the physician. It is not a clear-cut question though for the sponsor, because US states regulate medical practice. Federal jurisdiction applies when there is interstate commerce, and that risk exposure depends largely e.g. on how you do manufacturing and past FDA enforcement history. Also there are options where some of the activities you need to do you can do through federal right-to-try. So it depends on what you're trying to do but is not "you can't use it" by default. (Not legal advise.)
- estearum 15d agoYou don't think a physician is at risk of a malpractice suit for prescribing a drug that has only passed Phase 1 and ends up hurting someone...?
- niklas_anzinger 14d agoPhysicians get a pretty good liability shield in the law; is that strong enough against malpractice suits? I don't know, but it hasn't been raised much as a problem relative to the sponsor risk