> Why this exists: When FDA approves a bad drug, heads roll. When it delays a good one, the deaths are statistical and nobody gets blamed ("invisible graveyard"). So the incentive is overcaution, which is why the cost per approved drug has roughly doubled every 9 years for decades ("Eroom's Law").
You need to put this into more layman terms because I don't know what any of this means.
Are you trying to fast-track something and the Montana state legislature approved it? What is this?
In what way does the Montana law make snake oil salesmanship hard? Why can't a bad actor just repeatedly file INDs, go through Phase 1 (soon will be close to trivial given AI-enabled drug discovery/design), then sell to unsuspecting consumers as a panacea, then rinse and repeat?
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.
> Why this exists: When FDA approves a bad drug, heads roll. When it delays a good one, the deaths are statistical and nobody gets blamed ("invisible graveyard"). So the incentive is overcaution, which is why the cost per approved drug has roughly doubled every 9 years for decades ("Eroom's Law").
You need to put this into more layman terms because I don't know what any of this means.
Are you trying to fast-track something and the Montana state legislature approved it? What is this?
In what way does the Montana law make snake oil salesmanship hard? Why can't a bad actor just repeatedly file INDs, go through Phase 1 (soon will be close to trivial given AI-enabled drug discovery/design), then sell to unsuspecting consumers as a panacea, then rinse and repeat?
[delayed]
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.