Well that'll be a pretty sophisticated scheme, requiring $5-10m funding per phase-1 trial. I suppose that's possible but it would be a highly legible scheme.

Also what would be the bad outcomes here? If those drugs end up not being safe (that is prevented by the requirement to not withhold safety data), or being effective?

If effectiveness is what you're thinking of, keep in mind things like off-label are already allowed, so even in the current system you have drugs that aren't proven effective for what they're used and we don't call the physicians that prescribe off-label bad actors necessarily.

INDs and phase 1s are expensive and not trivial in any sense.

- Strong demand from biotechs (first approval decision made and public, Parley Neurotech), we're talking several dozens with $5-300m in funding each

- Clinics a bit more lagging, because licensing takes up to 90 days; in a few weeks we hopefully see the first clinic

- Business models: I'd personally be very excited about open-sourcing phase-1 assets to encourage further development to better drugs by more people

- Yes, this was an explicit hope from the geroscience community to address gaps e.g. in frailty, age-induces diseases with multiple possible endpoints

- No explicit rules on telehealth, but administration needs to be in Montana under a brick-and-mortar clinic; telehealth probably possible within those limits

Maybe, but if it's GRAS and supplements/non-drug interventions, can't you do it anyway? This law is addressed at products that are regulated as drugs, biologics and medical devices

I 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.)

Super substantive comment that should definitely not be `dead`. Vouched. Curious for OP's answer.