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?
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.
> 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?
Barring a time machine, safety data reporting is gonna lag at least some of the bad outcomes.
Thanks for posting - have been following from afar and very interested in this area. Sorry for the naive questions, I am a software guy new to biotech.
- How have things looked since passage? Has there been a lot of interest from companies and patients or is demand the bottleneck? Not that many people in Montana...
- What sort of new business models does this open up? e.g. Roivant for abandoned phase 1 assets?
- Does this lower the barrier for treating new indications, e.g. age related conditions like sarcopenia?
- 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
Very much regret not having been able to attend last night, but kids came down with the return to school virus. Big fan of this law and also putting MT more on the map for biotech.
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
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.
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.
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?
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.
> 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?
Barring a time machine, safety data reporting is gonna lag at least some of the bad outcomes.
That is the same with all post-market monitoring for drugs. And maybe we can do better because more nimble/startup approach in a small state
Isn't this pre-market, though?
Relative to the federal approval it's pre-market. In Montana, if your treatment is approved by a review board it's in market
INDs and phase 1s are expensive and not trivial in any sense.
Thanks for posting - have been following from afar and very interested in this area. Sorry for the naive questions, I am a software guy new to biotech.
- How have things looked since passage? Has there been a lot of interest from companies and patients or is demand the bottleneck? Not that many people in Montana...
- What sort of new business models does this open up? e.g. Roivant for abandoned phase 1 assets?
- Does this lower the barrier for treating new indications, e.g. age related conditions like sarcopenia?
- Any particular rules on telehealth?
- 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
Very much regret not having been able to attend last night, but kids came down with the return to school virus. Big fan of this law and also putting MT more on the map for biotech.
Very interesting. I work in Parkinson’s space so I am familiar with the problem!
Does this also work for GRAS so things like supplements or other non-drug interventions can be tried in the new model?
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
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.
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.