Montana's new biotech law lets drug sponsors charge patients for experimental treatments
Tell HN: An inside view of Montana's new biotech law
I helped shape Montana's SB535, a law that builds on right-to-try but lets sponsors and clinics charge for Phase 1-stage experimental treatments. It creates a state-registered review board to oversee safety and consent, aiming to fix the broken risk-reward ratio that traps drugs in the Valley of Death. Alex Tabarrok calls it the most important regulatory innovation in drug approval in his lifetime. My company formed the first such board.
When FDA approves a bad drug, heads roll. When it delays a good one, the deaths are statistical and nobody gets blamed ("invisible graveyard").
- estearum
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?
- zachthewf
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?
- colingauvin
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.