Tell HN: An inside view of Montana's new biotech law
Montana's SB535 lets sponsors of Phase 1 IND drugs treat patients for payment under state-registered ETRB oversight, reshaping trial economics.
Montana's SB535 extends right-to-try by allowing physicians to administer experimental treatments outside trials if the drug completed FDA Phase 1 under an active IND and a state-registered review board (ETRB) approved the protocol. It is described as the first state law letting sponsors charge for IND-stage treatments, aiming to counter Eroom's Law cost growth and the Phase 1 'Valley of Death.' The author, who contributed to the law and formed the first ETRB, says oversight includes enhanced consent, adverse-event reporting, and published decisions. The item is biotech regulation, off-topic for a cyber/AI dashboard.
- Requires Phase 1 completion, ETRB approval, licensed clinic delivery, enhanced consent
- First state law allowing sponsors to price IND-stage treatments
- 68% of failed trials stop for commercial rather than safety or efficacy reasons
- Alex Tabarrok called it the most important drug-approval regulatory innovation in his lifetime
- Products
- SB535
- Organizations
- FDAMontana state government
- Countries
- United States
From the original article
3 min read at news.ycombinator.comMontana passed a law called SB535. It builds on right-to-try (pre-approval access with informed consent, Phase 1 safety data etc.) but goes much further, fixing problems with those laws.
By niklas_anzinger · news.ycombinator.com
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