GoKawiilMontana's SB535 lets clinics charge for post-Phase 1 experimental treatments
Montana has enacted SB535, a law that extends right-to-try provisions by allowing physicians to administer treatments that have cleared FDA Phase 1 trials outside formal clinical trials, provided a state-registered review board approves the protocol and care is delivered at a licensed clinic. Unlike federal right-to-try or expanded access rules, the Montana law permits sponsors and clinics to charge patients for these treatments, addressing what backers call the core funding gap facing biotech firms after early trials.
GoKawiil's interpretation of the reporting above, not reported fact.
Drug developers often stall in the 'Valley of Death' after Phase 1, when grant funding dries up and investors wait for further trial results before committing capital; allowing revenue from paying patients could keep promising therapies alive long enough to reach approval. Because federal regulatory reform is politically difficult, a state-level experiment like Montana's could become a model—or a cautionary tale—for how to rebalance drug-safety caution against the hidden costs of delayed treatments.
- SB535 lets state-approved clinics charge patients for post-Phase 1 experimental treatments.
- The law aims to fix the 'Valley of Death' funding gap that kills many promising drugs before approval.
- It's framed as a state-level alternative to stalled federal right-to-try and expanded-access reforms.
Source: news.ycombinator.com, 2026-09-16
Published there as: “Tell HN: An inside view of Montana's new biotech law”
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