Montana's SB535 Lets Biotech Firms Charge for Pre-Approval Treatments Under State Oversight

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Montana has enacted SB535, a law that expands access to experimental drugs beyond existing federal Right-to-Try frameworks by allowing sponsors and clinics to charge patients for pre-approval treatments that have completed FDA Phase 1 trials. The law requires approval from a state-registered private review board called an ETRB, delivery at a licensed clinic, and mandatory adverse-event reporting with enhanced informed consent standards. Proponents argue the legislation addresses a structural flaw in drug development where sponsors under federal rules cannot recoup costs, trapping promising therapies in a funding gap known as the Valley of Death after Phase 1. Economist Alex Tabarrok has described SB535 as the most significant regulatory innovation in drug approval in his lifetime, citing how overcaution at the FDA creates an 'invisible graveyard' of delayed treatments. Critics and supporters alike are watching to see whether the FDA will challenge the state law, and at least one company has already formed the first ETRB to begin operating under the new framework.

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