SB535 is a Montana law that expands pre-approval patient access to experimental drugs beyond federal Right-to-Try and Expanded Access by creating a regulated pathway for Phase 1 assets to be used outside clinical trials. Under the law, a physician can administer an investigational treatment if it completed FDA Phase 1 under an active IND, an independent state-registered review board (ETRB) approves the protocol, the drug is delivered at a state-licensed clinic, consent exceeds federal standards, and adverse events are reported. The critical change is that sponsors and clinics can charge for treatments, turning patient access from uncompensated risk into a priced commercial transaction intended to attract capital, reimburse providers, and generate real-world data.
The argument is that FDA-era incentives produced systemic overcaution and rising costs per approved drug (Eroom’s Law), leaving many promising assets stranded in a “Valley of Death” for lack of funded post-Phase 1 evidence. Montana’s design couples expanded liberties with accountability: ETRBs operate like IRBs with public COI policies, published decisions, review fees only, and mandatory outcome reporting. Common objections - patient harm, FDA enforcement, and quackery - are addressed through standard legal recourse, historical FDA enforcement patterns focused on rogue clinics, and transparency measures. The practical ask is for biotechs with Phase 1 assets to use the pathway and for ex-regulators to critique and improve the model.
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