Montana has become the first state to license clinics that can sell access to experimental treatments still working through the FDA’s approval pipeline — a striking expansion of the “right-to-try” movement, reports Vicki Norton for The Washington Post.
From a right to an infrastructure
Montana already broadened right-to-try beyond terminally ill patients in 2023. Its 2025 law, S.B. 535, goes further: it creates licensed health care facilities authorized to recommend and administer drugs, stem cell procedures and antiaging therapies that have cleared Phase 1 safety trials but remain years from FDA approval. The state’s health department adopted rules in July requiring side-effect reporting, independent review boards and licensed medical directors, addressing early fears that the law prioritized access over safety.
Still unresolved is whether the federal Food, Drug, and Cosmetic Act’s ban on shipping unapproved drugs across state lines exempts this broader model, and whether the FDA will look the other way. Manufacturers eyeing Montana’s market, the piece argues, need that clarity now — not after Congress or the agency eventually weighs in.
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