Montana has become the first state to set up a licensing system that lets clinics offer experimental drugs, biologics, and devices to patients with a broad range of conditions, as long as those products have completed an early safety trial. The first treatment has already been authorized, and some biotech startups see the state as a possible shortcut around the FDA's lengthy approval process, Politico reported.
Under Senate Bill 535, signed by Gov. Greg Gianforte in May 2025, licensed experimental treatment centers may offer products that have completed Phase 1 testing but lack full FDA approval. The state's implementing rules were formally adopted this summer, Longevity. Technology reported. Unlike the federal right-to-try law, Montana's framework does not limit access to people with terminal illness.
