HELENA, Mont. (Diya TV) — Montana has begun implementing a law that allows patients to seek certain experimental medical treatments through state-licensed treatment centers after early-stage clinical testing.
Lawmakers approved Senate Bill 535 in 2025. The law expanded Montana’s existing Right to Try Act and created a licensing system for experimental treatment centers. State regulations governing those centers took effect July 25.
Under the law, eligible treatments generally must have successfully completed a Phase 1 clinical trial and must not have received Food and Drug Administration approval for general use. Montana law also allows certain treatments with documented clinical safety evidence from a qualified medical institution.
Phase 1 studies primarily evaluate a treatment’s safety, side effects and how it behaves in the body. Later clinical trial phases generally provide more information about effectiveness.
Patients seeking treatment under Montana’s program must consider available FDA-approved options, obtain a recommendation from a treating health care provider and provide informed consent. The law allows providers and treatment centers to charge patients for experimental therapies.
The program differs from the federal Right to Try Act, which generally applies to patients with life-threatening diseases or conditions who have exhausted approved treatments and cannot participate in a clinical trial. Montana’s eligibility requirements do not include a life-threatening illness requirement.
Montana requires licensed experimental treatment centers to establish or contract with an Experimental Treatment Review Board. Each board must include at least five members, including a Montana-licensed physician, a clinical outcomes researcher and an ethicist. The boards review treatment protocols, safety information, informed-consent procedures and risk-benefit assessments.
The state also requires treatment centers to report serious adverse events to the Montana Department of Public Health and Human Services within five days.
A privately operated review board established through Infinita has approved a treatment developed by Denver-based Parley Neurotech for hearing impairment. The treatment combines sound therapy with clemastine fumarate, an antihistamine already approved by the FDA for other uses. Parley is also studying the treatment in an FDA-authorized clinical trial.
Patients have not yet received the treatment through Montana’s program because the state had not issued a license to an experimental treatment center as of the latest reporting. Two center applications were pending, according to the state health department.
Montana’s Department of Public Health and Human Services is responsible for licensing experimental treatment centers and enforcing the state’s operating, reporting and safety requirements.
