Montana has created a route for patients with any condition to obtain experimental treatments that have cleared only Phase 1 safety trials, under a law that permits companies and clinics to charge for care. The state is relying on a privately operated Experimental Treatment Review Board, or ETRB, to approve treatment protocols without Food and Drug Administration involvement.
Senate Bill 535, approved in 2025, expands right-to-try access beyond life-threatening conditions. State regulations governing experimental treatment centres took effect July 25. Montana is the first state where sponsors of investigational new drug, or IND-stage, treatments can charge for experimental care.
To qualify under the law, a treatment must have completed an FDA Phase 1 trial. It must also receive approval from a state-registered private review board and be delivered at a state-licensed clinic. Patients must receive informed-consent information that exceeds the federal requirement, and treatment centres must report adverse events.
Phase 1 trials are an early stage of drug testing focused on safety. Only ~10% of drugs that have completed Phase 1 are ultimately approved by the FDA. Completion of that stage therefore provides limited evidence about whether a treatment will work.
Federal Right to Try and Expanded Access programmes do not permit companies to charge for experimental treatments. Montana’s law allows sponsors and clinics to charge, reducing a financial barrier for developers seeking to offer treatments before approval. Trial recruitment today has per-patient costs around $50-100k.
State Rep. Kathy Love (R–Hamilton) described the bill’s support during legislative debate, saying: “In the committee, also, the proponents were the biotech industry.”
Investors on the libertarian fringe of the biotechnology industry helped draft the legislation. Niklas Anzinger, founder of Infinita City, worked with the Alliance for Longevity Initiatives, a Virginia-based industry group, on the measure.
Infinita City is a biotechnology hub in Próspera, a Honduran special economic zone. The company in charge of the Montana board works with biotechnology firms in a zone off the coast of Honduras that has no drug regulator. Anzinger assembled Montana’s only active review board.
The ETRB functions as Montana’s version of an institutional review board, with safety review, consent requirements and mandatory outcome reporting. It cannot withhold safety information from patients. The state requires the board to include a licensed physician, a clinical outcomes researcher and an ethicist.
The company that formed the first ETRB says its model relies on review fees. It says it takes no equity in applicants and receives no payment based on outcomes. It has also set out a public conflict-of-interest policy and board biographies, publishes decision letters with an applicant’s consent, and requires annual outcome reports.
The ETRB approved its first treatment for neurological hearing loss last month. The treatment was developed by Denver-based Parley Neurotech and combines clemastine fumarate, an antihistamine already approved by the FDA for other uses, with proprietary sound therapy.
Under the authorised regimen, patients take a daily antihistamine and listen to Parley’s proprietary sound mix for 60 minutes a day. The treatment is being studied in an FDA-authorized trial elsewhere. Its approval in Montana shows how the state’s private-board system can authorise a Phase 1-cleared treatment for use at a licensed clinic.
The Montana Department of Public Health and Human Services licenses treatment centres. Centres must report serious adverse events to the department within five days. The available information does not state how many patients have accessed treatments through Montana’s clinics, what clinics charge, or the long-term safety and efficacy outcomes for patients treated outside controlled trials.
Comments (0)