TECH Signal 402
Montana expands right-to-try program to allow experimental therapies for any medical condition
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Montana has approved its first experimental therapy for hearing loss under a new law that lets patients bypass FDA approval for any condition.
The program shifts the risk of experimental treatment from federal regulators to patients and private review boards. It removes the federal restriction on company profits, potentially incentivizing biotech firms to offer therapies outside traditional clinical trial paths.
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Patients with any condition can access experimental therapies that have passed Phase 1 trials.
Companies are permitted to charge any price for treatments provided through state-licensed centers.
The program requires informed consent, a provider recommendation, and approval from a private review board.
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Montana's Senate Bill 535 expands the scope of the federal Right to Try Act. While the federal version is limited to patients with life-threatening conditions, the state law opens access to any patient regardless of their condition. This change allows for the administration of therapies like the recently approved sound-and-antihistamine regimen for hearing loss.
The cost of adoption for companies is lowered by removing the requirement for full FDA approval, which proponents argue stifles competition. Unlike the federal program, Montana allows companies to profit from these experimental treatments. This financial incentive aims to address the low participation rates seen in the federal program, where only 27 products were offered between 2018 and 2025.
The program stops working as a guaranteed safe harbor due to the threat of federal enforcement. A group including biotech companies and patient advocates has requested assurances from the FDA that the agency will not take action against them, but has not received a definitive response. This creates a legal tension between state-level access and the FDA's nationwide monopoly on marketing and sales.
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