As Americans face rising healthcare costs, Montana is offering a novel right-to-try program that lawmakers hope will bring relief to consumers in the state. The program allows patients with any condition to bypass the Food and Drug Administration (FDA) approval process and access experimental therapies. Last month, the program approved its first treatment for hearing loss, but the looming threat of federal enforcement could derail the experiment.
The federal Right to Try Act, signed by President Donald Trump in his first term, allows patients with life-threatening conditions to access experimental therapies that have passed Phase 1 of clinical trials. Last year, the Montana Legislature passed Senate Bill 535, which expanded that access to any patient, regardless of condition, offering treatment through state-licensed centers. Unlike the federal program, which bars companies from profiting, Montana's law allows companies to charge what they like. As long as the treatment has cleared Phase 1, has been approved by a private review board, the patient gives informed consent, and a provider recommends it, they can access it.
