Montana’s broadened right-to-try program has approved its inaugural therapy: a regimen combining a sound-based intervention with an antihistamine to reverse hearing loss.
Amid rising costs in American healthcare, the state of Montana is introducing a novel right-to-try framework designed to offer relief to residents. The policy permits patients with any condition to bypass the Food and Drug Administration (FDA) review process and obtain access to experimental therapies. A month ago, the program sanctioned its first treatment for hearing loss, but the threat of federal enforcement looms and could undermine the venture.
The federal Right to Try Act, signed by President Donald Trump during his first term, enables patients with life-threatening diseases to pursue experimental therapies that have cleared Phase 1 of clinical testing. Last year, the Montana Legislature enacted Senate Bill 535, which broadened that access to any patient, regardless of diagnosis, providing treatment through centers licensed by the state. In contrast to the federal scheme, which prohibits profit, Montana’s law permits companies to set their prices freely. As long as the treatment has cleared Phase 1, has been approved by an independent review board, the patient provides informed consent, and a clinician recommends it, access is possible.
Advocates argue that the expensive FDA approval process stifles competition, raises costs, and keeps potentially beneficial therapies from reaching patients.
Niklas Anzinger, founder of Infinita City, a biotech hub located in Próspera, the Honduran special economic zone, collaborated with the Alliance for Longevity Initiatives, a Virginia-based industry association, to draft the law and assemble the only active review board. Anzinger described the program on the Stranded Technologies Podcast as potentially representing a shift in how science is conducted—moving away from a top-down model toward a more bottom-up approach, yet still conducted under oversight and safeguards.
Anzinger maintains that by freeing small companies from the burden of costly clinical trials, Montana’s system could reduce patient costs and broaden access to therapies they otherwise would not obtain. According to Politico, he told lawmakers that enacting the statute would likely position Montana “as a world leader in accelerating patient access to innovative, potentially life-saving treatments.”
Not everyone shares this optimism. A number of ethicists and lawmakers worry about the lack of oversight and the extent of commercial involvement.
During the Bill’s debate, state Rep. Kathy Love (R–Hamilton) questioned whose interests were being served. “In the committee, the proponents were the biotech industry,” Love remarked. “It was not private citizens.”
Arthur Caplan, former head of the division of medical ethics at New York University Grossman School of Medicine, told Business Insider, “This arrangement in Montana appears to be a program designed to facilitate access to anyone seeking novel experimental interventions for any condition.”
Caplan compared the program to a prediction market more than to traditional medical research.
“If you want to gamble, go ahead.”
Caplan’s remark unexpectedly offers a useful analogy. Montana’s program resembles a prediction market: it enables people to weigh all available options and decide based on their own judgment.
Regulating drugs is also a gamble. The regulator bets that restrictions will protect patients by curbing dangerous drugs more than they hinder access to beneficial ones or discourage development. The central question becomes: who should gamble with the patient’s health? The patient or the regulator?
The Federal Right to Try program was created to address this dilemma by giving terminally ill patients access to experimental therapies, but it has not lived up to its promise. The FDA’s most recent report shows that from 2018 to 2025, companies offered a total of only 27 products through the program, with merely six of them released last year.
As Jeffrey A. Singer, a practicing surgeon and senior fellow at the Cato Institute, wrote for Reason earlier this year, “Companies often decline participation because of cost, liability concerns, and the risk that adverse outcomes could complicate approval.”
“Meanwhile,” Singer added, “because the FDA still controls final approval, companies have strong incentives to avoid anything that might jeopardize it.”
In June, “a group that included Infinita, patient advocates, and biotech companies” met with FDA officials to seek assurances that the agency would not take action against them in Montana. The group did not receive a definitive response, according to Business Insider.
Montana’s program broadens patient choice and provides greater incentives for companies to participate, but as the federal program demonstrated, simply establishing a framework for a drug to be offered is only half the battle.
The gap in patient access ultimately stems from the FDA’s monopoly on who can market and sell nationwide, a constraint that cannot be fully overcome through state programs. “Montana can remove barriers that prevent patients from accessing experimental treatments, but it cannot erase the FDA’s regulatory reach,” Singer told Reason.
