Montana Is Trying To Break the FDA's Monopoly on Experimental Treatments

Montana’s expanded right-to-try program has cleared its first therapy: a sound-and-antihistamine regimen to reverse hearing loss.

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.

​Proponents of the program argue that the expensive costs of the FDA approval process stifle competition, drive up costs, and prevent potentially beneficial treatments from reaching patients. 

Niklas Anzinger, founder of Infinita City, a biotech hub in the Honduran special economic zone Próspera, worked with the Alliance for Longevity Initiatives, a Virginia-based industry group, to draft the law and assembled the only active review board. Anzinger described the program on the Stranded Technologies Podcast as one that could offer "a potential paradigm change in how we do science instead of top-down, more bottom-up, but still in a controlled way with oversight and everything."

Anzinger argues that by freeing small companies from having to conduct costly clinical trials, Montana's system will give patients cheaper costs and access to therapies that they wouldn't have otherwise had. According to Politico, he told lawmakers that by passing the law, Montana "would no doubt have the potential to become the world's leader in accelerating patient access to innovative, potentially life-saving treatments."

Not everyone is as optimistic. Many ethicists and legislators are concerned about the lack of oversight and level of commercial involvement.

​During debate over the bill, state Rep. Kathy Love (R–Hamilton) questioned whose interests it served. "In the committee, also, the proponents were the biotech industry," Love said. "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 thing they set up in Montana is really a program to facilitate access to anybody and everybody who wants it, to novel experimental interventions for anything."

Caplan compared the program to a prediction market rather than medical research. ​

"It's like, you want to gamble? OK, go ahead."

​Caplan inadvertently made a useful analogy. Montana's program is like a prediction market: It lets people evaluate all the market's options and decide based on their own judgment.

​Regulating drugs is also a gamble. The regulator gambles that they will help patients by restricting harmful drugs more than they hurt them by limiting access to beneficial drugs or discouraging their production altogether. The question is: Who gets to gamble with the patient's health? The patient or the regulator?

The Federal Right to Try program was intended to remedy this problem by giving terminally ill patients access to experimental therapies, but the program has hardly lived up to its promise. The FDA's latest report shows that from 2018 to 2025, companies have offered a grand total of only 27 products through the program and just six 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 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 request assurance that the agency would not take action against them in Montana. The group didn't receive a definitive response, according to Business Insider.

Montana's program broadens patient choice and provides increased incentive for companies to participate, but as the federal program demonstrated, creating a framework for a drug to be offered is only half the battle.

​The gap in patient access ultimately comes down to the FDA's monopoly on who gets to market and sell nationwide, and that can't be fully rectified through state programs. "Montana can remove barriers that prevent patients from accessing experimental treatments, but it cannot remove the FDA's regulatory shadow," Singer tells Reason.