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.
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lawmakers → face → state
The program allows patients with any condition to bypass the Food and Drug Administration (FDA) approval process and access experimental therapies.
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patients → allow → therapies
Last month, the program approved its first treatment for hearing loss, but the looming threat of federal enforcement could derail the experiment.
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threat → approve → 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.
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that → try → 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.
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which → pass → centers
Unlike the federal program, which bars companies from profiting, Montana's law allows companies to charge what they like.
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they → bar → what
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.
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they → clear → 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.
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costs → argue → 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.
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Anzinger → work → 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."
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we → describe → oversight
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.
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they → argue → that
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."
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Montana → accord → treatments
During debate over the bill, state Rep. Kathy Love (R–Hamilton) questioned whose interests it served.
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it → question → interests
"In the committee, also, the proponents were the biotech industry," Love said.
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Love → say → committee
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."
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who → tell → anything
Caplan compared the program to a prediction market rather than medical research.
"
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Caplan → compare → research
It's like, you want to gamble?
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you → want → ?
Caplan inadvertently made a useful analogy.
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Caplan → make → 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.
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people → let → judgment
Regulating drugs is also a gamble.
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Regulating → regulate → drugs
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.
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they → gamble → production
The question is: Who gets to gamble with the patient's health?
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Who → get → 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.
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program → try → 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.
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companies → show → program
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."
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outcomes → practice → approval
"Meanwhile," Singer added, "because the FDA still controls final approval, companies have strong incentives to avoid anything that might jeopardize it."
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that → add → 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.
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agency → include → Montana
The group didn't receive a definitive response, according to Business Insider.
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group → receive → 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.
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drug → broaden → framework
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.
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that → come → programs
"Montana can remove barriers that prevent patients from accessing experimental treatments, but it cannot remove the FDA's regulatory shadow," Singer tells Reason.
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Singer → remove → Reason
The Aporia
