The US state of Montana took an important step on Thursday toward consolidating its plan to become a hub for experimental medicine. The expansion of the "right to try" law — the right of terminally ill patients to access treatments not yet approved by the FDA — entered a new phase, with the first therapies about to be reviewed by the committees created to examine them. In May 2025, the governor signed the law allowing clinics to offer treatments not approved by the US regulatory agency, and now the local regulatory machinery is starting to turn.
The idea behind the legislation is seductive on the surface. Patients with serious diseases and no approved options would have the chance to try something experimental, under supervision of a review board created specifically for that purpose. Proponents argue that FDA bureaucracy, however well-intentioned, costs time that terminal patients simply do not have. For them, the individual autonomy to risk one's own body should prevail over the paternalistic protection of the state.
But the Montana design goes far beyond the right of an individual patient to seek a therapy. The 2025 law created a licensing regime for "experimental treatment centers" — essentially, a commercial infrastructure to sell unapproved treatments. That is the difference between letting someone risk their own life and creating a market where companies have a financial incentive to sell products without the safety and efficacy testing that defines modern medicine. That is why the "Wild West" label stuck to the project.
The case raises a central tension that goes far beyond Montana. The history of medicine is full of treatments that seemed promising and later proved useless or harmful — and the FDA exists precisely to filter that out. At the same time, the system has real flaws: rare diseases are neglected, and terminal patients often only learn about alternatives when it is too late. "Right to try" tries to fix a legitimate pain, but in doing so, it bets that individual risk is an acceptable currency to pay for a system that still cannot distinguish hope from quackery.
The question that remains is what happens when the first death linked to one of these centers becomes a national headline — or when, on the contrary, a patient treated in Montana is cured of something official medicine considered incurable. In both scenarios, the experience will inform how other states, and perhaps other countries, view the balance between individual autonomy and regulation. Montana has become, whether it likes it or not, a laboratory experiment on the limits of liberalized medicine.
Worth noting, Montana is not an isolated case, but the most radical of a wave spreading across several US states, each with its own version of expanding access to unapproved therapies. What distinguishes the Montana model is institutionalization: it is not just about permitting, but about creating an ecosystem with licensed centers and review boards, which gives a veneer of legitimacy to a process that elsewhere is treated as a one-off exception. Supporters see in it the democratization of access; critics, a dangerous loosening of the safety standards that protect precisely the most vulnerable patients. The truth probably lies somewhere in between — which is why Montana works so well as a case study of what happens when a society chooses to prioritize individual autonomy over regulatory consensus.
Sources: MIT Technology Review, Duane Morris, LifeSpan.io, NBC Montana
✓ Independent sources cross-checked and verified before publishing
