Montana has passed a landmark bill enabling licensed medical clinics to recommend and sell experimental therapies that have not received approval from the Food and Drug Administration (FDA). Once signed by Governor Greg Gianforte, the law will become the most permissive in the United States for access to unproven drugs that have only completed phase I clinical trials—initial studies primarily focused on safety rather than effectiveness. The bill was designed with strong support from longevity advocates, libertarians, scientists, and influencers intent on extending human lifespan and positioning Montana as a center for medical innovation and tourism.
This legislation builds on Montana’s earlier Right to Try law, which originally permitted only terminally ill patients to access experimental treatments but was expanded in 2023 to all residents. However, regulatory gaps left clinics unable to provide such services, prompting the need for more precise legal infrastructure detailing licensing, consent, and operational requirements for experimental treatment clinics. Clinics will be required to obtain annual licenses and adhere to stricter informed consent measures, ensuring patients are informed of available alternatives and potential risks. The bill aims not only to retain the financial and medical benefits within the US but also to offer Americans alternatives to costly and controversial treatments available abroad, such as unapproved stem cell and gene therapies.
Nevertheless, the move has sparked significant ethical and legal controversy. Critics argue that phase I trials are too limited in scope to assure safety or efficacy, with high failure rates and a history of adverse outcomes from prematurely released drugs. Bioethicists and legal scholars warn that making unproven drugs widely accessible could endanger patients and undermine standards dating back to important historical safeguards. Questions remain over the fairness of making individuals pay for treatments with unknown benefits and the provision requiring treatment centers to allocate a portion of profits to local access, which some fear could expose vulnerable populations to untested therapies. Despite the debate, several clinics are preparing to open in Montana, encouraged by the state’s existing pharmaceutical infrastructure and promises of looser federal oversight on in-state drug production. Proponents hope Montana’s model will spread to other states and set a national precedent for medical autonomy and innovation.
