Montana has officially moved forward with a unique "right to try" framework that permits biotech companies to sell experimental drugs directly to consumers. Following the finalization of state health department rules, companies with treatments that have undergone preliminary testing—sometimes in as few as 10 healthy individuals—can now apply for approval through a private review board. Once authorized, these firms may set their own prices and distribute treatments via experimental clinics, with the first facilities expected to open by the end of 2026.
Unlike federal "right to try" laws that typically restrict access to terminally ill patients, Montana’s legislation allows any individual to access unapproved drugs, provided they offer informed consent and can afford the treatment. This scope includes those seeking preventive therapies for longevity as well as patients with rare diseases. To oversee this process, a private entity under the Infinita umbrella has established the Montana Experimental Treatment Review Board. This panel, which charges a $12,500 application fee, includes a Montana-licensed oncologist, a bioethicist, and several prominent figures from the longevity research community.
The initiative has drawn mixed reactions. Proponents, including state senator Ken Bogner and longevity advocates, argue the program provides a rigorous, transparent pathway for accessing potentially life-extending or disease-treating interventions. Two applications have already been submitted for drugs targeting neuropathy and hearing loss. However, medical experts, including Harvard Medical School professor Aaron Kesselheim, have expressed concerns regarding the lack of US Food and Drug Administration (FDA) oversight and the potential for patient harm.
Some biotech firms remain hesitant to participate, fearing that involvement in the Montana program could negatively impact their standing with the FDA. While the agency maintains that it does not comment on state legislation, legal experts warn that companies seeking to maintain federal approval for their products may find the FDA’s existing "expanded access" program a safer, more established route for providing experimental treatments to patients.
Source: MIT Technology Review
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