Montana has finalized state health department rules that establish a pathway for biotechnology companies to provide experimental drugs to patients outside of traditional federal oversight. Under the new framework, companies with drugs that have undergone preliminary testing—in some cases involving as few as 10 healthy individuals—can apply for approval through a private review board. Once authorized, these firms may set prices and distribute treatments through specialized clinics, with the first facilities expected to open by the end of the year.

Unlike federal "right to try" laws that typically restrict access to terminally ill patients, Montana’s legislation allows any individual who provides informed consent and pays the associated costs to access these treatments. This includes those seeking interventions for rare diseases as well as individuals interested in preventive or longevity-focused therapies. The application process requires a $12,500 fee, which funds an independent review board composed of a Montana-licensed physician, scientists, and an ethicist.

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The initiative has been heavily influenced by the Alliance for Longevity Initiatives and tech entrepreneur Niklas Anzinger, who previously worked on similar projects in Honduras. While supporters argue the process provides a rigorous, transparent alternative for those seeking early access to medical innovation, critics remain skeptical. Experts like Harvard Medical School professor Aaron Kesselheim have expressed concern regarding the lack of US Food and Drug Administration (FDA) oversight, warning of potential risks to patients and the possibility that participation could jeopardize a company’s standing with federal regulators.

Some biotech firms, such as WinSanTor, have already submitted applications for treatments targeting conditions like peripheral neuropathy, viewing the program as a way to provide relief and collect valuable data. Others remain cautious, citing potential regulatory friction with the FDA. The federal agency has declined to comment on the state legislation, maintaining that its own expanded-access programs already provide a safe, established route for patients with serious illnesses to obtain unapproved treatments.

Source: MIT Technology Review