Montana has created a new route for biotech companies to sell experimental drugs directly to consumers, sidestepping federal oversight. The state finalized rules this week that let firms apply for approval through a newly established review board without requiring patients to be terminally ill.
Applications cost $12,500. Once approved, companies set their own prices and distribute treatments through clinics expected to open by the end of the year. The review board includes a Montana-certified doctor, expert scientists, and an ethicist.
How the system works
The 2023 state law expanded an earlier right-to-try statute by removing the terminal diagnosis requirement. Now, anyone who provides informed consent and can pay may access treatments that have completed only preliminary testing, sometimes involving as few as 10 healthy volunteers.
Applications go to the review board, which was formed independently of the state health department. One member, Matt Kaeberlein, a scientist on the board, believes the system provides oversight. “It will be done in a very rigorous way, with qualified medical professionals and appropriate oversight,” he says.
Critics warn the approach may expose patients to unnecessary risks. Aaron Kesselheim, a Harvard professor specializing in drug regulation, called the lack of FDA oversight troubling. “I would be concerned,” he said.
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A business model for unproven treatments
The law originated with longevity advocates rather than traditional patient-rights groups. Niklas Anzinger, a tech entrepreneur and longevity enthusiast, got involved after the 2023 expansion. He has been working to establish a jurisdiction to fast-track the search for drugs that might deliver radical life extension. Anzinger is based in Próspera—a private city and special economic zone in Roatán, Honduras, which is already home to a separate clinic that sells experimental stem-cell and gene therapies. He founded a community there called Infinita City; he has also founded an investment company and a service-providing company, both of which include the name Infinita.
Over the last couple of years, Anzinger has switched his focus to the US. “Now we think that Montana is a better model, because it’s building on … existing regulatory precedents,” he says. Once Montana’s 2023 law was passed, he worked with others to draft a second bill—one that laid out the specific terms under which clinics can offer unapproved drugs. That law was passed in April 2025.
Supporters of the law stress that they want the process to be responsible, though other experts are worried about the potential for harm in selling unproven treatments to people without oversight from the US Food and Drug Administration.
The state’s approach shows a growing effort to make unproven therapies more available, though Montana’s model is notable for its breadth. Its success or failure may influence other states considering similar paths.
Tech firms are also competing for specialized talent as demand for advanced treatments grows.
