MIT Technology Review is reporting that Montana has established a unique pathway for biotech companies to sell experimental drugs directly to consumers. The new legislation allows companies with drugs that have undergone preliminary testing, sometimes involving as few as 10 healthy individuals, to apply for approval from a newly formed review board for a $12,500 fee. Once approved, companies can set their own prices and sell these treatments through experimental clinics, with the first expected to open by year-end.
Unlike other "right-to-try" laws that typically limit access to terminally ill patients, Montana's law theoretically extends to anyone who provides informed consent and can pay, including those seeking treatments for rare diseases or longevity-focused preventive therapies. The state’s Department of Health and Human Services recently finalized rules for implementing the law, stipulating that patient consumers give fully informed consent and that each application be reviewed by a board including a Montana-certified doctor, expert scientists and an ethicist.
Matt Kaeberlein, a scientist on the first independent board, stressed the process would be rigorous with qualified medical professionals and appropriate oversight. However, Aaron Kesselheim, a professor of medicine at Harvard Medical School, expressed concern about the potential harm of selling unproven treatments without oversight from the U.S. Food and Drug Administration.
MIT Technology Review said the law's origin is unusual, driven by longevity enthusiasts rather than traditional libertarian or patient advocacy groups. State Sen. Ken Bogner supported expanding the law in 2023 to include all patients, focusing on preventative medicine. Tech entrepreneur and longevity enthusiast Niklas Anzinger, who previously worked on similar initiatives in Honduras, helped draft a second bill in 2025 with unnamed biotech companies, which laid out specific terms for clinics offering unapproved drugs. Anzinger's company, Infinita, established the first independent review board, the Montana ETRB, which includes oncologist James Burke, bioethicist Jessica Flanigan, and longevity experts Felipe Sierra, Matt Kaeberlein and Jamie Justice.
Initial interest in the program is coming from companies developing drugs for specific diseases, such as neuropathy and hearing loss, rather than solely longevity. Stanley Kim, CEO of WinSanTor, whose drug for peripheral neuropathy is in Phase II trials, plans to apply to make his treatment accessible and collect data. However, Thomas Joudinaud, CEO of Ceres Brain Therapeutics, expressed concern that participation could jeopardize his company's standing with the FDA. The FDA has not provided assurances beyond restating the federal Right to Try Act, and experts like Chris Robertson of Boston University caution that the FDA's stance could change with a new presidential administration.
Key differences from the FDA's expanded access program include broader patient eligibility in Montana and the ability for companies to set their own prices, unlike the FDA's cost-only model. While WinSanTor plans to sell its drug at cost, Ceres's Joudinaud hinted at market prices, which for new rare disease drugs can be high. Experts also warn that Phase I trials do not conclusively prove drug safety, with about 17% of drugs found unsafe in Phase III trials. Despite these concerns, clinics are preparing, and experimental treatments are expected to reach patients in the coming months.
Full Article: Montana’s plan to become an experimental medical hub just pushed forward