Montana advances new route for experimental drug sales

Montana has finalized rules for an expanded right-to-try system that could let biotech companies sell experimental drugs to consumers through treatment clinics. Unlike similar laws elsewhere, access is not limited to terminally ill patients and could include people seeking preventive or longevity-focused interventions, as long as they provide informed consent and can pay.

The effort grew out of Montana’s earlier right-to-try laws in 2015 and 2023, with major involvement from longevity advocates including Infinita founder Niklas Anzinger and state senator Ken Bogner. Infinita has announced the first private review board, Montana ETRB, made up of a Montana-licensed doctor, scientists, and a bioethicist. Board members including Matt Kaeberlein and Jamie Justice say the process can add scientific rigor, oversight, and data collection.

Two applications have already been submitted, including one from WinSanTor for a peripheral neuropathy treatment in phase II trials and another involving hearing loss. Some companies remain cautious because the FDA has not offered assurances that participation will not affect future approvals. Critics including Harvard’s Aaron Kesselheim argue the FDA’s expanded-access pathway already approves over 99% of requests and can be completed in less than 45 minutes, while warning that early trials do not prove safety. Around 17% of drugs are found to be inadequately safe during phase III trials.