Key facts
- Montana has enacted a law allowing biotech companies to sell experimental drugs.
- A privately run board will review applications for drug approval.
- Companies can pay $12,500 to apply for review of their experimental drugs.
- The first authorized treatment is for hearing loss, involving an antihistamine and sound therapy.
- The law expands access beyond terminal illnesses to anyone who gives informed consent and can pay.
- Experts express concerns about potential harm from selling unproven treatments without FDA oversight.
Montana is emerging as a hub for experimental medical treatments following the enactment of a new law that grants biotech companies broad authority to sell unapproved drugs to consumers. The legislation, driven by longevity enthusiasts and supported by state senator Ken Bogner, allows companies to apply to a privately run review board for approval of their experimental therapies. This bypasses the rigorous oversight of the U.S. Food and Drug Administration (FDA).
The application fee for companies is $12,500. Once a treatment is approved by the board, which includes a Montana-certified doctor, expert scientists, and an ethicist, the company can set its own price and sell it through experimental treatment clinics. The first such clinic is expected to open by the end of the year.
The first treatment authorized under this new framework is for hearing loss. It involves patients taking a daily antihistamine and listening to a proprietary sound mix for 60 minutes a day. This approach has raised concerns among medical experts like Aaron Kesselheim, a professor at Harvard Medical School, who worry about the potential for harm when unproven treatments are sold without FDA oversight, especially in an industry prone to unfounded claims.
Unlike similar "right to try" laws in other states that often limit access to patients with terminal illnesses, Montana's law theoretically makes experimental drugs available to anyone who provides informed consent and can afford the treatment. This includes individuals seeking cures for rare diseases, as well as those interested in longevity and preventive therapies. The law's origin is unique, having been significantly influenced by the Alliance for Longevity Initiatives (A4LI), a nonprofit focused on increasing healthy human lifespan.
One parent, Kris DeVault, is particularly hopeful about the law. His three-year-old son, Brody, suffers from creatine transporter deficiency, a rare genetic disease with no known cures. DeVault is seeking an experimental drug being developed by Ceres Brain Therapeutics, which has shown promising results in animal and early human trials. The company's CEO, Thomas Joudinaud, stated that the drug is designed to bypass the issue of creatine not entering the brain.