Montana's expanded right-to-try law takes effect, opening drugs to anyone

Montana's expanded right-to-try law became operational this week after the state's Department of Health and Human Services finalized the rules needed to implement it. Under the law, a biotech company whose drug has passed preliminary testing, sometimes in as few as 10 healthy people, can pay $12,500 to apply to a newly formed review board for approval. Once approved, the company can set its own price and sell the drug through experimental treatment clinics, the first of which is expected to open around the end of the year. Unlike right-to-try laws in other states, which restrict access to people with terminal illness, Montana's version is open in theory to anyone who gives informed consent and can pay, including patients seeking treatments for rare diseases and people interested in longevity or preventive therapies.

The law traces back to a 2015 Montana right-to-try statute. In 2023, with backing from state senator Ken Bogner, it was expanded to cover all patients rather than only the terminally ill; Bogner has said his goal was to focus on preventive medicine rather than treating disease after the fact. The nonprofit Alliance for Longevity Initiatives helped draft that 2023 bill. Tech entrepreneur and longevity enthusiast Niklas Anzinger, who is based in the Próspera special economic zone in Roatan, Honduras, then worked with a group of unnamed biotech companies to draft a second bill spelling out the specific terms under which clinics could offer unapproved drugs. That law passed in April 2025 and was adopted the following month, and its implementing rules took effect on Saturday, July 25, 2026.

With the rules in place, Anzinger and Stephen Martin, the US lead for Anzinger's company Infinita, set up the state's first review board, the Montana ETRB, a panel of five experts. Infinita pays board members a flat fee funded by the $12,500 application fee, though Anzinger says the board and its decisions are independent of Infinita. The board includes a Montana-licensed doctor, oncologist James Burke; a bioethicist, Jessica Flanigan, author of Pharmaceutical Freedom; and three figures from the longevity field: Felipe Sierra, a former senior official at the National Institutes of Health's aging division and later chief scientific officer at Hevolution Foundation; Matt Kaeberlein, who formerly led the Dog Aging Project and has studied rapamycin as a longevity therapeutic; and Jamie Justice, a gerontologist and executive director of the X Prize Healthspan competition, which offers $101 million in prize money for aging research.

Two applications have already reached the board, both from companies developing treatments for neuropathy and hearing loss, according to Martin. One came from Stanley Kim, CEO of WinSanTor, whose drug for peripheral neuropathy is in phase II trials; Kim says he hears regularly from desperate patients and hopes access through Montana will also let him collect data that could help the drug's formal approval process. His company's newsletter reaches about 15,000 patients. Not every company is rushing in: Thomas Joudinaud, CEO of French biotech Ceres Brain Therapeutics, has fielded a request to make his company's experimental drug available in Montana but is holding off, worried that any problem there could damage his standing with the FDA.

The FDA itself has stayed largely silent. Asked for assurance that participating companies won't be penalized later, the agency has offered only a restatement of the federal Right to Try Act, and a spokesperson told MIT Technology Review that, as a matter of policy, it does not comment on state legislation. Health law specialist Chris Robertson of Boston University cautions that the FDA's current posture could shift under a new presidential administration. He and others suggest that companies wanting to stay in the FDA's good graces are safer using the agency's existing expanded-access pathway for seriously or terminally ill patients, which the FDA approves in over 99% of cases and which the agency says takes less than 45 minutes to fill out.

Key facts

• Montana's finalized rules let a company pay $12,500 to seek approval to sell an experimental drug that has passed only preliminary testing, sometimes in as few as 10 healthy people.
• Unlike other right-to-try laws, Montana's version is open to anyone who gives informed consent and can pay, not just the terminally ill.
• The first review board, the Montana ETRB, is a five-member panel organized by Niklas Anzinger's company Infinita; it has already received two applications, for neuropathy and hearing-loss treatments.
• WinSanTor CEO Stanley Kim, whose peripheral-neuropathy drug is in phase II trials, is one applicant; his patient newsletter reaches about 15,000 people.
• The FDA has offered no assurance that companies using Montana's pathway will be protected later, and experts including Chris Robertson and Aaron Kesselheim warn of risk and uncertainty.

Why it matters

Montana just became the first US state where access to an unapproved drug does not require being terminally ill: a company can get a drug cleared for sale after only preliminary testing, and any consenting adult who can pay can buy it. That is a meaningfully different model from the federal expanded-access pathway and from other states' right-to-try laws, both of which are aimed at people who have run out of options.

Who it affects

Biotech companies with early-stage drugs now have a new US route to revenue and real-world data years before FDA approval. Patients with rare diseases, cancer, or neurodegenerative conditions, and people pursuing longevity or preventive therapies, gain a legal way to buy treatments the FDA has not vetted. The law also affects the review board members themselves, who are paid by Infinita out of the application fees, and the FDA, which is being asked, so far without success, to say whether participation will carry consequences later.

How to use it

A company applies to the Montana ETRB with a drug that has cleared preliminary testing and pays $12,500 for review. If approved, the company sets its own price and sells the drug through experimental treatment clinics, the first of which is expected to open around the end of 2026. Patients must give informed consent and meet the program's requirements; two applications, for neuropathy and hearing-loss treatments, are already before the board and review is expected to start this week.

How solid is it

The law and its implementing rules are real and now in effect, having been finalized by Montana's Department of Health and Human Services and taking effect July 25, 2026. The review board is operating, with named members holding stated credentials (an oncologist, a bioethicist, and three longevity-field figures with verifiable prior roles). What is not yet demonstrated is outcomes: no drug has been approved or sold under the new rules yet, and the two pending applications have not been decided.

Risks and caveats

Critics including Harvard's Aaron Kesselheim worry about selling unproven treatments without FDA oversight. The FDA has declined to say whether companies using Montana's pathway will be shielded from consequences later, and Boston University's Chris Robertson notes the agency's position could change under a future administration, which is why at least one company, Ceres Brain Therapeutics, is holding off on applying. The board that reviews applications, while described as independent, is organized and funded through fees channeled by Infinita, the same longevity-focused company that helped draft the underlying law.

“I would be concerned”

— Aaron Kesselheim, professor of medicine at Harvard Medical School