Montana has finalized rules allowing consenting adults to access experimental drugs, including longevity therapies, through a new private review board process.
Key facts
- •Montana's law allows any consenting adult to purchase experimental drugs, unlike other jurisdictions that limit access to terminally ill patients.
- •The first experimental treatment review board is a private entity run by Montana Governance Services Inc.
- •Biotech companies must pay a $12,500 fee per application to have their drugs reviewed for potential sale in Montana clinics.
- •Two applications have already been submitted to the review board for treatments targeting neuropathy and hearing loss.
- •The FDA has declined to provide assurances that companies participating in the state program will not face future regulatory consequences.
Montana has finalized regulations for a state law that allows adults to access experimental drugs without FDA approval. The program, which is broader than traditional right-to-try laws, permits consenting patients to purchase treatments for various conditions, including longevity-focused therapies. Biotech companies can now apply for approval through a private review board to sell these drugs at clinics within the state.
By the numbers
Regulatory Framework and Oversight
The state’s Department of Health and Human Services finalized rules for the program in July 2025. To participate, biotech companies must submit applications to a review board and pay a $12,500 fee. The first board, known as the Montana ETRB, is a private service operated by Montana Governance Services Inc., an entity under the umbrella of the organization Infinita. The board consists of five members, including an oncologist, a bioethicist, and three experts in aging and longevity research.
Industry Participation and FDA Concerns
While some companies, such as WinSanTor, have submitted applications to provide treatments for conditions like peripheral neuropathy, others remain hesitant. Biotech executives have expressed concern that participating in the Montana program could negatively impact their standing with the U.S. Food and Drug Administration. The FDA has not provided formal assurances to companies regarding potential penalties, stating only that it does not comment on state legislation.
Timeline
- 2015Montana passed its initial right-to-try legislation.
- 2023The state expanded the right-to-try law to include all patients, not just those with terminal diseases.
- April 2025Legislation outlining terms for clinics to offer unapproved drugs was passed.
- July 25, 2025Rules for the treatment centers became effective.
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This article was independently rewritten by ManyPress editorial AI from reporting originally published by MIT Technology Review.
