Montana’s push to become an experimental medical hub accelerated this week as a newly formed private review board began accepting applications for unapproved drugs. Driven by state lawmakers and longevity advocates, the framework allows patients to access experimental therapies with informed consent, bypassing traditional U.S. Food and Drug Administration clearance despite sharp warnings from federal regulators and health policy experts.
The Regulatory Blueprint Behind Montana’s Experimental Clinics
Under rules finalized by the state’s Department of Health and Human Services, firms with drugs that have cleared preliminary testing—sometimes in as few as 10 healthy individuals—can pay a $12,500 fee to apply for board review. Once approved by a review panel, these companies can set their own prices and distribute treatments through specialized experimental clinics. The first of these clinics is expected to open by the end of this year.
This decentralized approach builds on a legislative trajectory that began with a standard right-to-try law in 2015. State Senator Ken Bogner spearheaded a 2023 expansion to include all patients rather than only those with terminal conditions, shifting the focus toward preventive medicine. Tech entrepreneur and longevity enthusiast Niklas Anzinger subsequently collaborated with lawmakers to draft operational guidelines, culminating in a specialized framework adopted in May 2025.
To oversee applications, Anzinger and Stephen Martin, Infinita’s U.S. lead, established the Montana Experimental Treatment Review Board (ETRB) under the umbrella of local entity Montana Governance Services Inc. The board operates independently of the state health department, funded by application fees. In accordance with state rules, the five-member panel features oncologist James Burke, bioethicist Jessica Flanigan, and prominent longevity figures Felipe Sierra, Matt Kaeberlein, and Jamie Justice.
Diverging Priorities: From Rare Diseases to Radical Longevity
While the legislative framework was heavily shaped by life-extension advocates, initial applications are targeting specific, debilitating medical conditions. According to Anzinger, early interest has emerged primarily from companies developing treatments for oncology and neurodegenerative disorders.
The newly formed board has already received submissions from two biotech firms. One application was filed by WinSanTor CEO Stanley Kim for a peripheral neuropathy treatment currently in phase II trials. Kim noted that the pathway could offer relief to desperate patients while generating valuable real-world data to accelerate formal drug approval. WinSanTor plans to price its treatment at cost.
Other developers remain cautious. Ceres Brain Therapeutics CEO Thomas Joudinaud acknowledged the pragmatism of the Montana model but confirmed his company will not apply immediately, citing risks to its standing with the FDA. Unlike the federal agency’s expanded-access program—which approves over 99% of applications for seriously ill patients at cost-based pricing—Montana’s framework permits market-rate pricing for unapproved interventions.
Federal Pushback and Safety Concerns
The initiative has drawn intense scrutiny from medical and legal scholars. Harvard Medical School professor Aaron Kesselheim expressed concern over the deployment of unproven treatments without federal oversight. Critics emphasize that phase I studies do not definitively establish safety, noting that approximately 17% of drugs fail safety evaluations during rigorous phase III trials.
Federal authorities have declined to offer immunity or specific guidance to participating manufacturers. An FDA spokesperson stated that the agency does not comment on state legislation, resting its position on the federal Right to Try Act. Boston University health law specialist Chris Robertson warned that current federal assurances offer little long-term protection, noting that regulatory stances can shift across presidential administrations.
Despite these uncertainties, treatment facilities are actively outfitting rooms and hiring medical directors. With the Montana ETRB operational and review processes underway, commercial access to unapproved therapies in the state is poised to move from legislative theory to clinical reality in the coming months.
