Montana's Experimental Treatment Law Moves From Paper to Practice as First Review Board Forms

A Law Ten Years in the Making Just Got Its Operating Manual

Montana finalized the implementing rules for Senate Bill 535 earlier this month, according to lifespan.io. The state's new category of medical facility, the experimental treatment center, can now actually open for business.

This didn't happen overnight. Montana passed its first right-to-try law back in 2015, limited to terminal patients trying drugs that had cleared Phase 1 trials. Congress followed with a federal right-to-try law in 2018. Then in 2023, State Senator Ken Bogner pushed through SB 422, which dropped the terminal-illness requirement entirely, according to lifespan.io. Patients only had to have "considered all" FDA-approved options first, not exhausted them.

SB 422 was a big swing, but it left a hole: no framework for actually opening a clinic to deliver these treatments. SB 535, signed by Governor Greg Gianforte in May and reported at the time by longevity.technology, filled that gap. It passed the legislature narrowly in 2025, according to lifespan.io, and created licensed "experimental treatment centers" plus independent "experimental treatment review boards" (ETRBs) to vet the therapies before patients get them.

Who's Actually Running the First Board

The first mover is Infinita, founded by Niklas Anzinger, which announced what it calls the first registered Montana ETRB, according to longevity.technology. The board includes researchers with real standing in aging science: Matt Kaeberlein, Felipe Sierra, Jamie Justice, Jessica Flanigan and James M. Burke.

Stephen Martin, whose organization is also moving to get board members' credentials submitted, called it a milestone in a LinkedIn post cited by longevity.technology. "After more than a year of waiting, it's finally here," he wrote, adding that protocol reviews could start "as early as next week." He described months of talking to "policy makers on the Hill and regulators at the FDA" and sourcing treatment options from biotech companies.

Under the law, the review board's job is narrowly about safety. Treatments have to show a safety profile consistent with a completed Phase 1 trial, and patients must be informed of the risks before they consent, according to longevity.technology.

The Case for It: The FDA Is Slow and Expensive, and Sick People Are Waiting

An op-ed carried by the Independent, dated July 29, 2026, lays out the argument driving this whole movement. A gene therapy takes 12 to 15 years to win FDA approval on average, the piece states, partly because the agency struggles to write rules for treatments built for a single patient. Zolgensma, the gene therapy for spinal muscular atrophy, costs $2.1 million per dose. One estimate cited in the piece puts the cost of moving a single gene therapy through approval at nearly $5 billion, or roughly $1 million per trial participant.

Those costs don't stay abstract. Insurers balk at seven-figure treatments, doctors stop recommending them, and patients go without a therapy that isn't broken, just priced out of reach, the Independent piece argues.

The movement traces back to Abigail Burroughs, who died of head and neck cancer in 2001 after being denied access to an experimental drug her oncologist thought could help, according to the Independent. Her father founded the Abigail Alliance and sued for a patient's right to try unapproved treatments. He lost in court, but the cause became right-to-try, and it eventually became federal law in 2018.

The Independent also cites Ted Harada, an ALS patient told an experimental procedure wouldn't help him. He tried it anyway under Georgia's right-to-try law and saw his symptoms reverse. Not every patient gets that outcome, the piece acknowledges, but some genuinely did get chances the standard system would have denied them.

The Fair Question Nobody's Fully Answered Yet

A skeptic would raise a reasonable concern: these treatments have only cleared Phase 1, the smallest and least conclusive stage of clinical testing, typically designed to check for basic safety in a handful of people, not effectiveness. SB 535 also lets these centers charge patients directly, including in crypto, which raises the obvious question of financial incentive shaping medical judgment.

None of the three sources here report any FDA action, state investigation, or enforcement dispute tied to Montana's law. No charges, no injunctions, nothing pending. That's not evidence the system is being abused, but it's also not evidence the review boards are working as intended, because the boards have barely started operating. Infinita's ETRB was only just registered, and Martin's group hadn't yet begun reviews as of the reporting from longevity.technology.

The people sitting on these boards are credentialed scientists, not fringe operators. But the boards are new, self-organized, and reviewing treatments that traditional FDA trials haven't yet finished vetting for effectiveness. Whether Montana's safety-only review standard holds up once real patients start paying real money for unproven therapies is an open question, because the first reviews haven't happened.

What Happens Next

Martin said his group aims to begin protocol reviews within days of the rules taking effect. Infinita's board is expected to start evaluating Phase 1-cleared therapies for use in Montana's licensed clinics. Whether other states copy Montana's model, and whether the FDA responds at all, remains unresolved.