Montana's right-to-try law enters a new review phase
Montana's right-to-try law enters a new operational phase after the state formed its first experimental treatment review board, which can now evaluate therapies for a $12,500 fee. Longevity figures Matt Kaeberlein, Jamie Justice, and Felipe Sierra join the five-member panel, signaling a middle path between unregulated clinics and slow federal approval.
Key Takeaways
- Montana's first experimental treatment review board (ETRB) is live under rules that took effect earlier this month.
- Developers can submit eligible therapies for review for a $12,500 fee; most will have completed Phase I.
- Board approval is not FDA approval and confers no federal legal status.
- SB 422 (2023) dropped the terminal-illness limit; SB 535 (2025) created experimental treatment centers.
- Annual public summaries must cover reviews, safety outcomes, serious adverse events, and timelines.
For readers following longevity and biohacking policy, Montana is trying to build a regulated onshore option instead of pushing patients toward medical tourism or unlicensed clinics.
What just changed in Montana's right-to-try framework?
Under final rules that took effect earlier this month, an experimental treatment center must establish or contract with an ETRB. Board members may have no conflicts of interest involving the centers they review.
According to Lifespan.io's report, the first five-member board is now formed. Besides Kaeberlein, Justice, and Sierra, members include bioethicist Jessica Flanigan and Montana oncologist James Burke.
Most eligible treatments will have completed Phase I, though Montana law also allows an alternative route based on equivalent documented safety evidence. Phase I work mainly tests safety and dosage, not efficacy.
How did Montana get beyond terminal-illness right-to-try?
Montana passed a traditional right-to-try statute in 2015 for products that finished Phase I and stayed in an FDA-approved trial. The federal Right to Try Act followed in 2018 for life-threatening conditions when approved options were exhausted and trial access was unavailable.
In 2023, lawmakers passed SB 422, sponsored by State Senator Ken Bogner and backed by the Alliance for Longevity Initiatives and other longevity advocates. Widely described as a U.S. first, it removed the terminal-illness restriction and required patients only to have "considered all" FDA-approved options.
SB 535, which passed narrowly in 2025, added infrastructure: experimental treatment centers that can charge for care and set payment arrangements involving digital or alternative currencies. Language was loosened further so patients need only have "evaluated other" approved options.
Why does the new review board matter for longevity access?
Infinita, founded by Niklas Anzinger and based in Próspera on Roatán, launched the initiative. Anzinger said patients need not have a defined disease state to qualify—important because aging is not classified as a disease.
Kaeberlein called Montana's model a middle ground with independent review, physician oversight, informed consent, and systematic data collection. Justice said experimental testing has often moved offshore and that Montana can bring it back with transparency; she will recuse herself from XPRIZE Healthspan-affiliated conflicts.
Board rigor and published safety data could ease bipartisan doubts about SB 535 and offer a template for other states—or eventually federal reform—while remaining distinct from FDA clearance.