Longevity field hails ‘landmark step’ as US state establishes framework for healthcare facilities to become experimental treatment centers.
The US state of Montana this week enacted a groundbreaking law that opens the door for clinics and physicians to provide experimental drugs and therapies that have not received approval from the US FDA. The new legislation, known as Senate Bill 535, was signed this week by Governor Greg Gianforte and builds upon the state’s recent expansion of so-called “Right to Try” laws.
Niklas Anzinger, the head of decentralized longevity initiative Infinita City, has long emphasized regulatory zones as a pathway to broader acceleration of therapies, and referred to the new law as a “groundbreaking moment.”
“The original SB 422, passed in October 2023, expanded Right to Try access to all patients – not just the terminally ill,” he told us. “That was the first step in enabling a preventative, longevity-focused model of healthcare, rather than reactive sick care. But a major gap remained: there was no clear regulatory pathway. Uncertainty around liability, payments, insurance, and the blurred lines between drug development and clinical care left the field in limbo. SB 535 changes that.”
The new bill establishes a formal licensing framework for healthcare facilities to become experimental treatment centers. These centers can recommend and administer nearly any experimental drug manufactured within Montana, provided it has passed Phase 1 trials.
A Phase 1 trial is the earliest stage of human testing and is typically focused primarily on demonstrating a drug’s safety rather than efficacy. By bypassing the more rigorous Phase 2 and 3 trials, Montana’s law dramatically accelerates the timeline by which patients can access new therapies compared to the traditional FDA approval process.
Adam Gries, co-founder and CEO of Vitalism Foundation told us: “It’s an important maturation of the Right-to-Try expansion that took effect last year, because it further defines rules by which providers and patients can benefit from accessing experimental treatments safely in the US, instead of going abroad for them.”
The law also requires clinics to allocate a portion of their profits to help low-income patients access these therapies and strengthens informed consent requirements-patients must receive a recommendation from their current physician and provide written consent that details alternative treatments and potential risks.
Landmark step for longevity
This is a potentially significant moment for longevity, with many in the field having called for regulation that empowers individuals to make informed decisions about their health. Hailing the new law, The Alliance for Longevity Initiatives (A4LI) issued a statement commending the politicians involved in the bill for “championing this transformative legislation.”
“The passage of SB 535 is a landmark step toward increasing innovation timelines and patient access to longevity medicine,” said A4LI founder and CEO Dylan Livingston. “Today, Montana has set a new standard for legislation that fuels forward-thinking biotech and therapeutic innovation.”
Anzinger concurs, telling us that the legislation “creates a dedicated framework” and enables the creation of centers “built specifically for delivering the most promising, regulated longevity therapies of the future.”
“It smooths the path for innovators while preserving patient safety, informed consent, and professional oversight,” he adds. “As an industry, we now have a responsibility. The current FDA approval process for longevity treatments is too slow and too expensive. It leaves millions of patients without access – or forces them to wait years for therapies already known to be safe elsewhere.”
‘Access can’t come at the cost of standards’
Of course, despite the enthusiasm from its supporters, the law has also sparked controversy, with opponents concerned that Phase 1 trials are not sufficient to ensure a drug’s safety, as they often involve too few participants to detect rare or long-term side effects, and that the vast majority of drugs entering clinical trials ultimately fail.
“Access can’t come at the cost of standards,” says Anzinger. “We need to show the world that longevity therapies can be delivered safely, ethically, and with measurable results. A lot of attention will be on the first movers. It’s up to us to prove this model works – by doing it right from the start.”
Now that clear rules are in place, Gries says that more visibility is now needed into which assets passed Phase 1 trials and which companies and organizations own them.
“Unfortunately, this information is still not easy to find,” he tells us. “As one of our projects at Vitalism Foundation we are working on finding and better surfacing this information for the public good. Secondly, most companies don’t know about this path. Through education and provision of easy, safe flows, we should encourage all companies and innovators who own such experimental treatments to explore the new path for them to provide their therapeutics in Montana.”
