Highlights

  • The bill, which people interested in extending human lifespan lobbied for, allows any drug produced in Montana to be administered so long as it has been through phase I clinical trials—trials that test for safety.
  • Once signed by Montana’s governor, the bill will be the most expansive in the country, allowing access to drugs for lifespan-extending purposes that have not received FDA approval.
  • Supporters of the bill hope it will enable people to try unproven longevity drugs and treatments without having to travel abroad and potentially make Montana a medical tourism hub.

A bill allowing medical clinics to peddle unproven therapies and drugs has been passed into law in the US state of Montana. Under this legislation, known as Montana Senate Bill 535, clinicians can apply for a license to open experimental treatment clinics as well as recommend and sell therapies not approved by the Food and Drug Administration (FDA). Once the state’s governor signs this bill, the law will become the most far-reaching in the nation, allowing access to therapies and drugs that have not been fully tested.

The bill will allow any drug produced in Montana to be sold within the state, provided that it has passed phase I clinical trials—the initial human trials that generally have a small number of participants, which are designed to test for safety. These trials, however, do not test whether drugs are effective.

More Details on Montana’s New Bill

Montana’s new bill, passed by the state legislature on April 29, 2025, is expected to be signed by Governor Greg Gianforte. It essentially serves as an expansion of the state’s existing Right to Try legislation. The Right to Try legislation was designed originally to allow those with terminal illnesses to access experimental treatments. The new bill expands on the Right to Try legislation, making it easier for clinics to apply for licensing for new, unproven drugs and treatments.

Interestingly, individuals and groups interested in extending human lifespans, from scientists to libertarians and influencers, drafted and lobbied for this new bill. Their overarching goal with crafting the bill was to make Montana a hotbed for people seeking experimental pro-longevity drugs and treatments.

“I see no reason why it couldn’t be adopted by most of the other states,” said Todd White, who helped develop the bill and who also directs an organization focused on aging research at a longevity conference in Washington, DC. He added that there are things that can be done at the federal level so that Right to Try laws similar to Montana’s new bill can more easily proliferate nationwide.

Controversy Surrounding the Bill

Bioethicists, professionals who examine the ethical, social, and legal issues arising from biomedical developments, have differing views on Montana’s new bill, though. Supporters say the bill gives individuals more autonomy to choose therapeutics for their bodies. For example, one bioethicist named Jessica Flanigan, who was at the same conference as Todd White in Washington, DC, said she is optimistic about this new legislation.

“It’s great any time anybody is trying to give people back their medical autonomy,” said Flanigan, according to a press release

Ultimately, Flanigan and other bioethicists in support of the bill hope that the new law will empower people to try new drugs and therapies that may extend their lives. In that sense, the bill could make it easier for Americans to try experimental treatments without having to travel abroad. As such, the new legislation could turn Montana into a hub for medical tourism.

On the other hand, some bioethicists and legal scholars are not quite so optimistic, and they are worried about the ethics surrounding the selling of unproven treatments. Additionally, they are concerned about the risks of something going wrong with the administration of these unproven treatments.

“I hate it,” said New York University’s Alison Bateman-House regarding the bill.

The Bill Will Allow Drugs and Therapies to Be Available Without Proven Efficacy

Federal laws in the US require that clinical trials show drugs are safe and effective before they receive approval to be sold. That requirement became law in the 1960s, following the thalidomide tragedy, where pregnant women took the drug thalidomide for morning sickness and some of them had babies with severe disabilities. Since that occurrence, the FDA has been responsible for approving drugs after clinical trials have demonstrated their safety and efficacy.

Along those lines, drugs typically go through a series of human trials. The initial human trials, phase I trials, generally utilize between 20 and 100 participants and test whether a drug is safe for humans. If a drug passes phase I trials, it moves on to trials with larger groups, often hundreds or even thousands of participants, testing for optimal doses and whether the drug works. After passing clinical trials, a drug can receive FDA approval; however, people prescribed it are monitored for side effects. Cumulatively, the clinical trial process is slow and can last longer than a decade, which can serve as a roadblock for people nearing the end of their lives who want to try an experimental drug.

Also, for many aging patients, getting access to unproven treatments may serve as their best chance of survival. For these people, that is what makes the risk of trying an unproven treatment worth the risk.

Expanding Right to Try Laws

Exceptions to the long, arduous clinical trial process have been made for people who are terminally ill under the Right to Try laws. These laws allow some terminally ill individuals to apply to receive experimental treatments that have already gone through phase I clinical trials but which have not received FDA approval.

Along these lines, Montana passed such a Right to Try measure in 2015, and a federal law was passed around three years later. Then, in 2023, Montana expanded its Right to Try law to include all patients living in Montana, not just people with terminal illnesses. This meant that anyone living in Montana could, theoretically, take a drug that had only passed phase I clinical trials.

Many longevity enthusiasts hailed Montana’s expansion of its Right to Try law, and some of them had helped in crafting the measure. However, that expansion of the law has not worked out as planned. For example, according to Todd White, there was no licensing, processing, or registration procedure for new clinics that might want to offer experimental drugs.

“There needed to be another bill that provided regulatory clarity for service providers,” said Todd White.

Montana’s New Legislation Could Turn the State Into a Medical Tourism Hub

The new bill in Montana addresses how longevity clinics selling experimental therapies can begin practicing in the state. Measures in the bill could turn Montana into a medical tourism hub, especially for those seeking access to experimental pro-longevity drugs and therapies.

As things are currently, plenty of Americans travel abroad to access experimental treatments that cannot be sold in the US legally, according to Dylan Livingston, founder and CEO of the Alliance for Longevity Initiatives, which hosts longevity-related events like the one in Washington, DC. Such experimental treatments include unproven stem cell and gene therapies.

“If you’re going to go and get an experimental gene therapy, you might as well keep it in the country,” said Livingston.

Livingston also suggested that other people might take an interest in trying a new drug designed to clear aged, dysfunctional cells (known as senescent cells) from tissues. This drug, currently entering phase II trials to treat an eye condition caused by diabetes, has passed phase I trials and demonstrated safety.

“One: let’s keep the money in the country, and two: if I was a millionaire getting an experimental gene therapy, I’d rather be in Montana than Honduras,” said Livingston.

Making Montana a New Hotbed for Experimental Treatments, Similar to the Island of Roatán, Honduras

Honduras serves as the current home base of sorts for experimental longevity therapies. The Honduran island of Roatán is the home of the Global Alliance for Regenerative Medicine clinic, which sells a controversial and unproven “anti-aging” gene therapy for around $20,000 to customers like the longevity influencer Bryan Johnson. The clinic also sells various unproven stem cell products.

(Bryan Johnson receives an unproven “anti-aging” gene therapy in Honduras. | technologyreview.com)


Venture capitalist and longevity connoisseur Niklas Anzinger also founded the city of Infinita in the economic zone of Próspera on the island of Roatán. Infinita is a private city where residents receive experimental treatments with lax medical regulations.

In building the city, Anzinger has aimed to build a “Los Alamos for longevity,” referencing the location where the US government developed its first nuclear weapon. In that sense, he wants Infinita to become a place where companies develop therapeutics that slow or even reverse human aging at warp speed and where people can make their own choices of whether to take experimental treatments.

Interestingly, Anzinger collaborated with Todd White, the longevity connoisseur who spoke at the longevity conference in Washington, DC., to craft Montana’s new bill.

“Right to Try has always been this thing [for people] who are terminal[ly ill] and trying a Hail Mary approach to solving these things; now Right to Try laws are being used to allow you to access treatments earlier,” said White to the audience at the longevity conference in DC. “Making it so that people can use longevity medicines earlier is, I think, a very important thing.”

Hence, Montana’s new bill provides the legal infrastructure for clinics that want to sell unproven treatments. The bill also states that clinics will need a license that must be renewed annually.

“Now somebody who actually wants to deliver drugs under the Right to Try law will be able to do so,” said White.

Trying to Ensure Safety

On top of that, the new bill requires that a person who takes an experimental drug provide written consent that includes a list of approved alternative drugs and a description of the worst possible outcome. This will help ensure that patients who receive unproven drugs or therapies understand the risks and alternatives associated with their treatments.

“In the Montana law, we explicitly enhanced the requirements for informed consent,” said Anzinger to the audience at the longevity conference in Washington, DC.

Anzinger hopes that the informed consent requirements, along with the treatments’ passage through phase I clinical trials, will ensure patients’ safety.

“We obviously don’t want to be killing people,” said Livingston.

Longevity Clinics Are Coming to Montana

With the passage of Montana’s new bill and its foundational legal framework for new longevity clinics, some companies are planning to set up shop in the state. According to Livingston, there are half a dozen companies interested in setting up longevity clinics in Montana. Out of the half a dozen, he says two or three are definitely going to set up clinics. Livingston would not name the companies that would set up longevity clinics but added that some of the interested clinicians already have US-based clinics, while others operate abroad. For example, Mac Davis, the founder and CEO of Minicircle, which developed the unproven “anti-aging” gene therapy, has said he is looking into opening a clinic in Montana.

“I think this can be an opportunity for America and Montana to really kind of corner the market when it comes to medical tourism,” said Livingston. “There is no other place in the world with this sort of regulatory environment.”