Montana’s Giving The Biotech Industry Sweeping Authority To Sell Unapproved Drugs

Investors on the libertarian fringe of the biotech industry are making their dream of widespread access to experimental drugs a reality in Montana.

Last year, they helped draft a state law to expand access to drugs that no regulator has deemed safe and effective. Now, Montana is relying on a privately run board to decide which treatments to offer — raising concerns about conflicts of interest and, in an industry rife with unfounded claims, whether patients will get value for their money.

A company that works with biotech firms in a regulation-free zone off the coast of Honduras is in charge. Last month, the board authorized its first treatment: Patients seeking a cure for hearing loss will take a daily antihistamine and listen to a Denver company’s proprietary sound mix for 60 minutes a day.

Startup biotech firms told POLITICO they hope Montana will serve as their shortcut around the Food and Drug Administration’s costly and extensive drug development process to the United States’ vast and lucrative drug market. They hope Montana’s new regime represents the beginning of a new “right-to-try” model that prioritizes patient access over paternalistic government oversight, while some patient advocates fear the state has put hucksters in charge of medical decisions.

The law’s sponsor, Republican state Sen. Kenneth Bogner, told POLITICO that Montana’s law will be a test case to “spur changes to the U.S. health care system that, in my opinion, isn't sustainable.” Bogner confirmed that he relied on biotech interests to draft the law.

The measure, SB 535, was born of patients’ frustration with federal law — including a 2018 right-to-try bill signed by President Donald Trump — that falls short of access for all. The federal law requires patients be terminally ill and to have exhausted all FDA-approved treatments and clinical trial options before seeking experimental treatment. Montana, by contrast, requires that patients give informed consent, have the money to pay and a provider’s recommendation. Bogner says he hopes the idea spreads to other states.

Investor Niklas Anzinger, who worked with the Alliance for Longevity Initiatives, a Virginia-based industry group, to draft the law, argues that small biotechs can’t compete in a market regulated through large, expensive clinical trials and that they need a system like Montana’s to finance and develop therapies that patients would otherwise never get. He says that Montana’s system will cut costs and provide a top-tier clinical space for Americans who now travel abroad for everything from psychedelic drugs in Mexico to cutting-edge hair replacement in Turkey and pricey stem cells in Switzerland.

“This is really kind of a potential paradigm change in how we do science instead of top down, more bottom up, but still in a controlled way with oversight and everything,” Anzinger said on a recent podcast.

Last year, he told Montana lawmakers that if they passed the law, their state “would no doubt have the potential to become the world's leader in accelerating patient access to innovative, potentially life-saving treatments.”

Industry advocates are now lobbying Trump and the FDA to steer clear because Montana’s success hinges on whether the agency takes enforcement actions against companies that participate. Those could include fines or stop work orders. The advocates fear the agency could also blackball companies in the federal drug approval process.

The alliance and Anzinger are nonetheless working to convince New Hampshire state lawmakers to enact a similar law.

The biotech industry has reason to hope it can count on allies in Washington. Health and Human Services Secretary Robert F. Kennedy Jr. has pledged to increase access to longevity treatments that purport to extend life, like stem cell therapies, peptides, and chelation. Last year, he said he had traveled to the Caribbean island of Antigua to receive an experimental stem-cell treatment for a neurological condition that affects his voice.

Anzinger, a 37-year-old German, is the founder of Infinita City, which helped create a hub for biotech companies in Próspera, an autonomous city in Honduras where drug companies can offer treatments without regulatory oversight. Anzinger’s venture-capital fund, Infinita VC, has invested in longevity startups there, including Minicircle, which sells a gene therapy intended to increase muscle mass, and Unlimited Bio, which is testing a gene therapy for circulation, endurance, and hair growth.

Próspera is part of a movement among bitcoin millionaires, startup founders, and libertarians to create autonomous private cities. Anzinger has promoted Montana in Próspera: In a co-working space for startups there earlier this year, tables and doors were decked with stickers that said: “SB535. Montana’s Longevity Law.”

Anzinger said Bogner invited him to Montana and “basically asked me, ‘Well, what else do we need to do? How does the law need to look like to bring you and the biotech companies that you're talking to?’"

The Montana law barely got through the state legislature last year amid intense opposition. It built on the state’s 2023 right-to-try legislation, which the Alliance for Longevity Initiatives also helped draft, setting parameters for licensed treatment centers where experimental therapies could be administered with the approval of privately run review boards. Montana allows people, regardless of condition, to access therapies that have passed small phase 1 clinical trials that establish that the product probably won’t kill patients, not that it works, making the state the most expansive in the country in its definition of right to try.

Anzinger has set up the only review board so far, operated by a private company owned by Infinita City. It charges a $12,500 application fee to companies interested in selling experimental treatments in the state.

Stephen Martin, who leads U.S. initiatives at Infinita and handles intake for the Montana review board, said the board provided the credentials of its board members to the state. Board members must disclose conflicts every time they review an application, he said. No conflicts have occurred yet, he added. Infinita cannot direct or overrule board decisions, according to the board’s rules.

He said other companies could set up review boards as well.

“If you think we are not doing a good job at oversight, come compete against us, do it better, and put us out of business,” he said.

The first to win the board’s approval is Parley Neurotech, a Denver biotech company that seeks to reverse hearing loss with a 30-day treatment of sound therapy, in combination with an off-label, FDA-approved antihistamine. Patients can’t yet be treated with the procedure because Montana hasn’t issued a license to an experimental treatment center. Two applications for a center are pending completion, the state health department said.

Sam Budoff, Parley’s CEO, said the law is the “right balance of regulation.” He said he feels confident that the phase 1 requirement and the review board structure would prevent any bad actors from participating in the program. He declined to share the cost of treatment but said it would reflect out-of-pocket prices for hearing aids, the price of which can vary from several hundred dollars to several thousand, depending on whether they are sold over-the-counter or are prescription aids fitted by an audiologist.

Under Montana’s rules, which took effect in July, any experimental review board with five members — including a Montana-licensed physician, a researcher with expertise in clinical outcome data, and an ethicist — can approve treatments. Unlike similarly structured boards used by pharmaceutical companies and academic medical centers to approve clinical trials, those in Montana are not supervised by the FDA.

“A for-profit IRB is in a context where there's multiple layers of oversight, this is not that,” said Ezekiel Emanuel, former chair of the department of bioethics at the National Institutes of Health. “What happens in experimental research? We learn something. What happens if you just willy-nilly try different people and then make some conclusion? Invariably, if it goes well, they're going to tout it. If it doesn't go well, they're going to bury it. And that's what bothers me.”

The chair of Infinita’s review board is longevity scientist Matt Kaeberlein. Kaeberlein also serves on the board of directors of the Alliance for Longevity Initiatives, the biotech industry group that helped draft Montana’s law. Kaeberlein said he planned to retire from the alliance soon, citing other commitments.

“The existing federal right-to-try, while on paper, can work, the reality is many companies are hesitant to use it, and so it's not happening,” Kaeberlein said. “Is this the perfect solution? Maybe. Probably not perfect. Is it a possible improvement? I think it is.”

Dylan Livingston, founder of the Alliance for Longevity Initiatives, said his group has no financial stake in any review board or treatment center. Alliance board members are unpaid, and their outside roles are independent of their work on the alliance, he said. The alliance hired a team of Montana lobbyists to push the law, and its lobbying spending included expenses at Helena restaurants and a country club with lawmakers, according to state records.

The industry’s role in administering the program has raised concerns about ethics and conflicts of interest.

"I know it's been described as right-to-try, I don't think it is,” said Arthur Caplan, former head of the division of medical ethics at New York University Grossman School of Medicine. “This thing they set up in Montana is really a program to facilitate access to anybody and everybody who wants it, to novel experimental interventions for anything.”

That, Caplan added, was a “risky endeavor.”

Some Montanans are unsettled, too. During a state legislative hearing last year, Erin Laws, a Montana resident and founder of the Montana Medical Freedom Alliance, a nonprofit that supports Kennedy’s Make America Healthy Again movement and its questioning of vaccine safety, said she worried there were “too many unknowns, and our laws are too vague for this bill. That is why these companies are salivating to come and operate here.”

Anzinger said that none of the companies in Infinita’s venture capital portfolio have submitted an application to the review board or have indicated plans to do so. The fund has no plans for further investments, he said.

Montana’s law requires some accountability. The board must make a public report of treatment approvals and safety outcomes at least once a year. The state’s health department oversees the licensing of experimental treatment centers and will confirm that each center contracts with a review board that complies with Montana’s rules, said Jon Ebelt, a state health department spokesperson, adding that its inspector general’s office has met with Infinita.

In interviews, some members of Infinita’s review board said they wanted to help bring rigor to a field plagued by risky, unproven longevity treatments. As injectable peptides have soared in popularity, for example, so have peptide injuries.

“The field of longevity is plagued right now by snake oil,” said review board member Felipe Sierra, a former director of the Division of Aging Biology at the National Institute on Aging, a federal agency. Trials in experimental treatment clinics could help generate data on the efficacy of antiaging therapies, he said. Those trials could be challenging to administer through the FDA’s normal clinical trial pipelines, since the agency considers aging a natural process, not a disease with defined clinical endpoints, like cancer or heart disease.  

Jamie Justice, who holds a PhD in neurophysiology and the physiology of aging and is executive director of a competition that awards money for longevity startups, said she joined the review board because she wanted to help Montana’s initiative succeed, and for there to be “some adults at the table” when ethically thorny questions arose.

“There are a million ways that this could fail and only a few that could go right,” Justice said.

Other board members are not as bullish on longevity treatments; they just want to open up access to investigational drugs, beyond one-off compassionate use cases. Bioethicist Jessica Flanigan, author of the book “Pharmaceutical Freedom,” said, “I view this as the next step in respecting people's medical autonomy and their rights to make major health decisions for themselves.”

Some biotech companies say they are wary of offering experimental treatments in Montana because doing so could spark an enforcement action by the FDA. In June, a group that included Infinita, patient advocates, and biotech companies met with FDA officials, including Deputy Commissioner Grace Graham, to ask for a guarantee that the agency wouldn’t take action against them in Montana. They said they have not received a direct answer.

An FDA spokesperson declined to comment.

To approve a treatment, the FDA typically requires three phases of clinical trials, including assessments of efficacy, dosage, and adverse events. Under its expanded access program, the FDA grants requests for unapproved treatments for patients with severe or life-threatening diseases. Such patients can also bypass the FDA and access unapproved treatments under the federal right-to-try law enacted in Trump’s first term, although few drugs have been used through the program, and critics have noted that companies don’t have an incentive to provide treatments outside of clinical trials. Companies aren’t allowed to make a profit under either program.

Biotech executives hoping to take advantage of Montana’s system have argued it could help them pursue FDA approval by enabling them to monetize their treatments and use the profit to fund clinical trials, which tend to cost hundreds of millions of dollars.

Stanley Kim of San Diego’s WinSanTor, which is developing a treatment for nerve damage known as peripheral neuropathy, submitted an application to Infinita’s review board. He hopes approval will let him sell the treatment and keep his company afloat.

“Montana law has been a God-send for us to try to get drugs to patients,” he said.

Earlier this month, Kim hired Robert Redfield, former director of the Centers for Disease Control and Prevention in the first Trump administration, as an adviser.

Redfield said in an interview that the Montana law “opens the door” for “smaller companies to get their product out there and evaluate whether it has efficacy or not.”

Without assurance that the FDA will allow companies to participate in Montana’s program, some patients say they still have to look abroad for experimental treatment.

“We don’t want to get anybody in trouble…But if the FDA won’t support us, what else can we do?” said Kris DeVault, a parent of a 3-year-old son diagnosed with an ultra-rare genetic disease that has no treatment. DeVault wants to go to Montana to receive an experimental treatment for his son, but the manufacturer is wary because of the possibility the FDA could shut it down.

He is now exploring going to Próspera.

This story was produced by The Axel Springer Global Reporters Network, a multi-publication initiative publishing scoops, investigations, interviews, op-eds, and analysis that reverberate across the world. It connects journalists from Axel Springer brands—including POLITICO, The Telegraph, Business Insider, WELT, BILD, and Onet— on major stories for an international audience. Their ambitious reporting stretches across Axel Springer platforms: online, print, TV, and audio. Together, the outlets reach hundreds of millions of people worldwide.