Montana's Right-to-Try Experiment

A new state law lets biotech companies sell drugs that have cleared only the smallest, earliest phase of testing — no FDA approval required. Supporters call it a lifeline for patients out of options. Critics call it a $12,500-application-fee shortcut around the system that keeps medicine safe.

For most drugs sold in the United States, getting to a pharmacy shelf means clearing three phases of clinical trials over several years, then winning sign-off from the Food and Drug Administration. Montana just built a second road. Under a law that took effect this year, biotech companies can apply to sell experimental drugs, stem cell procedures, and antiaging therapies directly to patients after finishing only the first and smallest phase of testing — the phase designed to check whether a treatment is safe enough not to kill the handful of people who first try it, not whether it actually works.

The state finalized the regulatory rules on July 25, 2026, clearing the way for licensed "experimental treatment clinics" to open before the end of the year. Two companies — developing treatments for neuropathy and hearing loss — have already applied.

How the program works

A company that wants to sell an unapproved drug in Montana applies to the state's Experimental Therapeutics Review Board, known as METRB, an independent panel that includes longevity researchers and at least one Montana-licensed physician. If approved, the company can open or partner with a licensed clinic, and — unlike the FDA's existing "compassionate use" expanded-access program, which limits companies to recovering their manufacturing cost — it can set the drug's price at whatever the market will bear.

The program by the numbers:

$12,500 — the application fee a company pays METRB to seek approval to sell an unapproved treatment
Phase 1 — the only trial stage required, sometimes tested on as few as ten people
No cap — on pricing; companies set their own rate, unlike FDA expanded access

Clinics that administer these treatments must report side effects to state authorities, keep an independent review board of their own, and operate under a licensed medical director. Supporters, including state Sen. Ken Bogner, who sponsored the 2023 law this program expands on, frame it as restoring a patient's right to try a promising treatment rather than wait years for Washington. Backers like tech entrepreneur Niklas Anzinger, a longevity-industry figure who has pushed to make Montana a hub for experimental medicine, see it as a way to get treatments to willing patients faster than the FDA's traditional timeline allows.

What Phase 1 actually tells you

Reading the fine print: A Phase 1 trial answers one narrow question: did this drug seriously harm the small group of people, sometimes as few as ten, who took it first? It is not designed to show whether the drug works, and it typically isn't tested against a placebo.

Historically, only 15–30% of drugs that enter clinical trials at all ever go on to win FDA approval, and only around 30% of drugs that clear Phase 1 make it as far as Phase 3, the stage that tests real-world effectiveness at scale. (Figures as reported by physician-researchers writing in Science-Based Medicine, citing industry trial-success data.)

That's the core of the safety debate. Because Montana's law drops the federal Right to Try Act's requirement that a patient be terminally ill, and doesn't require a treatment to show any evidence it works, critics argue it opens a lane for expensive, unproven interventions — everything from legitimate late-stage biotech candidates to what one longtime medical researcher has compared to "Hallwang-style" clinics abroad that mix real medicine with unproven add-ons. The law also allows outside groups to stand up competing review boards with as few as four members, including only one Montana-licensed physician, which critics say could let clinics with weaker standards shop for the friendliest approval body.

An unsettled question with the FDA

Montana's law raises a legal question nobody has fully answered yet: federal law generally restricts shipping unapproved drugs across state lines, and the FDA has never said whether it will challenge clinics operating under Montana's framework or simply decline to enforce against them. That uncertainty is itself shaping the market — some manufacturers are reportedly hesitant to participate in Montana's program at all until they know how the FDA, and potentially Congress, will respond.

What it means for patients

For a patient with a rare or hard-to-treat condition who has exhausted approved options, Montana's clinics may offer a real, if unproven, option that federal expanded-access rules make difficult to reach — and one they'll likely pay full market price for out of pocket, since insurance typically won't cover treatment that lacks FDA approval. For everyone else, the law is worth watching less as a Montana story than as a preview of a fight over how much evidence a treatment should need before it's allowed to be sold — a debate that is likely to reach far beyond Montana's borders if the state's clinics open as planned before the end of 2026.

This article is for general information and does not constitute medical advice. Anyone considering treatment through a right-to-try program should discuss the risks and their own medical history with a qualified physician first.