Montana has become the first state to set up a licensing system that lets clinics offer experimental drugs, biologics, and devices to patients with a broad range of conditions, as long as those products have completed an early safety trial. The first treatment has already been authorized, and some biotech startups see the state as a possible shortcut around the FDA's lengthy approval process, Politico reported.
Under Senate Bill 535, signed by Gov. Greg Gianforte in May 2025, licensed experimental treatment centers may offer products that have completed Phase 1 testing but lack full FDA approval. The state's implementing rules were formally adopted this summer, Longevity. Technology reported. Unlike the federal right-to-try law, Montana's framework does not limit access to people with terminal illness.
For patients and families, the key question is simple. Passing Phase 1 shows that a product was tolerated by a small group of people for a short time. It does not show that the product works.
A Phase 1 Pass Is Not Proof a Treatment Works
Phase 1 studies typically involve 20 to 100 healthy volunteers or people with the targeted condition and last several months, according to the FDA. Their main purpose is to study safety and dosing.
About 70% of drugs move from Phase 1 to Phase 2, the FDA says. Larger Phase 2 and Phase 3 trials, which can involve hundreds to thousands of people over several years, are where effectiveness is tested and less common side effects are more likely to appear. Many drugs that enter human testing never win approval, often because later trials show they do not work well enough or cause unexpected harm.
Long-term effects, interactions with other medicines, and risks for people with multiple health conditions may be largely unknown after Phase 1.
The first treatment authorized under Montana's system targets neurological hearing loss. According to Politico, patients will take a daily antihistamine and listen to a Denver company's proprietary sound mix for 60 minutes a day. The developer, Parley Neurotech, declined to share the treatment's cost but said Montana sales would help fund future clinical trials.
What Montana's Rules Require
The rules, as proposed in draft form and summarized by the law firm Duane Morris, require each center to sign a written agreement with each patient that lists the treatment, its clinical trial phase, all anticipated costs, and an acknowledgment about health insurance.
Patient files must document that a treating practitioner recommended experimental access and that the patient evaluated and attempted other FDA-approved treatment options. Centers must report adverse events to the state within five days. Events are considered serious if they result in death, a life-threatening event, hospitalization, lasting disability, or a birth defect.
Each center must use an experimental treatment review board with at least four members, including a Montana-licensed physician, a researcher with expertise in clinical outcome data, and an ethicist. Board members may not have financial or other ties to the centers they review, and boards must publish at least an annual safety summary.
Questions About Who Oversees the Board
Critics have focused on who runs the first review board. The five-member board was set up by biotech investor Niklas Anzinger and is operated by a private company owned by Infinita City, according to Politico. Anzinger founded Infinita City, which helped create a biotech hub in Próspera, an autonomous city in Honduras where companies can offer treatments without regulatory oversight. The board charges companies a $12,500 application fee.
The law's sponsor, Republican state Sen. Kenneth Bogner, told Politico he relied on biotech interests to draft the law and hopes it will "spur changes to the U.S. health care system that, in my opinion, isn't sustainable."
Medical ethicists, legal scholars, and some health care professionals have warned that the law could expose patients to unproven or harmful treatments and to expensive marketing aimed at people with few options. Supporters argue the model gives patients faster access and more control over their care.
Approval by a state review board is not FDA approval, and it gives a treatment no federal legal status. Whether federal regulators will challenge Montana's framework remains unclear.
Costs, Insurance, and Legal Rights for Patients
Treatment prices are set by the companies, and insurance is unlikely to pay for products that lack FDA approval. Patient agreements must include the text of a Montana law on immunity from lawsuits, which may limit legal options if something goes wrong.
The people most exposed to risk include those with serious illnesses who have run out of options, older adults taking multiple medicines, and people drawn by longevity or anti-aging marketing. Visitors from other states should also consider how follow-up care will work once they return home and who will pay for emergency treatment if a complication appears later.
Anyone considering an experimental treatment can ask what trial data exist, how many people have received it, what side effects were seen, what the full cost will be, and who will manage complications. Sharing those details with a regular doctor before starting is a reasonable step.
New or worsening symptoms after an experimental treatment, including rash, swelling, trouble breathing, chest pain, or confusion, require prompt medical care. People who experience problems can also report them to FDA MedWatch.
Montana's experiment offers new access, but the evidence behind each treatment will vary widely, and patients will carry much of the burden of sorting that out.
Key Questions Answered
What does Montana's law allow? Licensed experimental treatment centers may provide drugs, biologics, and devices that have completed Phase 1 trials but lack full FDA approval to patients with a broad range of conditions.
What does a Phase 1 trial show? It mainly studies safety and dosing in a small group, often 20 to 100 people. It does not establish whether a treatment works.
Has any treatment been authorized? Yes. The first review board authorized a hearing loss treatment that combines an antihistamine with a sound therapy program.
Will insurance cover these treatments? Coverage is unlikely because the products are not FDA-approved. Patients should get full cost details in writing.
What protections do patients have? Written agreements, informed consent, adverse event reporting, and review board oversight, though patients may have limited legal recourse.
