Montana lets biotech charge $12,500 for “right to try” review with as few as 10 people

Montana’s “right to try” rollout is moving from debate to operations, and the application fee is not small: as of this week, biotech companies can pay $12,500 to apply to a newly established review board for approval of experimental drugs. The catch, and the part that will make compliance teams and ethicists sit up, is that these drugs may have been through preliminary testing sometimes in as few as 10 healthy people.

Once a drug gets the board’s rubber stamp, the company can sell it via experimental treatment clinics, with the first clinics likely to be up and running around the end of this year. The law is built around access and consent, but it collides with a more traditional idea in medicine: if you do not have enough evidence, you do not get mass exposure.

Montana’s approach is designed to be simple on paper. Access to experimental drugs is theoretically available to anyone who gives informed consent and can pay. That means the pathway is less about doctors prescribing an approved treatment and more about patients navigating a clinic setting for a therapy that is still early. For some people, especially those in the longevity community, that can sound like a breakthrough, a hopeful answer to a long-running complaint: promising treatments get stuck behind regulatory timelines that can feel out of reach.

But the same simplicity is also the core of the criticism. The source flags that others see the system as unethical and dangerous, precisely because consent and ability to pay do not substitute for the uncertainty of preliminary testing. In other words, the board may act like a gate, but the evidence base feeding that gate is thin by design in some cases. And when drugs are sold through clinics, the incentives in the ecosystem start to look different than in a standard clinical trial setting.

That tension is not theoretical. The source includes the story of Kris DeVault, who is desperate to access an experimental drug being developed for his son Brody’s condition, creatine transporter deficiency, a rare disorder in which the brain and muscles lack the energy they need to develop. There are no cures for Brody’s condition. DeVault learned of a company developing a drug that might help, but the drug is still early, tested in animals and a small number of healthy adults, and doctors cannot prescribe it. DeVault’s situation captures the human stakes that often drive right-to-try legislation in the first place: patients who are running out of time see a pathway to try something before the system finishes its full, evidence-heavy process.

The policy question is what happens when “try” becomes a commercial product rather than a tightly controlled clinical trial option. Montana’s plan explicitly ties board approval to sales through experimental treatment clinics. The first of those clinics is expected to be up and running around the end of this year, which is fast enough that the second-order effects will arrive before many stakeholders are ready. For biotech companies, a fee-based review and a route to clinic sales could change internal development and commercial strategies, especially for programs sitting early after preliminary testing.

For regulators and policymakers elsewhere, Montana also becomes a live benchmark. If a state can operationalize access quickly, other jurisdictions will feel pressure to either follow, compete, or counterbalance. Investors will also notice, because any new pathway that shortens the time from early testing to paid patient access alters risk models and potential revenue timing, even if it also invites reputational and legal scrutiny.

And for health systems, pharmacies, and clinical operators, the headline issue is practical: how do you handle informed consent, patient selection, and safety monitoring when the evidence is early, the patient population may be broad, and the treatment is delivered through clinics? The source frames the law as unique because access is theoretically available to anyone who gives informed consent and can pay. That raises hard questions about what “informed” means when the underlying data is limited, and what happens if outcomes are unclear or adverse.

Zoom out and Montana’s move starts to rhyme with a broader theme in this same newsletter: Congress used to evaluate emerging technologies through the US Office of Technology Assessment, which produced some 750 reports during its 23-year history, assessing technologies like electronic surveillance, genetic engineering, and remote sensing from outer space. It was defunded in 1995, and there are recurring calls to bring it back, especially as robotics, big data, and AI systems have made scrutiny feel more urgent. Montana’s “right to try” experiment sits in the same neighborhood of questions: when new capabilities arrive faster than institutions can evaluate them, who does the evaluation, how rigorous is it, and who bears the consequences?