Montana experimental drug access is moving from legislative theory to operating rules: the state’s Department of Health and Human Services has finalized requirements for clinics that want to sell treatments the US Food and Drug Administration has not approved.
Under Montana’s expanded right-to-try law, companies can apply to an experimental treatment review board after early testing of a drug. MIT Technology Review reported that the application fee is $12,500. If a board approves the application, the company may set its own price and offer the treatment through experimental treatment clinics.
The Montana model goes far beyond the usual right-to-try structure. Similar laws generally focus on patients with terminal illnesses. Montana’s law can apply to any adult who gives informed consent and can pay, including people seeking help for rare diseases and people interested in longevity or preventive therapies.
How does Montana’s experimental drug access work?
The state rules require informed consent and review by a board that includes a Montana-certified physician, scientists and an ethicist. A right-to-try law is a legal route for some patients to seek investigational drugs before full FDA approval, but Montana’s version broadens who may qualify and lets private clinics become the delivery channel.
The first review board, called the Montana ETRB, was announced by Infinita, a longevity-focused organization associated with tech entrepreneur Niklas Anzinger. After state senator Ken Bogner objected that the board’s website appeared to suggest official state status, the site was changed to say it is a private service run by Montana Governance Services Inc. Anzinger told MIT Technology Review that the company is registered in Montana and sits under the Infinita umbrella.
The board includes oncologist James Burke, bioethicist Jessica Flanigan, former aging official Felipe Sierra, gerontologist Jamie Justice and scientist Matt Kaeberlein. Infinita will pay board members from application fees, according to Anzinger, who says their decisions will be independent.
Supporters argue the arrangement adds structure to a gray market of unapproved interventions. Kaeberlein said the process would involve qualified medical professionals and oversight. Justice said she joined to help build a process with scientific rigor and accountability, especially for aging-related interventions.
Critics see a different risk: unapproved drugs sold to people outside the FDA’s normal guardrails. Aaron Kesselheim, a Harvard Medical School professor who studies drug regulation, told MIT Technology Review he would be concerned. He also warned against treating phase I testing as proof of safety, calling that assumption “very, very wrong.”
Which companies are applying?
Stephen Martin, Infinita’s US lead, said two applications have already reached the new board, from companies developing treatments for neuropathy and hearing loss. One came from WinSanTor, whose CEO Stanley Kim said the company is developing a phase II treatment for peripheral neuropathy and hears from patients desperate for access. Kim said WinSanTor still intends to continue regular clinical trials.
Other companies are wary. Thomas Joudinaud, CEO of Ceres Brain Therapeutics, said he has received a request from someone interested in using Montana’s system, but he is not applying now because a problem in Montana could hurt the company’s FDA standing.
The FDA has not given participants the comfort they want. Martin and others sought assurance that companies would not be penalized later, but the agency only restated federal right-to-try law. An FDA spokesperson said the agency does not comment on state legislation as a matter of policy.
Cost is another sharp difference. In FDA expanded-access programs, companies can generally charge only for costs tied to making, shipping and monitoring a drug, and must justify the price to the agency. Montana does not impose that limit. Kim said WinSanTor plans to sell at cost. Joudinaud suggested he would prefer a market price, and MIT Technology Review noted that recent median prices for new rare-disease drugs have reached $218,872.
The first Montana clinics are expected around the end of the year, according to MIT Technology Review. Treatment rooms, medical directors and review procedures are now the machinery that will determine how far this experiment goes.
This story draws on original reporting from MIT Technology Review.
