Vicki Norton is a partner at the Duane Morris law firm, where she co-leads the life sciences team.
My 84-year-old mother succumbed to pancreatic cancer while exploring experimental therapies after standard care failed. State and federal right-to-try laws allow patients like my mom to seek more-promising early-stage treatments. But these laws do not provide enough infrastructure to help patients wade through options and red tape.
Legislative reform, however, is gaining momentum in one unlikely place: Montana.
By enacting S.B. 535 in 2025, Montana became the first state to establish a licensing framework for experimental treatment centers where patients can seek help in accessing therapies that have completed Phase 1 clinical trials but are still under evaluation for safety and efficacy by the Food and Drug Administration.
In 2023, Montana extended its right-to-try law beyond interventions for serious and life-threatening conditions. But the 2025 law goes further. It introduces a category of licensed health care facilities authorized to recommend and administer investigational treatments. Montana created not just a legal right for patients to seek early-stage options but an infrastructure to deliver them.
The practical effect is significant. Montana is now positioned as a destination for medical tourists seeking antiaging drugs, stem cell procedures and other therapies that have cleared initial safety trials but remain years away from FDA approval.
Initial concerns that S.B. 535 was too skewed toward patient rights at the expense of patient safety have been partly allayed by regulations implementing safeguards, which were notably absent from the statute itself. For example, the regulations adopted by the Montana Department of Public Health and Human Services in July require reporting side effects, forming independent boards to approve clinical decisions, and developing programs to ensure quality by reviewing, for example, patient grievances and outcomes. In addition, centers must meet staffing and governance requirements, including retaining a medical director with a Montana license in good standing, who will develop and maintain a system for tracking patient outcomes and treatment approval status.
But additional questions remain.
The right-to-try movement began at the state level in 2014 to promote patient rights. Within four years, 40 states had enacted some form of right-to-try legislation, creating momentum that Congress could not ignore. By May 2018, a federal right-to-try bill was signed into law. The state laws normalized right-to-try, created a political constituency of patients and advocacy groups, and generated pressure for a uniform federal framework that reduced uncertainty for manufacturers operating across state lines.
Could Montana trigger a similar groundswell? There are reasons to think that these new facilities may not gain the same traction. Original right-to-try laws were narrowly targeted at seriously ill patients seeking last-resort access to drugs still being tested — a politically sympathetic population with a straightforward narrative. Montana’s law is far more expansive, establishing a system for delivering experimental treatments to patients with any condition at negotiated prices.
Further, part of the rationale for S.B. 535 was to address the geographic gap in access felt acutely in Montana and other rural states underrepresented in clinical trials. To ensure that the treatment centers do not just become destinations for wealthy out-of-state tourists while leaving Montanans behind, S.B. 535 requires these new centers to allocate 2 percent of net profits to support access to care for qualifying Montana residents.
The law’s expansive scope, set against a policy objective rooted largely in Montana’s access-to-care challenges, may limit its appeal to other states and draw criticism from regulators and patient advocates who view the legislation as insufficiently protective of patient safety, notwithstanding the regulations.
A more pressing concern is whether federal action is needed to address legal exposure for manufacturers or clinics shipping unapproved treatments to Montana. The federal Food, Drug, and Cosmetic Act generally prohibits introducing unapproved drugs into interstate commerce.
The federal right-to-try act carved out an exemption for eligible novel drugs provided to patients with serious or life-threatening ailments, but S.B. 535 allows for the sale of experimental treatments at licensed facilities to a broad patient population.
Two questions remain: whether the federal right-to-try exemption covers this new model — at least for dire health issues — and whether the FDA will decline to exercise its enforcement discretion against manufacturers shipping products to Montana.
If the state succeeds and others follow, the resulting patchwork of licensing regimes may generate demand for federal clarification through congressional legislation or FDA guidance. But manufacturers, investors and providers considering early entry into Montana’s experimental treatment-center market cannot afford to wait. They need clarity on federal legal exposure today.
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