Enacted precedent
Montana SB 535 creates a licensed, supervised path for eligible patients to consider experimental treatment after reviewing approved choices with a treating clinician.
Read enrolled SB 535How Montana is accelerating clinical discovery
Montana removed the terminal-illness restriction in 2023. In 2025, SB 535 created licensed experimental treatment centers, direct provider-patient payment agreements, outcome monitoring, adverse event reporting, and an access requirement funded by 2% of each center's net annual profits.
2015
Montana creates an initial access path for eligible patients.
2023
The state removes the terminal-illness restriction from its Right to Try law.
2025
The law defines experimental treatments and establishes state licensing, safety, consent, and oversight requirements.
2026
Final rules take effect and Montana publishes the experimental treatment center application.
Read the official enrolled SB 535 , final rules , and licensing page .
Experimental treatment centers must obtain a state license and operate within Montana's facility rules.
A treating health care provider identifies the patient as eligible after considering approved options.
The patient receives the treatment's possible outcomes, approved alternatives, insurance limits, and costs.
Centers must meet professional, safety, recordkeeping, inspection, and reporting requirements.
Licensing boards retain authority over professional conduct and care provided under the law.
The statute covers drugs, biologics, devices, procedures, and individualized treatments that meet its conditions.
The operating rules for experimental treatment centers took effect July 25, 2026, with an independent expert review board evaluating treatments.
A company with a drug through preliminary safety testing pays $12,500 to ask the review board for approval to offer it in Montana.
Treatments for neuropathy and hearing loss are already under review. The first licensed clinics are expected around the end of 2026.
Reported by MIT Technology Review (July 30, 2026) · Board details at montanaetrb.org
SB 535 establishes access, licensing, consent, and oversight. The Institute's decentralized FDA proposal would add standardized outcome measures and pooled public evidence across participating patients and centers.
See the evidence modelQuestion 1 of 3
Pragmatic trials compare treatments during routine care. Participation remains voluntary and requires informed consent and appropriate safety oversight.