Montana opens a paid route to unapproved drugs for anyone who consents

State rules took effect July 25: a $12,500 review fee, a private board, and clinics that can sell experimental drugs at their own price.

Montana's operating rules for selling unapproved drugs took effect on July 25, and the state now has a working path from experimental compound to paying customer. A company whose drug has cleared preliminary testing — in some cases in as few as ten healthy people — can pay $12,500 to have its application reviewed by an approved board. If the board signs off, the company sets its own price and sells through experimental treatment clinics, the first of which is expected to open around the end of this year.

What separates Montana from other right-to-try jurisdictions is who qualifies. Elsewhere access is limited to people with terminal illness; here it is open in principle to anyone who gives informed consent and can pay, which includes people with rare diseases and people seeking drugs pitched as preventive or longevity therapies. Montana first passed a right-to-try law in 2015, expanded it to all patients in 2023, and passed the clinic statute in April 2025. The health department's rules were the last missing piece.

For patients who have run out of approved options, this converts a years-long wait into a price. That is also the trade. The state's first review board is a private entity, its members are paid a flat fee out of the same $12,500 application fees, and no FDA judgment stands behind what gets sold. Aaron Kesselheim, a Harvard Medical School professor who studies drug regulation, told MIT Technology Review he had concerns about selling unproven treatments without federal oversight.

That first board, announced this week, includes an oncologist, a bioethicist and three researchers from the longevity field. Watch whether rival boards form, and what the first approved drugs turn out to be.

Source: MIT Tech Review