Montana right-to-try law clears path for experimental drug market

Montana right-to-try law expands access to experimental drugs

As of July 2026, biotech firms can pay $12,500 to submit a dossier to a state‑run review board and, after approval, sell unapproved medicines directly to consumers in Montana. The law, unique in allowing any informed adult to purchase a treatment—whether aimed at rare disease, oncology or longevity—creates the first U.S. “experimental drug hub.” Companies with data from as few as ten healthy volunteers can now set their own prices and operate through clinics expected to open by year‑end.

Regulatory framework and oversight

The Department of Health and Human Services issued rules mandating fully informed consent and a five‑member board comprising a Montana‑licensed physician, a bioethicist and three senior scientists. Matt Kaeberlein, a board member and former head of the Dog Aging Project, stresses that the process is “rigorous and transparent.”

“We aim to protect patients while fostering rapid innovation,”

he told Reuters.

Industry response

Early interest skews toward oncology and neuro‑degenerative therapies. WinSanTor’s CEO Stanley Kim has filed an application for a peripheral‑neuropathy drug still in Phase II, hoping to collect real‑world data while selling the product “at cost.” Conversely, French biotech Ceres Brain Therapeutics hesitates, fearing FDA retaliation; its chief executive Thomas Joudinaud notes that a misstep could jeopardize future approvals.

Pricing remains unrestricted. While some firms pledge cost‑plus pricing, others may target the ↓ $218,872 median price of rare‑disease therapies, raising ethical concerns echoed by Harvard’s Aaron Kesselheim.

Critics argue that bypassing federal oversight could expose patients to unknown risks. Yet supporters argue that the Montana model offers a “regulated marketplace” absent from the federal Right‑to‑Try Act, potentially accelerating data collection for life‑extension research.