Montana Finalizes Rules for Direct Sale of Experimental Drugs to General Public
New regulations allow biotech firms to bypass traditional FDA pathways and sell unproven treatments through specialized clinics.
Montana has finalized regulations that allow biotechnology companies to sell experimental drugs directly to consumers, regardless of whether the patient is terminally ill. The move establishes a state-level framework that significantly diverges from federal drug-approval standards.
Under the new rules, biotech companies can apply for approval from a newly created state review board after completing preliminary Phase I testing. This initial testing phase may involve as few as 10 healthy volunteers. To seek approval, companies must pay a $12,500 application fee to the Experimental Treatment Review Board. Once the board grants approval, companies are permitted to set their own prices for the treatments. These drugs will be distributed through specialized clinics, which are expected to begin operations by the end of 2026.
A Shift Toward Longevity Hubs
This regulatory shift is the culmination of a decade-long expansion of patient access in the state. Montana originally enacted a "right to try" law in 2015, which was strictly limited to terminally ill patients. In 2023, the state expanded this access to include patients who are not terminally ill. This was followed by a 2025 law, SB535, which established the operational rules for the clinics. The current regulations finalize the state's operating structure, moving Montana toward becoming a hub for experimental treatments, a transition heavily influenced by longevity enthusiasts.
Bypassing the FDA
By allowing direct sales to the general public after minimal testing, Montana has created the broadest state-level alternative to the U.S. Food and Drug Administration (FDA) approval process in the country. State Sen. Ken Bogner stated that the policy was intended to encourage preventive medicine as well as provide additional options for people already confronting disease.
However, the framework raises significant concerns regarding patient safety and the potential for companies to profit from unproven treatments by bypassing traditional, rigorous clinical trials. Supporters of the measure argue that the acceleration of access is necessary for those seeking life-extending and preventive therapies that would otherwise take years to clear federal hurdles.
Oversight and Implementation
As the state prepares for the 2026 clinic openings, the focus shifts to the Experimental Treatment Review Board. According to reports, board members will be compensated by Infinita, a company owned by Niklas Anzinger, using the $12,500 application fees collected from the biotech firms seeking approval. Observers will be watching how the board evaluates the safety of Phase I data and whether the resulting clinics maintain medical standards as they open their doors to the non-terminally ill public.