Montana Finalizes Rules for Non-FDA Approved Drug Sales

Montana has finalized administrative rules enabling the commercial distribution of experimental drugs that have not received U.S. Food and Drug Administration (FDA) approval. Biotech firms may now submit applications to private review boards for authorization to sell unproven treatments directly to consumers. The state’s regulatory framework permits access for any individual providing informed consent, extending beyond the terminal illness criteria typically found in similar "right-to-try" legislation.

Operational oversight is delegated to private review boards, such as the newly established Montana Experimental Treatment Review Board. These entities are responsible for evaluating clinical data and ensuring ethical standards, funded by a $12,500 application fee per drug. The first clinics offering these treatments are expected to commence operations by the end of 2025.

This policy shift presents significant regulatory and liability risks, as it bypasses federal safety and efficacy standards. Critics highlight the potential for patient harm and the lack of institutional accountability, noting that the review boards operate as private entities rather than state-sanctioned bodies. The initiative is primarily driven by private longevity-focused organizations rather than traditional medical or patient advocacy groups.