Montana's Senate Public Health, Welfare, and Safety Committee convened on March 28, 2025, to discuss Senate Bill 535, a proposed expansion of the state's "Right to Try" legislation aimed at enhancing patient access to experimental treatments. This bill builds on the previous Senate Bill 422, which established a framework for patients to access innovative therapies not yet approved by the FDA.
The primary focus of Senate Bill 535 is to streamline the process for healthcare providers and patients seeking experimental treatments. Proponents argue that the bill will clarify operational standards for experimental treatment centers, allowing for a more efficient licensing process and enhanced patient safety protocols. The bill proposes a $10,000 application fee and a $5,000 annual renewal fee for these centers, which will be overseen by the Department of Public Health and Human Services (DPHHS).
Key features of the bill include provisions for flexible payment models, the ability for out-of-state licensed physicians to work under Montana licensed medical directors, and an updated informed consent process that emphasizes patient understanding of the risks and benefits of experimental treatments. Supporters believe these changes will attract biotech companies to Montana, fostering innovation and economic growth in the state.
Several representatives from the longevity industry expressed their support during the meeting, highlighting the potential for Montana to become a hub for advanced healthcare solutions. They emphasized the importance of regulatory clarity in attracting investment and facilitating market entry for new treatments.
However, the bill faced opposition from the Montana Medical Association, which raised concerns about the lack of clarity regarding the bill's implications for existing medical research and patient safety. Critics worry that the bill could create bureaucratic hurdles for hospitals and undermine patient protections currently in place.
As the committee continues to deliberate on Senate Bill 535, the discussions reflect a broader conversation about balancing innovation in healthcare with the need for patient safety and regulatory oversight. The outcomes of this bill could significantly impact how Montanans access experimental treatments and the state's position in the biotech industry.