Article by: Giorgia Giordani, Carla Pareja Paris, and Tom Zuber

Montana has enacted a groundbreaking law that significantly expands access to experimental medical treatments, positioning the state as a potential hub for innovation—and controversy—in the healthcare sector.

Senate Bill 535 (SB 535), signed into law by Governor Greg Gianforte in May 2025, authorizes the use of investigational drugs and therapies that have completed only Phase I clinical trials, bypassing traditional FDA approval pathways.

Key Provisions of the Law

SB 535 establishes a regulatory framework for the licensure of “Experimental Treatment Centers” in Montana. These centers, once licensed by the state’s Department of Public Health and Human Services, can recommend and administer experimental drugs, biologics, devices, and other therapies to patients who provide informed consent. The only requirement: the treatment must have passed Phase I clinical trials, which are designed to assess basic safety in a small group of participants.

Unlike the federal “Right to Try” Act of 2018, which was limited to terminally ill patients and still required some regulatory oversight, Montana’s law removes nearly all eligibility restrictions. Any adult patient in Montana, regardless of diagnosis, may seek access to these treatments.

The law also creates a pathway for clinics to operate legally, correcting a gap in previous state legislation that allowed access to experimental drugs but did not provide a mechanism for their administration.

Supporters’ Perspective

Proponents of SB 535—including longevity researchers, biotech entrepreneurs, and patient advocacy groups—argue that the law restores medical autonomy to patients and accelerates access to potentially life-saving or life-extending therapies. They envision Montana as a destination for medical tourism, where individuals can pursue cutting-edge treatments for conditions ranging from cancer to age-related decline, without the delays and restrictions of federal regulation.

Supporters also highlight the potential economic benefits, suggesting that the law could attract biotech startups, research investment, and high-profile clinics to the state. Some see Montana’s approach as a model for other states, potentially catalyzing a national shift toward more flexible, patient-driven access to experimental medicine.

Ethical and Legal Concerns

The law’s detractors—among them medical ethicists, legal scholars, and some healthcare professionals—warn that SB 535 exposes patients to significant risks. Phase I trials are designed only to identify immediate safety concerns, not to establish whether a treatment is effective or safe in the long term. With no requirement for FDA or institutional review board (IRB) oversight, critics fear that patients could be subjected to unproven, ineffective, or potentially harmful interventions.

There are also concerns about the potential for predatory practices, as clinics may market expensive, unproven therapies to desperate patients. The lack of robust data collection and scientific controls could undermine the integrity of medical research and complicate future efforts to evaluate the safety and efficacy of new treatments

The removal of FDA and IRB oversight also raises alarms about patient protections, data integrity, and long-term health outcomes. Critics caution that the legislation could open the door for predatory practices, especially in the absence of rigorous scientific controls.

There are also serious questions about the legality of Montana’s approach. While federal law still governs drug approval, Montana’s move may challenge the uniformity of health regulation across states and spur similar legislative efforts elsewhere. On the other hand, the Montana law may provoke a federal response, as the FDA is unlikely to cede authority over drug safety and approval. The Supremacy Clause of the U.S. Constitution gives federal regulations preemptive power, and courts may ultimately need to resolve the conflict. In the meantime, the uncertainty could create legal exposure for providers and confusion for patients about the status and legitimacy of the treatments offered.

Implications for Industry and Regulation

Montana’s legislation could attract biotech startups, alternative treatment providers, and international patients, effectively creating a deregulated zone for experimental medicine within the United States. This may accelerate innovation—but also legal battles and federal pushback.

The new law is also likely to affect how global pharmaceutical and biotechnology firms think about patient access programs and early-phase product rollouts. It raises important questions about the balance between innovation and safety, and about how federal and state jurisdictions intersect in the realm of medical treatment.

Conclusion

SB 535 marks a bold and contentious step in reimagining access to experimental medicine. As Montana opens its doors to experimental medicine, the state becomes a real-world laboratory for the future of healthcare access. The coming months and years will reveal whether this experiment leads to genuine breakthroughs for patients—or to new challenges in medical ethics, safety, and regulation.