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In recent years, several US states have accelerated the adoption and expansion of laws granting patients greater access to experimental medical treatments. Originally, Right to Try legislation was reserved for terminally or seriously ill patients who had exhausted all other therapeutic options, bypassing formal US Food and Drug Administration (FDA) approval in favor of increased patient autonomy. Montana has been at the forefront of this trend, passing new laws that enable individuals, including those who are not seriously ill, to access and purchase experimental, unproven drugs and procedures directly from clinics. The state´s latest legislative moves have sparked interest from advocacy groups and longevity enthusiasts, positioning Montana as a potential hub for those seeking innovative but largely untested medical solutions.
These legal reforms are part of a nationwide shift challenging the traditional, evidence-based framework of drug approval and regulatory oversight. Since the 1980s, patients too sick to participate in clinical trials have been able to apply for experimental treatments under FDA’s compassionate use program, which still subjects requests to some regulatory scrutiny. However, the model Right to Try law—initially championed by libertarian organizations like the Goldwater Institute and now adopted in some form by 41 states and federally since 2018—gives patients direct access to drugs with minimal regulatory interference. Recent laws in Georgia, Arizona, Mississippi, North Carolina, and Utah have moved further, permitting access to personalized and stem cell treatments, some of which lack any form of human clinical data or proven efficacy. Utah, for example, allows practitioners such as midwives and naturopaths to administer unproven placental stem cell therapies, underscoring the breadth of these changes.
While advocates argue that these laws empower patient choice and enhance medical autonomy, critics voice significant concerns. Medical ethicists, FDA law experts, and patient safety proponents point out the risks of widespread use of unproven treatments, highlighting financial incentives for prescribing physicians and the potential for legal protections to shield them from accountability if adverse effects occur. Concerns also persist about the weakening rigor of FDA drug approvals overall, with a trend toward fast-tracking drugs based on limited evidence. As various states experiment with looser regulations, stakeholders across the biomedical community are watching to see whether the trend brings real benefits—or exposes patients to greater harm—in an evolving landscape where the line between hope and hype grows increasingly blurred.
