By Vicki G. Norton, Ph.D., and Brandon A. Chan Ph.D.
The Federal Food, Drug and Cosmetic Act generally prohibits access to investigational drugs that have not yet been approved by the United States Food and Drug Administration. Patients that have been diagnosed with a life-threatening or seriously debilitating disease may request “expanded access” or compassionate use to gain access to investigational drugs pending FDA’s permission. Right-to-try laws seek to bypass the FDA’s more rigorous requirements for expanded access and permit terminally ill patients to access investigational drugs, biologics and devices that have completed Phase I but have yet to receive FDA approval. Today, most states have enacted some form of a right-to-try law, and a federal Right to Try Act was enacted in 2018. Recently, Montana has sought to further expand access to experimental treatments.