Reconciling States’ “Right to Try” Legislation and FDA’s Expanded Access Program

In the past few years, a number of states have passed “Right to Try” (RTT) laws. These laws aim to facilitate access by terminally ill patients to potentially lifesaving investigational products (most commonly drugs) that are not approved for the market but have passed phase I of the Food and Drug Administration’s (FDA’s) clinical trial process and continue to undergo testing in clinical trials. Two other conventional ways for patients to access potentially life-prolonging investigational drugs are through a clinical trial (if the patient meets enrollment criteria) or through the FDA’s expanded access program. This article discusses legal issues relating to the role of state and federal governments in expanded access to investigational drugs.