New Developments in Right to Try Legislation

• January 24, 2025

• Jack M. Ferdman
• David Peloquin , Ropes & Gray LLP
• Barbara E. Bierer , Multi-Regional Clinical Trials Center of Brigham & Women’s Hospital and Harvard

Almost exactly a decade after the first Right to Try laws (RTTs) were passed in state legislatures and over six years after the enactment of the federal Right to Try law, a new iteration of RTT is gaining momentum in state chambers. This legislation, known as the “Right to Try For Individualized Treatments” (RTT 2.0), is grounded in the same principles as the original law but focuses more narrowly on individualized therapies. While 41 states enacted RTT 1.0 prior to the passage of the federal Right To Try Act, it has rarely been utilized as an alternative pathway to access investigational products. Nevertheless, RTT 2.0 laws have been passed in six states and appear to be advancing in a number of additional states. This article discusses the federal RTT law in comparison to the U.S. Food and Drug Administration (FDA) expanded access pathway, compares RTT with RTT 2.0, and explores the challenges of each.

ARTICLE TAGS

• Academic Medical Centers and Teaching Hospitals Practice Group
• Physician Organizations Practice Group
• Life Sciences