To meet its vast responsibilities for more than $2.5 trillion in products, the FDA should operate from a structure that best accommodates rigorous, science-based decisionmaking. This White Paper documents the growing demands on the agency and current barriers to regulatory efficiency, and provides supporting evidence for the Commissioners’ consensus recommendation on a two-step pathway to independence.

In June 2016, six former Commissioners of the Food and Drug Administration convened at Aspen Ideas: Health (previously Spotlight Health) to talk about the challenges facing the FDA. From that stage, they publicly announced their consensus view that the FDA should be transformed into an independent federal agency.