In June 2016, six former Commissioners of the US Food and Drug Administration convened at Aspen Ideas: Health (previously Spotlight Health) in Aspen, Colorado, to talk about the challenges facing the FDA, which regulates roughly 20 cents of every dollar spent by American consumers each year. On that occasion, they publicly announced their agreement that the FDA should be transformed into an independent federal agency.
This paper advances that idea, explains the rationale for it, and suggests a path forward. It is built on an 18-month series of discussions with the Commissioners (including a seventh, who joined the group in 2017), and presents evidence to support their shared view that independence, free from administrative bottlenecks, will put the FDA in the strongest possible position to meet the challenges of the 21st century, as science rapidly evolves, products become increasingly complex, and the economy grows ever more globalized.
