Time For Independent US FDA? COVID Political Pressure Reignites Debate

The argument for an independent US Food and Drug Administration (FDA) has taken on renewed interest following President Trump’s political pressure on the agency to rapidly clear COVID-19 products, most notably a vaccine. But while the idea of a more independent agency enjoys broad stakeholder support, it is far from universal, and practical considerations suggest that the FDA will always face a fair degree of oversight by elected officials.

Still, it remains the hope of many – especially former commissioners who have sat in the political hotseat – that the FDA could obtain a greater degree of operational independence. In a January 2019 commentary in Health Affairs, seven former FDA heads – Robert Califf, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan, Andrew von Eschenbach and Frank Young – argued that the FDA should be moved out of the Department of Health and Human Services (HHS) and reconfigured as a separate federal agency