Speakers:
Jon Bigelow
Robert Matheis

After several year of innovation and growing efficiency under Commissioners Hamburg, Califf, and Gottlieb, since COVID-19 appeared the FDA has undergone unprecedented political attacks for alleged delays, red tape, and even "deep state" behaviour; it has been embarrassed by early delays in approving COVID tests; then by issuing an emergency use authorization for hydroxychloroquine in COVID despite absence of evidence (since withdrawn), and other errors; and any vaccine approval now faces facets of the American public that is suspicious of the entire process. Under President Biden, there will be a new Commissioner and effort to rebuild the FDA's credibility. Taking into account the trajectory of the pandemic, this session will cover the outlook for the FDA, its new leadership, its credibility with the public, and how the FDA's role has changed as well as implications for clinical trials, drug approvals and promotional regulation.

Learning objectives:

• Examine implications of the loss of the FDA's credibility with patients, HCPs, industry and Congress
• Understand the priorities of the FDA's new leadership and political limitations they work under
• Consider lessons learned during the pandemic and how those may affect future FDA activities procedures