Candidates Emerge to Lead FDA

As the Biden Administration settles into Washington and works to address the COVID-19 pandemic, many medical products and food safety stakeholders wonder who will lead the Food and Drug Administration.  Janet Woodcock, M.D. who long led the Center for Drug Evaluation and Research (CDER) and advised “Operation Warp Speed” on COVID-19 therapeutics currently serves as Acting Commissioner of the agency.  On Sunday, February 7, more than 85 research, patient, and consumer groups ran a full-page advertisement in the Los Angeles Times, highlighting Dr. Woodcock’s work to modernize pharmaceutical manufacturing, advance medical research, issue guidance documents to describe regulatory standards, and provide information to consumers.  In January, several groups sent an open letter to the Department of Health and Human Services opposing Dr. Woodcock’s potential nomination because of her role in the opioid crisis.

On Friday, February 5, more than a dozen academics including former Centers for Medicare & Medicaid Services Administrator Donald Berwick sent an open letter to the Department of Health and Human Services expressing support for Joshua Sharfstein, MD.  Dr. Sharfstein is currently Vice Dean for Public Health Practice and Community Engagement at Johns Hopkins University’s Bloomberg School of Public Health and previously served as Secretary of the Maryland Department of Health and Mental Hygiene.  Notably, Sharfstein served as FDA’s Principal Deputy Commissioner for two years during the Obama Administration under Commissioner Peggy Hamburg, where he addressed a variety of issues including infant formula safety, the 510(k) approval process for medical devices, and tobacco use.

The Biden Administration has not announced a nominee for FDA Commissioner and the Senate Finance and Health, Education, Labor and Pensions Committees have not yet scheduled meetings to consider Xavier Becerra’s nomination to be Secretary of Health and Human Services.  In addition to overseeing FDA’s multi-faceted mission, the next Commissioner will work to evaluate COVID-19 vaccines, therapeutics, and diagnostics, as well as work with Congress to reauthorize the Prescription Drug User Fee Act.  The next commissioner will face a tough road ahead as the agency works to respond to the COVID-19 pandemic while performing its other critical responsibilities.

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