On Friday November 12, 2021, President Biden nominated former United States Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, a cardiologist by training, to again be FDA Commissioner, replacing acting Commissioner Dr. Janet Woodcock.
Califf, 70, was the FDA Commissioner for a year at the end of the Obama Administration. He garnered broad support his first time around and quickly won confirmation of the U.S. Senate in an 89-4 vote in February of 2016. Califf is a longtime Duke University researcher who has also worked for Verily and Google Health. He was previously Deputy Commissioner of FDA’s Office of Medical Products and Tobacco.
Califf will come to run the agency at a particularly challenging time, in the midst of continued COVID-19 pandemic, looming reauthorization of Prescription Drug User Fee Act (PDUFA), continued controversy surrounding FDA approval of an Alzheimer’s drug, tobacco product scrutiny, and opioid abuse. With Califf’s previous stint at FDA and his background in clinical trials and data-driven analysis, his nomination is widely seen as bringing steady and experienced leadership to the agency.
Once nominated by the President, Califf will face a confirmation hearing with the Senate Committee on Health, Education, Labor and Pensions (HELP) before seeking approval from the full Senate. Senate HELP is expected to schedule a confirmation hearing soon.
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