President Joe Biden announced last week (November 12, 2021) that he plans to nominate Dr. Robert Califf as Commissioner of the US Food and Drug Administration (FDA). His nomination is subject to confirmation by the US Senate.

Dr. Califf previously served as FDA Commissioner from 2016-2017 and as Deputy Commissioner for Medical Products and Tobacco at FDA from 2015-2016.

He is currently a Professor of Medicine at the Duke University School of Medicine, where he previously served as Vice Chancellor and founded the Duke Clinical Research Institute. He also is a Senior Advisor for Google Health and Verily Life Sciences, the life science arm of Alphabet, the parent company of Google. He has nearly 40 years of experience as a doctor and researcher and is recognized for his expertise in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine.

As a result of Dr. Carliff’s nomination, Dr. Janet Woodcock stepped down as Acting Commissioner of the FDA. She was named Acting FDA Commissioner on January 20, 2021, and due to a statutory limit to how long a Senate-confirmed position can be filled by an Acting official, she either had to be named to the position on a permanent basis or step down by mid-November 2021. An appointed officer can only serve in an Acting capacity for 210 days plus an additional 90 days if the vacancy existed during a Presidential transition, which was the case, making mid-November the deadline to select a permanent FDA Commissioner. 

Dr. Woodcock has had a 35-year career with the FDA, where she most recently served as Director of the Center for Drug Evaluation and Research (CDER) and an advisor to Operation Warp Speed, the prior Administration’s initiative for developing COVID-19 vaccines, drugs, and testing.

In 1994, she was named Director of CDER, and in 2004, she became Deputy Commissioner and Chief Medical Officer in the Office of the Commissioner. Later she took on other executive leadership positions in the Commissioner’s Office, including Deputy Commissioner for Operations and Chief Operating Officer. In 2007, Dr. Woodcock returned as Director of CDER until she was asked to lend her expertise to Operation Warp Speed for developing therapeutics during the COVID-19 pandemic. From late 2020, she split her time advising Operation Warp Speed while also serving as the Principal Medical Advisor to the Commissioner on key priorities on behalf of the Office of the Commissioner.

Source: White House