FDA quietly makes CDER director permanent

April 12, 2021

Patrizia Cavazzoni has been named the permanent director of the FDA’s Center for Drug Evaluation and Research.

Cavazzoni's appointment, which currently lacks a formal press release or announcement, was revealed today by Janet Woodcock via Twitter:
Pleased to announce the permanent appointment of Patrizia Cavazzoni, M.D., as @FDACDERDirector, a position she has been serving in for the past year and providing exceptional leadership during this critical and unprecedented time.

Dr. Cavazzoni, a board-certified psychiatrist, joined the FDA in January 2018 as CDER’s Deputy Director for Operations where she has led several key initiatives on behalf of the organization.

The appointment, however, raises questions about Janet Woodcock's future role at the FDA. Cavazzoni took over as acting director of CDER when Woodcock moved over to run the therapeutics side of Operation Warp Speed. Woodcock was then named Acting Commissioner of the FDA on January 20, 2021.

But now almost three months into the Biden administration, many are questioning why the agency does not have a Senate-approved leader. It has seemingly been a a two-person race between Woodcock and former principal deputy commissioner of FDA Josh Sharfstein, who’s now a vice dean and professor at Johns Hopkins. Six former FDA commissioners endorsed Woodcock, a 35-year FDA veteran, in a letter to the Biden administration last month, urging Biden to secure the agency’s leadership with a formal nomination.

Woodcock has served as director of CDER since 1994 but with Cavazzoni filling her role, the question is, where will Woodcock go if not nominated as permanent commissioner?