- Patrizia Cavazzoni will be the next director of the Food and Drug Administration's main drug review office, a top role she has held on an interim basis since her predecessor, Janet Woodcock, was tapped to assist the Trump administration's coronavirus drug program last year.
- Cavazzoni's appointment comes as the FDA's leadership could soon change. Woodcock is currently serving as acting FDA commissioner, and is believed to be among the top candidates for the job. But President Joe Biden has yet to make a nomination even as several other top roles within U.S. Department of Health and Human Services, which oversees the FDA, have been filled.
- Cavazzoni will be the fourth permanent director of the Center for Drug Evaluation and Research, or CDER, a role that has largely been defined by Woodcock since she first took the job in 1994. Cavazzoni joined the FDA in 2018 as CDER's deputy director for operations and became the acting principal deputy commissioner until that position was taken permanently by Amy Abernethy, who will step down from the agency this month.
Eleven weeks into his presidency, President Biden has yet to nominate an FDA commissioner.
The absence at the top has not prevented the agency from backfilling lower-ranking jobs, however. As a high-profile division, CDER, which regulates new drugs and medical products, is in need of a leader with the official weight of a permanent appointment. Monday's announcement gives that authority to Cavazzoni, a leader endorsed on Twitter by both Woodcock and former FDA Commissioner Scott Gottlieb.
The announcement also means Woodcock won't return to the top post at CDER, a job she has held for 24 of the past 27 years. In a memo to FDA staff, Woodcock noted that in addition to her current acting role as FDA commissioner, she also has a "position of record" as principal medical adviser to the next commissioner should someone else be chosen.
Woodcock's departure from her CDER post coincided with her assignment last year to Operation Warp Speed, the U.S. government initiative to fund the development of coronavirus vaccines and drugs. She left CDER to allay concerns about potential conflicts of interest between the roles, which involved both promoting and reviewing drugs for COVID-19.
She is now believed to be a leading candidate for the commissioner's job, along with former top FDA officials like Joshua Sharfstein, Luciana Borio and others. Abernethy was also believed to be in the running before she announced plans to leave the agency in April.
Whoever is the nominee, the next commissioner will face the task of boosting the morale of an agency targeted frequently by President Donald Trump and his administration. The FDA is also set to make an extremely consequential decision on an experimental Alzheimer's disease drug from Biogen by June, potentially setting up a daunting first test for any incoming agency head.
If Woodcock doesn't get nominated, Cavazzoni's elevation to CDER director could be "awkward" because of Woodcock's outsized role in developing the center, Cowen analyst Rick Weissenstein wrote in an April 12 note to clients.
Cavazzoni has a blend of academic, industry and government experience, however. She joined the FDA after 17 years working in various roles for Eli Lilly, Sanofi and Pfizer. Before that, she was an assistant professor at the University of Ottawa's medical school, where she treated and researched mood disorders.