Patrizia Cavazzoni, leader of the Food and Drug Administration’s Center for Drug Evaluation and Research, is leaving the agency on Jan. 18, the latest top official to exit as Donald Trump prepares to take office.
The director shared the news with staff on Friday morning, according to an email reviewed by STAT. Jacqueline Corrigan-Curay, CDER’s principal deputy center director, will take Cavazzoni’s place pending ethics clearance, FDA Commissioner Robert Califf said in an email reviewed by STAT.
“Leaving CDER was an extremely difficult decision, but the time has come for me to be more present for my family, who have taken the backseat over the past few years due to the demands of my role and our critically important public health work,” Cavazzoni wrote in her email.
CDER is arguably the most important division in the FDA, charged with reviewing nearly all drug approvals, handling drug shortages, and investigating facilities worldwide for safety issues.
Public health experts have expressed concern that longtime FDA staff may choose to leave due to fears of working in an antagonistic environment, depleting the agency of expertise.
Robert F. Kennedy Jr., Donald Trump’s pick for secretary of Health and Human Services, was hostile to FDA career civil servants during the campaign, saying that if they are part of a “corrupt system,” they should “pack their bags.” But Marty Makary, Trump’s pick for FDA commissioner, is less controversial than Kennedy and may be able to win over career staff considering departures.
FDA Deputy Commissioner Namandjé Bumpus announced plans to leave in December. Other staff, like the molecular and developmental immunology chief and the senior advisor for clinical science, retired from the agency in December.
In a note to staff, Califf thanked Cavazzoni for her service and praised her work to streamline the drug approval workflow and to counter misinformation.
“When I returned to the FDA in 2022, I was amazed by her dual effort of taking on the pandemic and CDER’s huge regulatory and public health portfolio at the same time,” Califf wrote.
Longtime top drug regulator Janet Woodcock recruited Cavazzoni as deputy director of operations for CDER in 2018, positioning her as a potential successor.
Cavazzoni ultimately stepped into the role in 2020 after Woodcock took a leave of absence to focus on the coronavirus response. She was named permanent leader of the agency’s largest center in 2021 as Woodcock became interim FDA commissioner. Woodcock, unable to secure the lawmaker votes necessary to become permanent commissioner, became principal deputy commissioner in 2022 instead. She announced her retirement in November 2023 after 34 years at the FDA.
Colleagues told STAT at the time that Cavazzoni was known as a problem-solver willing to take on some of the agency’s thorniest problems. Others criticized her ties to industry and her history of defending drugs with safety problems. She spent eight years at Pfizer, playing a key role defending the company against legal claims that it downplayed risks that the antipsychotic drug Zyprexa could lead to type 2 diabetes.
Under her tenure, Cavazzoni had to answer for the agency’s controversial approval of Biogen’s drug Aduhelm to treat Alzheimer’s, despite an overwhelming negative vote by its scientific advisers.