The US Food and Drugs Administration (FDA) has confirmed that its director of the Centre for Drug Evaluation and Research (CDER), Patrizia Cavazzoni, has announced her resignation ahead of Donald Trump’s inauguration on 20 January.
An email was sent to employees announcing her resignation, which will see her leave on 18 January.
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In her email to colleagues, Cavazzoni reportedly wrote: “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 has worked at the FDA for seven years in roles such as deputy centre director for operations and acting director (in 2020).
Her departure is the latest in a series of FDA exits, including that of principal deputy commissioner Namandjé Bumpus, who left at the end of last year. Jeff Shuren departed as director of the medical devices unit in July, while deputy director for regulatory programs Douglas Throckmorton and FDA veteran Robert Temple recently retired.
Resignations have exacerbated questions about the future shape of the FDA under the incoming Trump administration. Current clues are limited, but President-elect Trump has nominated Dr Marty Makary as head.
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By GlobalDataMakary described the FDA as “broken” and “mired in politics and red tape,” in a Fox News article in 2021, but, coming from a medical background, Makary is one of Trump’s less surprising appointments. His likely priorities include faster drug review times, rolling trials, real-time evaluations and younger leadership of the FDA.
He sits against a backdrop of more controversial appointments, though. Eyebrows have been raised over the selection of both Robert F Kennedy Jr (RFK) as Secretary of the Department of Health and Human Services (HHS) and Dr Mehmet Oz as the administrator for the Centres for Medicare and Medicaid Services (CMS).
