Sara Brenner, FDA device official, named agency’s acting head

Sara Brenner, a Food and Drug Administration official within the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made to a webpage listing leadership biographies.

The FDA declined to comment, citing a communications pause imposed by the Department of Health and Human Services, which oversees the drug agency. 

Brenner will lead the FDA until a permanent commissioner is installed. President Donald Trump has nominated Johns Hopkins surgeon Marty Makary to run the FDA, but he has not yet been confirmed by the Senate.

Confirmation hearings for Robert F. Kennedy Jr., who, as Trump’s pick to run the Department of Health and Human Services, would be Makary’s boss, are scheduled for Jan. 29 and Jan. 30.

Brenner has worked in the FDA’s medical devices branch, most recently as chief medical officer for in vitro diagnostics and associate director for medical affairs. A preventive medicine physician, Brenner has been at the agency since 2019, according to her LinkedIn page, and helped coordinate diagnostic standards and policy as part of HHS’ response to COVID-19.

Brenner was previously a senior policy advisor at the White House Office of Science and Technology Policy during the first Trump administration.

Former FDA Commissioner Robert Califf stepped down on Jan. 20, when Trump took office. Namandjé Bumpus, the FDA’s second-in-command, left at the end of last year. Other senior officials have recently retired as well, including Patrizia Cavazzoni, director of the agency’s main drug review office. 

In his parting comments to staff, Califf emphasized the importance of post-market evidence and warned that “misinformation is precipitating a major public health crisis.” In a recent interview with Stat, Califf also raised concerns that agency staff may depart under the new administration.

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