Sara Brenner named acting FDA commissioner

Sara Brenner, a Food and Drug Administration official in the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made online to the regulator’s leadership biography page.

The FDA declined to comment, citing a communications pause by the HHS.

Brenner will lead the agency until a permanent commissioner is installed. President Donald Trump has nominated Johns Hopkins surgeon Marty Makary as FDA commissioner, 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 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’ COVID-19 response. 

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

Former FDA Commissioner Robert Califf stepped down on Jan. 20, Trump’s inauguration day. Namandjé Bumpus, the FDA’s second-in-command, left at the end of last year.

In his parting comments, Califf emphasized the importance of post-market evidence, the device center’s work in regulating artificial intelligence 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.