FDA Leadership Transition: Sara Brenner Named Acting Commissioner Amid Broader Agency Changes

The U.S. Food and Drug Administration (FDA) has entered a period of transition as Sara Brenner assumes the role of acting commissioner, following the departure of Robert Califf. This change comes as the agency awaits Senate confirmation of President Donald Trump's nominee for permanent commissioner, Johns Hopkins surgeon Marty Makary.

Brenner's Appointment and Background

Sara Brenner, previously the chief medical officer for in vitro diagnostics and associate director for medical affairs within the FDA's Center for Devices and Radiological Health, has been tapped to lead the agency on an interim basis. Brenner's appointment was confirmed through an update to the FDA's leadership biography page, though the agency declined to comment further, citing a communications pause imposed by the Department of Health and Human Services (HHS).

Brenner brings a wealth of experience to the role, having joined the FDA in 2019. During the COVID-19 pandemic, she played a crucial role in coordinating diagnostic standards and policy as part of the HHS response. Prior to her FDA tenure, Brenner served as a senior policy advisor at the White House Office of Science and Technology Policy during the first Trump administration.

Broader Leadership Changes and Confirmation Hearings

The leadership transition at the FDA is part of a larger shake-up within the health sector of the federal government. Robert F. Kennedy Jr., President Trump's nominee for HHS Secretary, is scheduled for confirmation hearings on January 29 and 30 before the Senate's finance and health committees, respectively.

These changes come amid several high-profile departures from the FDA. In addition to Califf's exit on January 20, Namandjé Bumpus, the FDA's second-in-command, left at the end of last year. Other senior officials, including Patrizia Cavazzoni, director of the agency's main drug review office, have also recently retired.

Califf's Parting Words and Agency Priorities

In his farewell remarks, outgoing Commissioner Robert Califf emphasized several key areas of focus for the FDA. He highlighted the importance of post-market evidence gathering, the agency's work in regulating artificial intelligence in medical devices, and the critical need to combat misinformation in public health.

Califf expressed concern about the impact of misinformation, stating, "I continue to believe that misinformation is precipitating a major public health crisis." He also noted that the FDA is at the forefront of advancing technologies with significant potential impacts on human health, including gene editing and artificial intelligence.

In a recent interview, Califf raised concerns about potential staff departures under the new administration, highlighting the challenges the FDA may face in maintaining continuity and expertise during this transition period.