Sara Brenner Named Acting FDA Commissioner Amid Leadership Transition

In a significant shift at the helm of the U.S. Food and Drug Administration (FDA), Sara Brenner has been appointed as the agency's acting commissioner. This move comes as part of a broader leadership transition following the recent change in administration.

Brenner's Appointment and Background

Sara Brenner, previously serving in the FDA's Center for Devices and Radiological Health, has stepped into the role of acting commissioner. Her most recent position was as chief medical officer for in vitro diagnostics and associate director for medical affairs. Brenner, a preventive medicine physician, joined the FDA in 2019 and played a crucial role in coordinating diagnostic standards and policy during the COVID-19 response.

Prior to her FDA tenure, Brenner held the position of senior policy advisor at the White House Office of Science and Technology Policy during the first Trump administration. Her appointment to lead the FDA, albeit in an acting capacity, marks a significant milestone in her career in public health and regulatory affairs.

Leadership Transition and Nomination Process

The leadership change at the FDA is part of a broader transition in the wake of the recent presidential inauguration. Former FDA Commissioner Robert Califf stepped down on January 20, 2025, coinciding with President Donald Trump's return to office. Namandjé Bumpus, who served as the FDA's second-in-command, had already departed at the end of the previous year.

President Trump has nominated Johns Hopkins surgeon Marty Makary as the permanent FDA commissioner. However, Makary's confirmation by the Senate is still pending. The confirmation process is further complicated by the upcoming hearings for Robert F. Kennedy Jr., Trump's nominee to lead the Department of Health and Human Services (HHS), scheduled for January 29 and 30. As the potential head of HHS, Kennedy would oversee the FDA and, by extension, become Makary's superior.

Challenges and Concerns

The transition period has not been without its challenges. In his parting comments, former Commissioner Califf emphasized several critical areas of focus for the FDA, including the importance of post-market evidence, the agency's work in regulating artificial intelligence in medical devices, and the growing threat of misinformation in public health.

Califf also expressed concerns about potential staff departures under the new administration, highlighting the importance of maintaining institutional knowledge and expertise during this transition period. These concerns underscore the challenges facing Brenner as she takes on the role of acting commissioner, tasked with guiding the agency through a period of significant change while maintaining its core functions and responsibilities.