Sara Brenner appointed Acting FDA Commissioner amid leadership transition

USA – Dr. Sara Brenner, a preventive medicine and public health physician, has been appointed as the Acting Commissioner of the U.S. Food and Drug Administration (FDA).

She steps into the role following the departure of former Commissioner Dr. Robert M. Califf. 

She will lead the agency until the Senate confirms President Donald Trump’s nominee for the position, Dr. Marty Makary, a Johns Hopkins surgeon.

Extensive background in medical regulation and public health

Dr. Brenner brings a wealth of experience in diagnostics, regulation, health policy, and public health preparedness. 

Most recently, she served as Chief Medical Officer for In Vitro Diagnostics and Associate Director for Medical Affairs at the FDA’s Center for Devices and Radiological Health. 

In this capacity, she played a critical role in overseeing regulatory compliance and surveillance for medical devices while also contributing to broader public health initiatives.

During the COVID-19 pandemic, she was deeply involved in national response efforts, particularly in diagnostics, data management, and interagency coordination. 

Between February 2020 and May 2023, she served as the Diagnostic Data Lead for the U.S. Department of Health and Human Services (HHS) Data Strategy and Execution Workgroup, focusing on enhancing data-driven decision-making during the crisis.

Experience in federal policy and higher education

Before joining the FDA, Dr. Brenner held a senior policy advisory role at the White House Office of Science and Technology Policy. 

She collaborated with multiple federal agencies and the Executive Office of the President to shape national policies on healthcare, medical technology, and biomedical research. Her policy contributions extended to early-stage innovation, workforce training, and medical ethics.

Her academic career includes tenure at the State University of New York (SUNY) Polytechnic Institute’s Colleges of Nanoscale Science and Engineering. 

She served as an Associate Professor of Nanobioscience, Assistant Vice President for NanoHealth Initiatives, and Director of the M.D./Ph.D. Program in Nanomedicine. Her research interests spanned nanomedicine, medical diagnostics, and public health technologies.

Educational background and recognitions

Dr. Brenner holds an M.D. from the University of Iowa Carver College of Medicine and an M.P.H. from the SUNY University at Albany School of Public Health. 

She completed her undergraduate studies in genetics at Iowa State University. Her clinical training includes Internal Medicine at Evanston Northwestern in Chicago and Preventive Medicine and Public Health at the New York State Department of Health and SUNY Albany.

Her contributions to federal health policy and data strategy have earned her several accolades, including the 2023 Distinguished Achievement in Federal Data and Policy Award from HHS and the 2021 COVID-19 Pandemic Civilian Service Medal.

FDA leadership transition under new administration

Dr. Brenner assumes leadership amid a broader transition at the FDA following Dr. Califf’s resignation on January 20. Deputy Commissioner Namandjé Bumpus also stepped down at the end of 2023. 

As the new administration takes shape, uncertainty looms over potential staffing changes within the agency.

In his final remarks, Dr. Califf highlighted key challenges facing the FDA, particularly in post-market evidence collection and the regulation of artificial intelligence in medical devices. 

He also warned about the growing impact of misinformation on public health, a concern that remains a focal point for the agency’s regulatory and public outreach efforts.

As the Senate prepares to hold confirmation hearings for Dr. Makary’s nomination, Dr. Brenner’s interim leadership will oversee critical regulatory activities and public health initiatives, ensuring stability during the transition period.