Dr. Sara Brenner, who has been FDA CDRH’s in vitro diagnostics chief medical officer, is serving as acting commissioner of the agency.
That’s according to a recent update to the agency’s leadership profiles. The FDA, which has been under a communications freeze under the new Trump administration, did not immediately respond to MassDevice requests for comment.
Brenner is serving as acting commissioner while President Donald Trump’s nominee for the post, Johns Hopkins University surgeon Dr. Martin Makary, awaits U.S. Senate confirmation.
According to her FDA biography, Brenner is a preventive medicine and public health physician whose experience included working at HHS to coordinate government efforts on medical countermeasures, technological innovation, regulation, public health preparedness, and data analytics over two administrations during the COVID-19 pandemic.
From 2018 to 2019, during the first Trump administration, Brenner served as senior policy advisor for health and biomedical innovation at the White House Office of Science and Technology Policy.
Brenner has an MD from the University of Iowa Carver College of Medicine, an MPH from the SUNY UAlbany School of Public Health (Health Policy and Administration), and a BS in genetics (minor in philosophy) from Iowa State University.
As acting director, Brenner is managing the FDA through a host of changes under the incoming administration, including withdrawal from the World Health Organization, a regulatory freeze pending review, the ending of diversity, equity, and inclusion efforts, and more. Axios reports of medical researchers and scientists rattled by the moves, wondering if they signal a broader anti-science agenda.
At a November interview at the Friends of Cancer Research annual meeting, outgoing FDA Commissioner Robert Califf said industry support will be the biggest factor in keeping talented employees at the FDA under Trump.
CDRH Director Dr. Michelle Tarver, who took over as the agency’s top medtech regulator last year, issued a statement near the end of the Biden administration urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the supply chain.
In announcing his departure on X on Inauguration Day, Califf said: “The hard work we have made in terms of structural changes will help us better deal with future challenges. Commissioners come and go, but this workforce is the foundation for much of American health and well-being. You can be sure that I will be cheering them on from the sidelines and looking to help where I can.”
