FDA's diagnostics CMO named interim agency commissioner

The FDA has tapped Sara Brenner to serve as acting commissioner as it awaits new leadership from the Trump administration to complete the congressional confirmation process.

Brenner was most recently the agency’s chief medical officer for in vitro diagnostic tests, and associate director for medical affairs within the Center for Devices and Radiological Health.

Prior to that, during the COVID-19 pandemic emergency, she served as the diagnostic data lead for a workgroup in the Department of Health and Human Services (HHS), according to her agency biography, and also held the role of senior policy adviser in the White House’s Office of Science and Technology Policy.

The FDA’s previous chief, Robert Califf, M.D., stepped down on Jan. 20 during the presidential transition.

In a long post on X, Califf reflected on his second stint as commissioner: “I had no intention of returning to the FDA when I departed in January 2017,” he said. “But when the call came in late 2021 to return to public service, I couldn’t refuse.”

“I was driven by the mission of service to the public, the tremendous people at the FDA, and the recognition that there was an opportunity to contribute to public health in the waning years of my career,” he said. “As I prepare to say farewell again, I feel that we have made major progress on behalf of the American public. And this is due in great part to the FDA workforce and their hard work, integrity and focus on the mission.”

Califf said he left an agency on the cusp of advancing technologies that will have major impacts on human health—including gene editing and artificial intelligence—but that the FDA is also “losing the battle” against misinformation.

“I continue to believe that misinformation is precipitating a major public health crisis,” he wrote, adding that “seeking and promoting the truth is a core foundation of the FDA’s work.”

Last November, Donald Trump named Johns Hopkins surgeon and author Martin Makary as his pick for FDA commissioner—a post that will require a confirmation vote in the Senate, following hearings that have not yet been scheduled.

This week, the Senate’s finance and health committees will consider Trump’s nomination of Robert F. Kennedy, Jr. to be HHS secretary, with hearings on January 29 and 30, respectively.