FDA appoints diagnostics CMO Sara Brenner as acting commissioner

USA – The U.S. Food and Drug Administration (FDA) has appointed Sara Brenner as its acting commissioner while awaiting the confirmation of new leadership under the Trump administration.

Brenner brings a wealth of experience to the role, having previously served as the FDA’s chief medical officer for in vitro diagnostic tests and associate director for medical affairs within the Center for Devices and Radiological Health.

During the COVID-19 pandemic, Brenner played a pivotal role as the diagnostic data lead for a workgroup at the Department of Health and Human Services (HHS).

Additionally, she served as a senior policy adviser in the White House’s Office of Science and Technology Policy, showcasing her expertise in navigating complex health crises and policymaking.

This leadership change follows the departure of Robert Califf, M.D., who stepped down as FDA commissioner on January 20 during the presidential transition.

Reflecting on his tenure in a detailed post on X, Califf shared his motivations for returning to the agency in late 2021, stating, “I had no intention of returning to the FDA when I departed in January 2017. But when the call came… I couldn’t refuse.”

Califf emphasized the progress made during his leadership, attributing much of the success to the dedicated FDA workforce.

“As I prepare to say farewell again, I feel that we have made major progress on behalf of the American public,” he said.

He highlighted advancements in transformative technologies like gene editing and artificial intelligence but expressed concern about the growing challenge of misinformation, describing it as a “major public health crisis.” He noted that “seeking and promoting the truth is a core foundation of the FDA’s work.”

As Brenner assumes the acting commissioner role, the FDA awaits the confirmation of Martin Makary, a Johns Hopkins surgeon and author nominated by President Donald Trump.

Makary’s appointment as FDA commissioner requires a Senate confirmation vote, although hearings have not yet been scheduled.

Meanwhile, this week, the Senate’s finance and health committees will deliberate on Trump’s nomination of Robert F. Kennedy, Jr. for HHS secretary, with hearings slated for January 29 and 30.