Medical Technology

Biden Seeks to Return Califf as FDA Chief

President Joe Biden on Friday said he will nominate Robert Califf, MD, to be commissioner of the US Food and Drug Administration (FDA), the top US regulator of drugs and medical devices.

Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from February 2016 to January 2017.

The coming nomination ends nearly 11 months of speculation over Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier — resulting in regulatory capture of the agency by industry.”

But the idea of Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Califf nomination before making it official. “I realize that this is being floated and not officially announced…but the nomination of [Califf] just makes so much sense,” Krumholz tweeted. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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