Nov. 12, 2021 -- President Joe Biden on Friday said he will nominate Robert Califf, MD, to be commissioner of the FDA, the top U.S. 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 who would be Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, a FDA veteran, has been serving as acting commissioner. The White House faces a Tuesday deadline to make a nomination or see Woodcock’s tenure as acting chief expire under federal law.

The White House earlier appeared to test the idea of a Califf nomination, with speculation reported in October. 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 a potential nomination of Califf.

Michael Carome, MD, director of Public Citizen’s Health Research Group, said the U.S. “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 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 research, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation, also important.”
Long affiliated with Duke University and a well-published researcher with extensive experience in clinical trials, Califf now is head of clinical policy and strategy for Verily and Google Health, according to that organization's website.

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