Robert M. Califf Becomes 25th Commissioner of the US FDA

Cardiologist Robert M. Califf, MD, will return as commissioner of the US Food and Drug Administration following his Senate confirmation today. Califf, who headed the agency for just under a year in 2016 and 2017, was chosen by President Joe Biden to replace interim commissioner Janet Woodcock, MD.

The vote was narrow, 50 to 46, with only six Republicans voting in Califf’s favor and five Democrats voting against him. Some, like Senator Maggie Hassan (D-NH), are worried that Califf’s ties to industry mean he won’t be aggressive enough in fighting the opioid crisis. Hassan, who voted against Califf’s confirmation, said in a statement that she has “serious concerns about the FDA’s role in fueling this crisis through its handling of opioid approvals and labeling, including during Dr. Califf’s time at the agency.”

Since Biden nominated Califf in November 2021, however, multiple medical societies, including the American Heart Association (AHA), the American College of Cardiology (ACC), and the Association of Black Cardiologists (ABC), have voiced their support for him, emphasizing the need for a permanent FDA leader.

“He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research to prioritize science and evidence-based policy-making,” said AHA CEO Nancy Brown today in a press release congratulating Califf. “His previous leadership of the FDA will enable him to hit the ground running and ensure the agency can meet the current public health threats,” Brown added.

An experienced clinical trialist, the 70-year-old Califf was vice chancellor of clinical and translational research and director of the Duke Translational Medicine Institute in Durham, NC, and the founding director of the Duke Clinical Research Institute.