Robert Califf, MD Confirmed FDA Commissioner By US Senate

US Food and Drug Administration

The US Senate has confirmed Robert Califf, MD, as the newest commissioner of the US Food and Drug Administration (FDA) in a narrow 50-46 vote.

In Califf’s second confirmation as head of the FDA, 6 Republicans supported the confirmation, while 5 Democrats opposed.

Califf previously served as commissioner during the Obama Administration and was nominated by President Joe Biden to replace acting commissioner Janet Woodcock, MD, last November. Woodcock had been serving in the role since the resignation of Stephen Hahn, MD, at the end of the Trump administration in January 2021.

By mid-November, Woodcock was legally unable to remain as acting commissioner and the Biden administration nominated Califf.

A cardiologist by trade, Calif was appointed Deputy Commissioner of the FDA Office of medical products and Tobacco in 2015, following a 35-year career at Duke University. Califf was previously confirmed as FDA commissioner with an 89-4 vote and served from February 2016 - January 2017.

According to a report by The New York Times, concerns surrounding Califf’s potential response to the opioid epidemic and the FDA’s handling of abortion drug rules loomed over the confirmation vote. Some senators called on the senate to confirm Califf, citing the long stretch without a permanent leader, including Senator Richard Burr, R-North Carolina.

“I urge my colleagues to support Dr. Califf’s nomination because he will provide the leadership needed to promote today’s biomedical advancements and help to pave the way for tomorrow’s innovation,” Burr said.

Others expressed wariness of Califf’s ties to the pharmaceutical industry. Senator Edward Markey, D-Massachusetts, noted the FDA’s role in the opioid crisis and cited a lack of response during Califf’s previous tenure in the FDA.

“There was no real commitment to reforming the FDA or to learning from the mistakes that enabled this public health crisis,” Markey said.

Califf’s tenure additionally comes as the agency grapples with the review of COVID-19 vaccines for young children and supporters back the call for permanent leadership during these health crises.

“Dr. Califf’s previous service in this role, his career as one of the nation’s leading research scientists, gives him the experience to take on this challenge,” said Senator Patty Murray of Washington, the chairwoman of the Senate Committee on Health, Education, Labor and Pensions.

More high-profile decisions are forthcoming for Califf, including decisions on e-cigarette marketing applications, new drug approvals, and a backlog of foreign inspections of active drug ingredients.