Senate Confirms Califf as FDA Commissioner

WASHINGTON — By a vote of 50-46, the Senate on Tuesday voted to confirm Robert Califf, MD, as commissioner of the FDA, returning him to his prior position in an unusually close vote.

Califf is the head of clinical and policy strategy for Verily Life Sciences, and was a professor of cardiology at the Duke University School of Medicine in Durham, North Carolina. He previously served as FDA commissioner from February 2016 to January 2017, confirmed by the Senate in a vote of 89-4.

Unlike many Senate votes, this one did not proceed entirely along party lines. For example, Sen. Mitt Romney (R-Utah) voted in favor of the nominee, while Sen. Maggie Hassan (D-N.H.) voted no.

At a nomination hearing held in December by the Senate Health, Education, Labor and Pensions (HELP) Committee, Hassan — whose state has been hit hard by the opioid epidemic — asked Califf why he had not taken steps to revise the label for the controversial and highly addictive opioid Oxycontin. Califf responded that the agency would “aggressively” pursue relabeling the drug.

The committee voted 13-8 in January to send Califf’s nomination on to the Senate floor. In a press statement the day before that vote, Hassan again underscored that the next FDA commissioner should acknowledge the agency’s role in “fueling this crisis. After careful review of Dr. Califf’s record, including questioning him during last month’s nomination hearing, it does not appear that things would be different under his leadership and I will be voting no on his nomination.”

At the December hearing, Sen. Bernie Sanders (I-Vt.), who also voted against Califf’s nomination, highlighted the “several hundred thousand dollars” that Califf made from pharmaceutical companies after leaving the FDA, as well as his stock portfolio of “up to $8 million” in major pharmaceutical company stock. Given his industry ties, Sanders questioned whether Califf would be “an independent and strong voice” for the agency.

Sanders and Sen. Joe Manchin (D-W.Va.), another senator opposed to Califf, penned an op-ed in last Friday’s issue of USA Today urging President Biden to withdraw Califf’s nomination because of his poor handling of the opioid crisis. “Given the dire situation facing our communities, it makes absolutely no sense to install a candidate who has already led the FDA in its most senior position but failed to address this crisis in any meaningful way,” Sanders and Manchin wrote. “We need new, dedicated leadership that understands the gravity of the drug epidemic and will fight back against the greed of the pharmaceutical industry.”

HELP Committee chair Sen. Patty Murray (D-Wash.), on the other hand, supported Califf’s nomination. “Dr. Califf’s previous service in this role, and his career as one of the nation’s leading research scientists, give him the experience to take on this challenge,” she said Monday night, shortly before the Senate voted to end debate on the Califf nomination. “The FDA needs strong leadership to continue [its] work … [FDA staff] deserves a Senate-confirmed leader with experience on these issues to lead those efforts. I urge all of my colleagues to join me in voting to confirm Dr. Califf.”

Califf’s actions related to abortion also have been the subject of some controversy. At the December hearing, Sen. Mike Braun (R-Ind.) and other Republicans questioned Califf on what they characterized as the agency’s weakening of the Risk Evaluation and Mitigation Strategy (REMS) for the abortion drug mifepristone (Mifeprex). In April 2021, the FDA announced that they would employ a policy of “enforcement discretion” around the requirements for in-person dispensing of the drug, which allowed patients to receive it by mail.

In December, Califf said his top priority as commissioner would be to focus on emergency preparedness and response, as well as to ensure the safety of the food and drug supply, curb the opioid epidemic, develop a “systematic approach” to evidence generation, protect children from tobacco products, and help retain and attract new talent to the FDA’s scientific workforce.