Feb. 15, 2022 – Dr. Robert Califf was confirmed to be the next Commissioner of Food and Drugs in a close 50-46 Senate vote today. In a sign of the times, during the 2016 vote for Califf’s first stint as FDA Commissioner, he was confirmed 89-4.

“We expect Califf to be a strong leader for the FDA, and it is important that the agency finally has a new Commissioner,” said Coalition for Healthcare Communication Executive Director Jon Bigelow.

Prior to the vote, there was last-minute scrambling for votes among those who supported Califf and those who did not. Supporters touted Califf’s prior FDA experience and credentials as a leader in clinical research. Some senators remained suspicious of Califf’s biopharma relationships, but in recent days he picked up support by reassuring uncommitted senators on their hot-button issues, which included ties to biopharma companies, pushing companies to promptly conduct follow-up trials on products approved through the accelerated pathway, and taking strong action against vaping devices.

Those who opposed Califf were critical of what they called his lack of action to address the opioid crisis, and pro-life activists campaigned against Califf following the FDA’s recent decision to allow abortion pills to be sent by mail. (For additional details on these issues, see our previous coverage.) In the end, Califf lost the votes of five Democrats but won those of six Republicans.

And now, “the work begins,” Bigelow said in an CHC Industry Leaders Alert. “A first task for the new Commissioner is to reinvigorate an agency that, amidst the COVID-19 pandemic, has been the target of unprecedented political attacks and gone without a Senate-confirmed leader for nearly 13 months,” Bigelow stated.

Beyond that—as Kate Rawson, senior editor of Prevision Policy, outlined in a Coalition webinar this afternoon—the early issues facing the FDA include:

• Resolving difficult questions related to approvals of COVID-19 vaccines and drugs;
• Finding ways to combat the continuing opioids epidemic;
• Tightening the confirmatory study requirements behind the accelerated pathway that led to the controversial approval of Aduhelm for Alzheimer’s disease;
• Reducing the serious backlog in inspections of manufacturing facilities, especially overseas;
• Getting the Prescription Drug User Fee Act VII (and companion bills) through Congress by the Oct. 1 start of the next fiscal year;
• Dealing with delayed decisions on vaping devices; and
• Recruiting to reduce the chronic staffing shortages.

Dr. Janet Woodcock, who has served as Acting Commissioner for the past year, confirmed today that she will stay on as Principal Deputy Commissioner, “which should allow Califf the bandwidth to focus on the top priorities,” according to Bigelow.