Califf Confirmed by Senate in Slim-margin Vote

The U.S. Senate voted 2/15 to confirm Robert Califf as the next FDA commissioner by a slim-margin vote of 50 to 46. He previously served as FDA head during the last year of the Obama presidency in 2016 after clearing the Senate in an 89-4 vote. Acting commissioner Janet Woodcock has confirmed she will be transitioning to second in command as principal deputy commissioner once Califf is sworn in, which is likely to happen shortly.

Califf endured significant resistance from four Democrats and one Independent, who opposed him in the final vote — Sens. Joe Manchin (D-WV), Richard Blumenthal (D-CT), Maggie Hassan (D-NH), Ed Markey (D-MA) and Bernie Sanders (I-VT). The lawmakers’ opposition was mainly due his past consulting work with drug companies and the agency’s record addressing the opioid epidemic. But in the end, the vote was salvaged by support from six Republicans — Mitt Romney (R-UT), Susan Collins (R-ME), Lisa Murkowski (R-AK), Roy Blunt (R-MO), Patrick Toomey (R-PA), and Richard Burr (R-NC).

During the confirmation process, Califf vowed to crack down on drug companies that gain accelerated approval and then fail to adequately pursue confirmatory evidence as required by the agency in postmarketing commitments (see earlier story). He said that within 30 days of taking office he will “take strong action to hold companies accountable for producing the required scientific evidence after obtaining accelerated approval.” Califf also agreed to significant ethics commitments (see story). In a 1/27 letter to Senator Elizabeth Warren (D-MA), he committed to recuse himself from matters involving his former employers and clients for four years — two years longer than what is required in the Biden-Harris administration’s ethics pledge. He also agreed not to seek employment with or compensation from any pharmaceutical or medical device company that he interacts with during his tenure as FDA commissioner for four years after completing his government service.

At his confirmation hearing, Califf said he was going to be very aggressive in the area of medical misinformation on social media (see earlier story). Califf’s hard line on social media promotions came in response to a question during his 12/14/2021 Senate Health, Education, Labor & Pensions Committee confirmation hearing from Senator John Hickenlooper (D-CO) on whether FDA needs to take a more active role ensuring that there’s sufficient oversight of direct-to-consumer (DTC) advertising. Califf strongly agreed there should be more DTC oversight. He said he and other physicians do not like that there’s advertising of drugs, “but we don't make those laws. So the FDA has to regulate it, and I think we need an across-the-board update and a much more active FDA in terms of getting the right information to the public.”

In his opening statement at the hearing, Califf said the current state of the agency and the U.S. is a “once-in-a-generation time for public health.” He said his priorities if confirmed would be emergency preparedness and response; consumer and patient protection; and modernization and innovation. As his first priority, he said: “FDA must continue to be a strong partner in battling Covid-19, taking into account lessons learned from the pandemic so we can apply them to the ongoing current pandemic so we are ready for the next one.”

Reacting to the confirmation, Friends of Cancer Research said the U.S. is at a pivotal moment for public health, and the “leadership Dr. Califf will bring to the FDA will be paramount to assuring the safety, effectiveness, and security of human drugs, and helping to speed innovations that make medicines more effective, safer, and more affordable... His in-depth work in clinical research and health outcomes research brings lived experience to the agency that will deeply inform his work.” The Alliance for a Stronger FDA had this to say: “The Food and Drug Administration is important to our nation’s health and its economy, which is why we believe it is so critical to have a Senate-confirmed commissioner. We congratulate Dr. Califf and send our thanks to those who made his confirmation possible.”