U.S. Senate Confirms Dr. Robert Califf for FDA Chief

The U.S. Senate narrowly voted to confirm Robert Califf, M.D., as U.S. Food and Drug Administration commissioner, overriding concerns about his pharmaceutical industry ties and perceived non-aggressive strategy for stemming the opioid epidemic.
 
Republican support pushed Califf across the finish line in a 50-46 vote; six GOP senators crossed party lines to endorse the prominent cardiologist, while five Democrats opposed him and one senator voted present, according to news reports. 

Califf’s confirmation was fret with controversy, as lawmakers criticized his pharmaceutical stock ownership (Verily, Centessa Pharmaceuticals, Cytokinetics, Amgen, Gilead Sciences, Bristol-Meyers Squibb), and his previous leadership of the FDA during the opioid crisis (he served as commissioner from 2016-2017). “We need new, dedicated leadership that understands the gravity of the drug epidemic and will fight back against the greed of the pharmaceutical industry,” U.S. Sens. Joe Manchin, D-W.V., and Mike Braun, R-Ind., wrote in a USA Today opinion piece.

Califf is a professor of medicine at the Duke University School of Medicine, where he previously served as vice chancellor and founded the Duke Clinical Research Institute, and also works as head of Clinical Policy at Verily Life Sciences, a life sciences research organization. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature. 

President Joe Biden, who nominated Califf, did not release a statement on the U.S. Senate’s confirmation. But two medtech industry groups congratulated Califf for surviving the nomination process and said his past experience leading the agency will serve him well as he assumes control of the fight against COVID-19 and prescription drugs.

“We congratulate Dr. Califf on his confirmation to once again lead FDA. His previous experience at the helm of the agency will serve him well as he hits the ground running during an ongoing global health crisis,” AdvaMed President and CEO Scott Whitaker said in prepared remarks. “On behalf of the medtech industry and the patients we serve, we look forward to working with the new commmissioner and his team to promote public health and continue improving patient care through innovation in life-saving medical technology. We are also deeply appreciative of Dr. Janet Woodcock’s leadership during her tenure as acting commissioner during this pandemic, and we thank her for her years of service.” 

Advamed Board Chairman Mike Minogue, who also is president, chairman, and CEO of Abiomed, added: “Dr. Califf’s confirmation is welcome news, and I congratulate him on behalf of the medtech industry and the patients we serve. Now more than ever, FDA requires steady leadership as the country emerges from the pandemic. We look forward to working with Commissioner Califf on our common goal of ensuring the innovative medical technologies patients and providers rely on are safe and effective.”

Medical Device Manufacturers Association President and CEO Mark Leahy said, “MDMA congratulates Dr. Califf on his confirmation to be the next FDA commissioner, and we look forward to working with him once again to improve patient care and strengthen the innovation ecosystem. The COVID-19 pandemic continues to highlight how important it is that policy makers and innovators collaborate to address the challenges facing patients and the healthcare delivery system, and we remain committed to working closely with FDA to help ensure the United States remains the global leader in developing lifesaving and life-changing medical technologies.”