By Omar Ford
Robert Califf, MD, is the new FDA commissioner after the agency went without a permanent leader for a little more than a year. The Senate voted 50 to 46 for the cardiologist to serve in the position.
The vote had a narrow margin, which wasn’t expected when the 71-year-old was first nominated by the Biden Administration. At the time it was thought it would be smooth sailing for Califf, because he had a brief stint as the Commissioner in 2016 and was confirmed back then 89-4 with broad bi-partisan support.
For this second go-round CNN reported five Democrats voted against cardiologist taking the position. Democratic opposition came in the form of Sen. Bernie Sanders (I-Vt.) Richard Blumenthal (Conn.),
Maggie Hassan (N.H.), Joe Manchin III (W.Va.) and Edward J. Markey (Mass.), according to The Washington Post. The reason for the opposition was because of Califf’s past work with the pharmaceutical industry.
However, medtech’s leading trade organizations were supportive of the confirmation.
In a release, AdvaMed’s President and CEO Scott Whitaker said, “We congratulate Dr. Califf on his confirmation today 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. On behalf of the medtech industry and the patients we serve, we look forward to working with the new Commissioner 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.”
Executive director of the Medical Imaging & Technology Alliiance Patrick Hope echoed similar statements in prepared remarks. Hope added, “Commissioner Califf’s leadership will also be valuable to ongoing Medical Device User Fee Act (MDUFA) amendment discussions and exploring how to best bring new medical innovations to market. MITA looks forward to continuing to collaborate on these and other efforts with the FDA.”
Califf served as FDA Commissioner from 2016-2017, for which he was confirmed by the Senate 89-4 with broad bi-partisan support. Califf also served as professor of medicine at the Duke University School of Medicine, where he previously served as Vice Chancellor and founded the Duke Clinical Research Institute.
Prior to his first stint, Califf served as the FDA’s deputy commissioner for medical products and tobacco.