Biden Brings Robert Califf Back to FDA

November 30, 2021 by Alec Stone MA, MPA, Former ONS Director of Government Affairs and Advocacy

Citing his extensive medical background and leadership experience, in November 2021, President Joe Biden nominated (https://www.whitehouse.gov/briefing-room/statements-releases/2021/11/12/statement-from-president-joe-biden-announcing-his-intention-to-nominate-dr-robert-califf-for-commissioner-of-food-and-drugs/) Robert Califf (https://medicine.duke.edu/faculty/robert-m-califf), MD, MACC, adjunct professor of medicine, professor of cardiology, and member of the Duke Clinical Research Institute at the Duke University School of Medicine in Durham, NC, as U.S. Food and Drug Administration (FDA) commissioner. Califf will assume the role once confirmed by the U.S. Senate.

“Califf is an internationally recognized expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine,” Biden said (https://www.whitehouse.gov/briefing-room/statements-releases/2021/11/12/statement-from-president-joe-biden-announcing-his-intention-to-nominate-dr-robert-califf-for-commissioner-of-food-and-drugs/). “He brings nearly four decades of experience as a physician, researcher, leader, and public servant, including previous service as FDA commissioner from 2016–2017.”

Califf is also (https://medicine.duke.edu/faculty/robert-m-califf) a current member of the National Academy of Medicine and former member of the FDA Cardiorenal Advisory Panel, FDA Science Board’s Subcommittee on Science and Technology, and several other national boards and advisory panels. In those roles, he led initiatives to improve methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative, a public-private partnership co-founded by FDA and Duke University.

Once Califf’s nomination is confirmed, he would replace Acting FDA Commissioner Janet Woodcock (https://www.fda.gov/about-fda/fda-organization/janet-woodcock), MD, who has served in the position since January 20, 2021.

“I urge the Senate to move quickly to confirm Califf’s nomination in support of our ongoing work tackling the COVID-19 coronavirus and more,” U.S. Health and Human Services Secretary Xavier Becerra said (https://www.hhs.gov/about/news/2021/11/12/statement-from-secretary-xavier-becerra-on-president-bidens-intention-to-nominate-dr-robert-califf-for-commissioner-fda.html). “Califf knows the job and is ready for the challenge. Woodcock, acting FDA commissioner, has been instrumental in the Biden-Harris administration in leading FDA through these challenging times. We will continue to be on solid footing because of her continued leadership and focus on strengthening FDA and supporting its workforce.”


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