President Biden Nominates Cardiologist Robert Califf for FDA Commissioner

President Joe Biden today announced his intention to nominate cardiologist Robert Califf, M.D., MACC, for the position of commissioner of food and drugs to lead the U.S. Food and Drug Administration (FDA).

President Joe Biden has nominated cardiologist Robert Califf, M.D., MACC, for the position of commissioner of food and drugs to lead the U.S. Food and Drug Administration (FDA).

November 12, 2021 — President Joe Biden today announced his intention to nominate cardiologist Robert Califf, M.D., MACC, for the position of commissioner of food and drugs to lead the U.S. Food and Drug Administration (FDA).

He previously served in the commissioner position under the Obama administration between February 2016, and January 20, 2017. Califf, age 70, is currently working as vice chancellor for clinical and translational research at Duke University, and as a senior advisor for Verily Life Sciences and Google Health

His nomination comes when the FDA is facing serious challenges with the continuing COVID-19 pandemic in addition to the normal workload of the agency. His nomination is seen by many in Washington as a way to put an experienced physician who has already performed the job and who has a long history of clinical trial experience in this position.

"Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic," said President Biden in a statement on the nomination. "As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA. I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making."

Califf had strong bipartisan support in the Senate during his 2016 confirmation, so Biden is hoping the nominee will have smooth sailing through Congressional approval.

Califf was the founding director of the Duke Clinical Research Institute. He also is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality and clinical research. He led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with 1,250 publications in the peer-reviewed literature.

Califf is a member of the National Academy of Medicine (formerly the Institute of Medicine [IOM]) and served on numerous IOM committees. He was also a member of the FDA Cardio-Renal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology. Califf has also served on the Board of Scientific Counselors for the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences, and the Council of the National Institute on Aging.

He has led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke.

He served as the principal investigator for Duke's Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center, and as co-principle investigator of the National Patient-Centered Clinical Research Network (PCORnet).

Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.

"Califf is an internationally recognized expert in clinical trial research, health disparities, healthcare quality and cardiovascular medicine. He brings nearly four decades of experience as a doctor, researcher, leader and public servant," Biden said.