Robert Califf

22nd and 25th Commissioner, FDA; Instructor in Medicine, Duke University

Robert Califf, MD, is an instructor in medicine in the Division of Cardiology at Duke University. Califf was commissioner of food and drugs at the US Food and Drug Administration (FDA) in 2016–2017 and deputy commissioner for medical products and tobacco from February 2015 until his appointment as commissioner in February 2016. Before joining the FDA, Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health-care quality, and clinical research, Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,300 publications in the peer-reviewed literature.

Califf was elected to be a member of the National Academy of Medicine, formerly known as the Institute of Medicine (IOM), in 2016, one of the highest honors in the fields of health and medicine. He has served on numerous IOM committees and as a member of the FDA Cardiorenal Advisory Panel and the 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, a public-private partnership cofounded by the FDA and Duke. He also served as principal investigator for Duke’s Clinical and Translational Science Award and for the National Institutes of Health Health Care Systems Research Collaboratory coordinating center, and as co-principal investigator of the Patient-Centered Outcomes Research Institute Network.