FRIDAY, SEPTEMBER 30, 2016

FDA names new deputy commissioner for medical products, tobacco

Dr. Robert Califf has been named the FDA's new deputy commissioner for medical products and tobacco. | Courtesy of medicine.duke.edu

The Food and Drug Administration appointed Dr. Robert Califf on Monday as its deputy commissioner for medical products and tobacco.

Califf is a world-renowned leader in cardiology, clinical research and medical economics. He will start his new job in late February.

“I am delighted to announce this important addition to FDA’s senior leadership team,” Dr. Margaret Hamburg, the FDA's commissioner, said. “Dr. Califf’s deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve upon, the significant advances we’ve made in medical product development and regulation over the last few years.”

In his new position, Califf will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products. He will also supervise the Office of Special Medical Programs in the Office of the Commissioner and will play a key role in providing advice and policy direction on the agency’s medical product and tobacco initiatives, in addition to managing cross-cutting clinical, scientific and regulatory projects in several key areas for the agency, including personalized medicine, orphan drugs, pediatric science and the advisory committee system.

Currently vice chancellor of clinical and translational research at Duke University, Califf also has served as director of the Duke Translational Medicine Institute and as a professor of medicine in the Division of Cardiology at Duke University Medical Center. He also was the founding director of the Duke Clinical Research Institute and is recognized by the Institute for Scientific Information as one of the top 10 most-cited medical authors, with more than 1,200 peer-reviewed publications.

During his career, Califf was a member of the Institute of Medicine committees that recommended Medicare coverage of clinical trials and the removal of the diet drug ephedra from the market. He also  served on the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. He is currently a member of the IOM Policy Committee and a liaison to the Forum in Drug Discovery, Development and Translation.

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