Robert Califf, MD, Named FDA Deputy Commissioner

January 26, 2015—The US Food and Drug Administration (FDA) announced that FDA Commissioner Margaret A. Hamburg, MD, has appointed Robert Califf, MD, as FDA deputy commissioner for medical products and tobacco. He will join the FDA in late February.

The FDA noted that Dr. Califf is a recognized global leader in cardiology, clinical research, and medical economics. He is currently serving as Vice Chancellor of Clinical and Translational Research at Duke University in Durham, North Carolina.

As FDA Deputy Commissioner, Dr. 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. Additionally, he will oversee the Office of Special Medical Programs in the Office of the Commissioner.

According to the FDA, Dr. Califf will play a critical role in providing high-level advice and policy direction on the agency’s medical product and tobacco priorities and will manage cross-cutting clinical, scientific, and regulatory initiatives in several key areas for the agency, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system.

In the FDA announcement, Commissioner Dr. Hamburg commented, “I am delighted to announce this important addition to FDA’s senior leadership team. 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.”

The FDA stated that other prominent roles during Dr. Califf’s tenure at Duke include Director of the Duke Translational Medicine Institute and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. Before serving as Director of the Duke Translational Medicine Institute, he was the founding Director of the Duke Clinical Research Institute, the world’s largest academic research organization. Dr. Califf is recognized by the Institute for Scientific Information as one of the top ten most cited medical authors, with more than 1,200 peer-reviewed publications.

During his career, Dr. Califf has led many landmark clinical studies. He is a nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research. He is one of our nation’s leaders in the growing field of translational research, which is key to ensuring that advances in science translate into medical care. He was a member of the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market and of the IOM’s Committee on Identifying and Preventing Medication Errors. In addition, he served as a member of 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 liaison to the Forum in Drug Discovery, Development, and Translation, advised the FDA.