US Food and Drug Administration Commissioner Margaret A. Hamburg, MD, appointed Robert Califf, MD, a recognised global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco.  

In this position, Dr. Califf will provide executive leadership to the Centre for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Centre for Devices and Radiological Health and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programmes in the Office of the Commissioner. 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 personalised medicine, orphan drugs, paediatric science, and the advisory committee system.

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

Dr. Califf is currently serving as vice chancellor of clinical and translational research at Duke University. Other prominent roles during his tenure at Duke include director of the Duke Translational Medicine Institute (DTMI), and professor of medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. Before serving as director of DTMI, he was the founding director of the Duke Clinical Research Institute, the world’s largest academic research organisation. Dr. Califf is recognised by the Institute for Scientific Information as one of the top 10 most cited medical authours, with more than 1,200 peer-reviewed publications.

During his career, Dr. Califf has led many landmark clinical studies, and is a nationally and internationally recognised 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. Currently, he is a member of the IOM Policy Committee and liaison to the Forum in Drug Discovery, Development, and Translation.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human drugs, including vaccines and other biological products for human use, veterinary drugs, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.