Issue: March 2015
January 27, 2015
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Califf named FDA deputy commissioner for medical products and tobacco

Issue: March 2015
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The FDA announced that Robert Califf, MD, a leader in CV medicine, clinical research and medical economics, has been appointed as deputy commissioner for medical products and tobacco.

Califf will oversee the FDA’s Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Center for Tobacco Products and the Office of Special Medical Programs.

“I’ve always worked closely with FDA and believe in its mission,” Califf said in an interview with Cardiology Today. “My career decisions have always been made on whether I feel that my talents are best being used, my family well-being and personal happiness. In this case, the fit seemed just right.”

He will provide advice and policy direction on the FDA’s medical and tobacco priorities and will manage initiatives in areas such as personalized medicine, orphan drugs, pediatric science and the advisory committee system, according to a press release.

“My key priorities come in three tiers,” Califf told Cardiology Today. “First, helping 21st Century Cures and the next [Prescription Drug User Fee Act] negotiation to a positive conclusion. Second, supporting the excellent center directors in the many complex missions of their centers. Third, cross cutting themes, including: streamlining clinical trials, precision medicine, advisory committees and children.”

Robert Califf, MD

Robert Califf

Califf is currently the vice chancellor of clinical and translational research at Duke University. Other positions he has held at Duke include director of the Duke Translational Medicine Institute, professor of medicine in the division of cardiology at the Duke University Medical Center and founding director of the Duke Clinical Research Institute. According to the release, Califf is one of the top 10 most cited medical authors according to the Institute for Scientific Information, with more than 1,200 peer-reviewed publications.

He has also served on several committees for the Institute of Medicine and the FDA, according to the release.

“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,” Margaret A. Hamburg, MD, commissioner of the FDA, stated in the release.