January 27, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
U.S. Food and Drug Administration (FDA) on Monday named Robert Califf, a cardiologist and researcher, as the agency’s Deputy Commissioner for Medical Products and Tobacco.
Califf is a “recognized global leader in cardiology, clinical research, and medical economics,” according to the FDA. “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,” FDA Commissioner Margaret Hamburg said in statement.
When Califf assumes the post, the most senior medical products position after the commissioner, he will be filling a position that has stood vacant for the past two years. Experts weighing in on the decision have expressed admiration for Califf and his accomplishments.
“This is a great catch for the FDA,” Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, was quoted as saying by Reuters. “Dr. Califf is one of the most eminent physician-scientists of our generation, with a reputation for scientific integrity that will serve the agency well.”
A former associate director for external relations at the FDA, Peter Pitts, echoed this assessment of Califf’s reputation. “He is a guy who could very easily be FDA commissioner under any administration,” Pitts, currently serving as president of the Center for Medicine in the Public Interest, told Reuters. “He is one of the few candidates who could sail through the confirmation process because of his universally recognized talents.”
In fact, the Bush administration interviewed Califf twice for the position of FDA commissioner, and it has been speculated that Califf is the first piece in a succession plan at the agency, according to the Wall Street Journal. The President of the US appoints the Commissioner of the FDA, however, so any succession plan will depend on next year’s presidential election.
On a conference call with reporters, Califf said that one of his priorities would be streamlining the clinical trial process, according to Reuters. The FDA cited Califf’s experience a leader in translational medicine, a field that works to translate scientific advances into medical care, as relevant factor in his appointment.
Currently serving as vice chancellor of clinical and translational research at Duke University, he has also held the position of 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, N.C. In addition, he was the founding director of Duke Clinical Research Institute, the world’s largest academic research organization. He is recognized as one of the top ten most cited medical authors, with more than with more than 1,200 peer-reviewed publications under his belt.
Califf will lead the FDA’s Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.
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