FDA Commissioner Margaret A. Hamburg, M.D., on Tuesday appointed Robert Califf, M.D., a recognized global leader in cardiology and clinical research, as FDA Deputy Commissioner for Medical Products and Tobacco. In this position, Dr. Califf will be in charge of FDA’s 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 oversee the Office of Special Medical Programs 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 personalized medicine, orphan drugs, pediatric science, and the advisory committee system,” states FDA in its press release.
Given the large roll Dr. Califf will be taking on, many have speculated that he could be in line to be FDA Commissioner after Hamburg retires. “[Califf] is a guy who could very easily be FDA commissioner under any administration,” said Peter Pitts, the FDA’s former associate director for external relations. “He is one of the few candidates who could sail through the confirmation process because of his universally recognized talents.” (Reuters) FDA commissioners are appointed by the president and approved by the Senate, but Hamburg could be trying to “ease Califf in before a new administration takes over in 2017,” speculates Fierce Biotech.
“I am delighted to announce this important addition to FDA’s senior leadership team,” said Hamburg. “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.”
Dr. Califf is currently the director of the Duke Translational Medicine Institute (DTMI), and founded the Duke Clinical Research Institute (DCRI), the largest academic research organization in the world and a frequent collaborator with FDA. Under his leadership, DCRI grew to 1,000 employees with an annual budget of $100 million, notes David Kroll of Forbes. Furthermore, Hamburg notes that “Dr. Califf 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.”
C. Michael Gibson, MD, professor of medicine at Harvard was very happy with Califf’s appointment: “Patients and healthcare providers are fortunate to have someone who has not only a tremendous breadth and depth of knowledge but also someone who has such sound judgement in this position. I can think of no individual better suited for this role.”
“This is a great catch for the FDA,” said Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic (as reported in MassDevice). “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.”
During his career, Califf has worked closely with industry on significant clinical trials, and is a recognized clinical-research expert. Shortly following the FDA announcement, Portola Pharmaceuticals announced that Califf had retired from his position on the company’s Board of Directors.