Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Dr. Califf Is a Data-Driven Professional Who Is Grounded in the Reality that FDA’s Mission Is to Protect and Promote the Public Health

Robert M. Califf, M.D., recently shared how his daughter gave birth to his third grandchild after a complicated pregnancy: “I was reminded about 15 times about how little evidence we have for most of what we do in medicine.”

Dr. Califf, deputy FDA commissioner for medical products and tobacco, shifted from family to agency in discussing evidence outlined in his July 29 presentation to the agency’s Science Board: “When the evidence is in, you can have arguments, but they’re a whole different type of argument than the argument you have when no one knows the right answer. But somebody has to make a decision. We have so many of those right now, it’s really a shame. Business is moving way ahead of medicine in this regard, and we’ve got to catch up.”

Nearly two months later, Dr. Califf is poised to lead that catchup effort and other FDA initiatives following nomination by President Obama for FDA commissioner, a nomination the U.S. Senate is expected to confirm. Dr. Califf joined FDA after 33 years with Duke University School of Medicine and the Duke University Medical Center, most notably vice chancellor of clinical and translational research and, in 2006, founder of the Duke University Clinical Research Institute.  At Duke, Dr. Califf led several key clinical trials, including the pivotal ROCKET AF study that led to FDA approval of Jansen Pharmaceuticals’ Xarelto® (rivaroxaban) in 2011. With more than 1,200 publications in peer-reviewed journals to his credit, he has been recognized by the Institute for Scientific Information as one of the 10 most-cited medical authors.

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