Dr. Califf had been named the FDA’s deputy commissioner for medical products and tobacco-effectively the No. 2 post-in February. Before that, he was founding director of Duke’s Clinical Research Institute, the world’s largest academic research organization, the FDA said.
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He is a well-known figure in medicine, distinguished by a leadership role in a wide range of clinical studies.
But Califf’s work for drugmakers could also complicate his path to confirmation, particularly among Senate lawmakers who say the FDA is already too cozy with the industry.
Reports are that Califf had previously been considered for the commissioner’s post and that his nomination came as no surprise.
If confirmed, Califf will replace Stephen Ostroff, who has served as acting commissioner since former commissioner Margaret Hamburg left the position in March.
President Obama nominated Robert Califf, a prominent cardiologist and longtime researcher at Duke University, as the next commissioner of the Food and Drug Administration on Tuesday.
Hamburg served as health commissioner of New York City before her six years leading the FDA. “He has such a wealth of experience in how to do research”.
But according to the Wall Street Journal, Diana Zuckerman, president of medical product safety group the National Center for Health Research, has also questioned Califf’s ties to the drug industry.
He could face some heated Senate queries over his close ties to pharmaceutical companies. He led the key clinical trial evaluating Johnson & Johnson’s blood-thinner Xarelto, which the FDA approved in 2011 to prevent strokes in people with an irregular heartbeat.
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As head of the FDA, Califf would inherit a raft of projects and potential challenges, including unfinished tobacco regulations, food safety and labeling reforms and proposals from Republican lawmakers focused on streamlining drug reviews.
