(Reuters) — The FDA today named Dr. Robert Califf, a cardiologist and researcher, to oversee its drug, medical device and tobacco policy, in what experts said is a coup for the FDA.
Califf was named as deputy commissioner for medical & and tobacco, the most senior medical products position at the agency after the commissioner and 1 that has been empty for nearly 2 years.
"This is a great catch for the FDA," said Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. "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."
Califf, who will take up his position at the end of February, is currently vice chancellor of clinical and translational research at Duke University, a field focused on translating scientific advances into medical care.
He has run countless clinical studies, served on FDA advisory committees, and was rumored in 2009 to be a potential FDA commissioner before the job went to the current commissioner, Dr. Margaret Hamburg. His new appointment raises the prospect of his becoming the next FDA commissioner.
"He is a guy who could very easily be FDA commissioner under any administration," said Peter Pitts, a former associate director for external relations at the FDA and president of the Center for Medicine in the Public Interest. "He is 1 of the few candidates who could sail through the confirmation process because of his universally recognized talents."
Califf said in a statement that he was "delighted" to accept the appointment, which comes as the FDA faces a sea of challenges.
Among them: How to ensure drug safety when many products are sourced overseas. How tightly should the agency regulate electronic cigarettes? How can it speed development of new therapeutics? How should it regulate copies of biologic drugs, known as biosimilars?
Califf has close ties with the drug industry, having worked on myriad high-profile clinical studies, and he is also close with Dr. Janet Woodcock, the FDA’s powerful head of pharmaceuticals, people familiar with the 2 say. Woodcock was not immediately available to comment.
A spokeswoman for the Pharmaceutical Research & Manufacturers of America, which represents drug companies, did not immediately respond to a request for comment. Pitts said Califf is "respected" by industry.