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U.S. FDA names scientist from Duke to senior post

January 27, 2015
Life sciences
 (Reuters) – The U.S. Food and Drug Administration on Monday named Dr. Robert Califf, a top 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 products and tobacco, the most senior medical products position at the agency after the commissioner and one that has been empty for nearly two 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, 63, will take up the position at the end of February. He is currently vice chancellor of clinical and translational research at Duke University, a field focused on translating scientific advances into medical care.
 
Califf has run countless clinical studies, published more than 1,000 papers, served as an FDA adviser and has twice been interviewed as a potential FDA commissioner. His new appointment potentially brings him closer to that position.
 
“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 one of the few candidates who could sail through the confirmation process because of his universally recognized talents.”
 
The appointment 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 new therapeutics? How should it regulate copies of biologic drugs, known as biosimilars?
 
Califf, who has close ties to the drug industry, said on a telephone conference call with reporters that one of his biggest priorities will be to figure out ways to streamline the clinical trial process.
 
He has worked on many high-profile clinical studies, including the IMPROVE-IT study examining the safety and effectiveness of Merck & Co.’s cholesterol drug Zetia. He will step away from any trials with which he is currently involved.
 
The Pharmaceutical Research and Manufacturers of America, which represents drug companies, said in a statement that it “looks forward to working with Dr. Califf on creating an efficient and predictable regulatory system for patients.”
 
Califf will also focus on an initiative being promoted in Congress known as 21st Century Cures that aims to speed new therapies to the market and could shortly result in legislation.
 
He is also close with Dr. Janet Woodcock, the FDA’s powerful head of pharmaceuticals. Woodcock said in an interview that the two go back 20 years to when she was an FDA reviewer and Califf was a clinical trial investigator.
 
“We are extremely fortunate to have him come work with us,” she said.
 
(Reporting by Toni Clarke in Washington; Editing by Leslie Adler)

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