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Regulatory News | 15 September 2015 | By Zachary Brennan
President Barack Obama has nominated Robert Califf, the current deputy commissioner for medical products and tobacco at the US Food and Drug Administration (FDA), as the next commissioner of the agency.
Califf joined the FDA back in February following a stint as vice chancellor of clinical and translational research at Duke University. Other prominent roles during his tenure at Duke include director of the Duke Translational Medicine Institute (DTMI), and professor of medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. Before serving as director of DTMI, he was the founding director of the Duke Clinical Research Institute, the world’s largest academic research organization.
In addition to his academic background, Califf's ties to industry have always been close. He previously disclosed that his salary is contractually underwritten in part by several large pharmaceutical companies, including Bristol-Myers Squibb, Eli Lilly and Novartis, according to his 2014 conflict of interest disclosure.
Califf had previously been considered for the role of FDA commissioner on two separate occasions.
The expected nomination comes after Margaret Hamburg resigned as commissioner in March after six years in the position. Hamburg was the sixth-longest serving FDA commissioner in history, the longest-serving (and only the second) female commissioner in the agency's history, and the second-longest-serving commissioner of FDA's modern regulatory era. Stephen Ostroff, previously the FDA's chief scientist, has served as acting commissioner in recent months.
Califf's entrance as FDA commission would come as the Senate is working on its version of legilslation (already passed by the House) that would expedite the processes FDA uses to approve most drugs. The legislation could have a massive impact on the way in which FDA regulates almost every medical product it oversees.
In addition, the agency is preparing to enter into negotiations with the pharmaceutical and medical device industries regarding user fees. Under various pieces of legislation—the Prescription Drug Use Fee Act, the Medical Device User Fee Act, the Generic Drug User Fee Act and the Biosimilar User Fee Act—FDA collects fees from pharmaceutical and medical device companies to help it hire more staff and review new product applications more quickly. In return for that money, FDA is supposed to adhere to specific timelines for reviewing products.
Tags: Robert Califf, FDA, Margaret Hamburg, FDA Commissioner