Dr. Robert Califf, former vice chancellor for clinical and translational research, was appointed deputy commissioner for Medical Products and Tobacco at the FDA in January and will now await Senate approval for the commissioner position after being nominated. Stephen Ostroff has been serving as the interim commissioner since Hamburg’s departure.
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Diana Zuckerman, president of the National Center for Health Research, a Washington-based group focusing on medical- product safety, questioned his ties to the drug industry.
His nomination to head the agency was widely expected after former commissioner Dr. Margaret Hamburg announced she would step down just days after appointing Califf to the role of deputy commissioner.
If confirmed by the Senate – a considerable if, given the many Obama nominations that have languished in recent years – Califf would inherit an agency facing broad new responsibilities and potentially on the brink of major changes.
“His transformative leadership at Duke, and real-world experience with patients make him a remarkable choice that will bring important new perspectives to an already strong agency”, Ellen Sigal, chairwoman of Friends of Cancer Research, said in a statement.
Although he has spent most of his career in academia, Califf is deeply versed in FDA issues, especially the clinical testing of drugs and medical devices.
Through an FDA spokesman, Califf declined an interview request Tuesday. The legislation could have a massive impact on the way in which FDA regulates nearly every medical product it oversees.
A disclosure form filed with Duke University past year shows Califf received research grants or consulting fees from a dozen drugmakers, including Merck & Co., Roche and Eli Lilly & Co.
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A decade ago, Califf founded the Duke Translational Medicine Institute, which has provided money to researchers to develop clinical trials of experimental drugs and to work through the regulatory process.
