The White House announced Tuesday that President Obama has nominated Robert Califf, M.D., to be the next commissioner of the U.S. Food and Drug Administration, Califf, 63, is currently FDA’s Deputy Commissioner for Medical Products and Tobacco. If confirmed by the U.S. Senate, Califf will replace Dr. Margaret Hamburg, who resigned earlier this year after nearly six years as FDA Commissioner to take a job with the Institute of Medicine as its foreign secretary. In the interim, FDA’s acting commissioner has been Stephen Ostroff, M.D.

Califf joined FDA in February of this year after 30 years with Duke University in Durham, NC, as a cardiologist, medical professor and researcher. He is a graduate of Duke’s School of Medicine. Reports are that Califf had previously been considered for the commissioner’s post and that his nomination came as no surprise. “Dr. Califf has had a long and distinguished research career, and is internationally known for his expertise in clinical trials,” said Dr. Aaron Kesselheim of Harvard Medical School. “He’s thoughtful and personable, and I’m sure will be a strong advocate on behalf of the FDA during a very critical period.” “Califf is in a sense the ultimate insider for the job, having been groomed for this position since the George W. Bush administration,” said Daniel Carpenter, Harvard University professor of government. “Many will worry that, unlike many past commissioners — including his predecessor — he has little public health experience.” As FDA Commissioner, Califf will likely face many unfinished projects and potential challenges, including pending tobacco regulations, food safety and labeling reforms, and proposals from members of Congress intent on streamlining drug reviews. Another major portfolio item will be finalizing rules for the Food Safety Modernization Act (FSMA), the sweeping food safety reform legislation Obama signed in 2011 but which has yet to see full implementation. The president requested, and FDA’s leadership has been advocating, significant additional funding for that purpose, but congressional budget action has so far lagged behind what the agency says it needs.

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