Dr. Robert Califf, a well-known cardiologist and researcher from Duke University, has been nominated by President Barack Obama to be the new head of the U.S. Food and Drug Administration.
The Tuesday announcement did not come as a complete surprise, as Califf joined the agency earlier this year as a deputy commissioner under acting commissioner Stephen Ostroff, the Washington Post reported. Ostroff, who had been the FDA's chief scientist, temporarily took over the reins of the agency after former FDA Commissioner Margaret Hamburg resigned last spring, the newspaper said.
While at Duke University, Califf led scores of pivotal clinical trials and served on various FDA advisory committees, the Post reported.
Should the U.S. Senate confirm Califf as the new FDA commissioner, he will take over an agency that is tackling new responsibilities and significant changes.
During Hamburg's tenure, legislation was passed to overhaul the U.S. food safety system and to let the FDA begin regulating tobacco products for the first time. A raft of new drugs were also approved during her six-year tenure, the newspaper reported.
In addition to implementing the extensive food safety legislation passed by Congress in late 2010, the agency is still grappling with how to regulate cigarettes and other tobacco-related products, including cigars and e-cigarettes, the newspaper reported.
Last but not least, new legislation that could accelerate the drug and medical device approval process is winding its way through Congress. Some experts are concerned that the bill could push the FDA to place speed over safety and effectiveness, the Post said.
