United States President Barack Obama has formally announced the nomination of prominent cardiologist and researcher Robert Califf as the next commissioner of the U.S. Food and Drug Administration (FDA).
According to a press release from the White House, Califf is currently the FDA's Deputy Commissioner for Medical Products and Tobacco, a position he has held since March. Prior to joining FDA, Califf had been with his alma mater, Duke University, since 1982, serving as a professor and vice chancellor at Duke University School of Medicine, and as director of the Duke Translational Medicine Institute. Dr. Califf also has served as an advisor on the Institute of Medicine of the National Academies (IOM) and as a member of several FDA advisory committees.
The Wall Street Journal (WSJ) reports that it was widely expected that Califf would become the next FDA commissioner when he joined the agency as deputy commissioner in February, and he was considered once before for the top job.
If confirmed by the U.S. Senate, Califf will replace Stephen Ostroff, previously FDA's chief scientist, who has served as acting commissioner since Margaret Hamburg resigned as commissioner in March after six years at the helm. Califf's nomination by the Senate is not expected to be contentious.
“Unless they’re looking for a reason to slow this down to score points, he should get relatively quick approval,” one unnamed federal official, who deals frequently with Congress, told the WSJ.
Califf' strong reputation as a medical researcher and as author of landmark clinical studies makes this “a fantastic nomination," according to a former colleague.
“I hope that Congress will respond quickly,” said Francis Collins, director of the National Institutes of Health (NIH), to the WSJ. “He has such a wealth of experience in how to do research.”
At least one health advocacy group threw its support behind Califf's nomination.
"[He] has been a leader on so many vital issues that directly impact patient's lives. He will bring a truly important and unique perspective," stated Ellen Sigal, chair of the non-profit Friends of Cancer Research, reports the Washington Post.
"This is a very important choice at this time to carry out the mission of an agency that keeps the country safe and gets new therapies to those that need them most," Sigal said.
Hamburg's tenure as commissioner was characterized by close collaboration with pharmaceutical companies and medical device manufacturers to push more products to market faster. Califf may go in a similar direction — specifically in opening up clinical trial data to support approvals — according to some senior FDA officials, but it is still uncertain where Califf intends to take the agency, reports the WSJ.
"He has a been a big proponent of figuring out how to conduct clinical trials more inexpensively by collecting less data per patient, perhaps by using electronic medical records systems," reports Forbes.
The medtech industry will be watching closely to see how Califf, as FDA commissioner, will contend with new legislation, particularly the 21st Century Cures Act, that seeks to forgo clinical trials in favor of other sources, such as patient case histories.
Proponents of such legislation say regulatory changes that speed approvals foster innovation and get products to patients more quickly. However, critics argue that relaxing requirements only compromises patient safety.