Duke Researcher Nominated as FDA Chief

President Barack Obama has formally nominated cardiologist and researcher Robert Califf, M.D., to lead the U.S. Food and Drug Administration (FDA).

A White House news release said Califf currently is the FDA’s deputy commissioner for Medical Products and Tobacco, a position he has held since March. Before joining the 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. 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.  

According to the Wall Street Journal (WSJ), it was widely expected that Califf would become the next FDA commissioner when he joined the agency as deputy commissioner in February. 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 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,” gushed a former colleague.

If confirmed by the Senate, Califf would inherit an agency facing broad new responsibilities and potentially on the brink of major changes. The FDA is in the middle of implementing the extensive food safety legislation passed by Congress in late 2010, an effort that has taken years. Likewise, federal regulators are still wrangling with how best to regulate cigarettes and other other tobacco-related products, such as cigars and e-cigarettes.

In addition, new legislation known as the 21st Century Cures Act, which has been working its way through Congress over the past year, could alter the speed and manner in which the FDA approves drugs and medical devices. Advocates have said the bill would help accelerate the agency’s reviews and get needed innovations to patients more quickly, though some experts worry the legislation could force the FDA to compromise its high standards for safety and efficacy in the name of speed.

 

“I hope that Congress will respond quickly,” Francis Collins, director of the National Institutes of Health (NIH), told the WSJ. “He has such a wealth of experience in how to do research.”

Some health groups were quick to welcome Califf’s nomination, saying his background as a respected researcher and clinician makes him a strong candidate for the post. “[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,” Ellen Sigal, chair of the non-profit Friends of Cancer Research, said in a formal statement. “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.”

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,” reported Forbes.

During the course of his career, Califf has faced questions about his close ties to the pharmaceutical industry over the years. A 2014 financial disclosure showed his salary at Duke was underwritten partly by funding from large drug makers such as Eli Lilly, Novartis and Merck, according to the Washington Post. He also reported receiving fees from a range of other pharmaceutical companies.

Califf has declined interview requests since the nomination was announced. But in an interview with Time magazine earlier this year, he said collaborations between academic researchers, the government and the pharmaceutical industry are a necessary, if sometimes uncomfortable, reality of modern drug development.

“The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors,” he told Time, adding that there is “a tension which cannot be avoided between regulating an industry and creating the conditions where the industry can thrive, and the FDA’s got to do both.”