Dr. Califf nominated by president to lead the FDA

Dr. Robert Califf

Dr. Robert Califf, who was seen as former FDA Commissioner Margaret Hamburg's pick to replace her when she brought him into the agency a month ahead of her departure, may now get the job for keeps. He was nominated Tuesday by President Barack Obama to be commissioner of the FDA.

A cardiologist, Califf has been serving as FDA Deputy Commissioner for Medical Products and Tobacco. But he is very experienced and well known in the pharmaceutical industry, having conducted clinical research as the founding director of in-house CRO Duke Clinical Research Institute. Among many others, he led the 6-year IMPROVE-IT study, from which the positive outcomes of Merck's ($MRK) Zetia paved the way for approval of PCSK9 inhibitors.

Califf is also on the record as believing in collaboration between regulators and industry for effective drug development. He told Time magazine earlier this year that the FDA's role includes both "regulating an industry and creating the conditions where the industry can thrive."

If approved by the Senate, one of the most pressing issues on his plate is the potential approval of the 21st Century Cures Act, which would speed drug approvals. It has industry support but also critics among consumer advocates who see it as undermining drug safety in the country.

But pharma is only one part of a commissioner's responsibilities. The Washington Post points out the agency is still implementing an overhaul of its approach to food safety, as well as feeling its way through oversight of tobacco, not to mention new products like vapor cigarettes.

A spokesman for PhRMA, the Washington, DC-based industry group, declined to comment on the nomination, standard policy for the association, but pointed out PhRMA is on record supporting a full-time commissioner.

President Barack Obama

That will be his next test. Given that many of President Obama's nominations have been entangled by the partisan politics of the day, Califf's approval is not assured. Still, Republicans and Democrats seem to find ways to work together when it comes to the FDA, having approved additional funding for it when other parts of the government have had to make due with less. In fact, Califf has twice before been considered for the top role at the FDA, having been interviewed once by the administration of the last President George Bush and by Obama's team before Hamburg was selected.

When he first came into the agency, one FDA veteran noted that Califf has the kind of background that should allow him to run the nominating gauntlet relatively unscathed. "He is one of the few candidates who could sail through the confirmation process because of his universally recognized talents," Peter Pitts said when Califf was named to his new role.

- here's the White House release
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