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Robert Califf moves a step closer to FDA leadership

US Senate committee backs his nomination to serve as the regulator's commissioner
FDA

Robert Califf has passed another hurdle on his way to take up the top job at the US FDA, with the US Senate's Health, Education, Labor and Pensions (HELP) Committee voting in his favour this week.

Califf still has to pass a full Senate vote, but is now firmly on course to replace former FDA commissioner Margaret Hamburg, who resigned from the post last March.

A cardiologist and medical researcher, he joined the FDA in January 2015 as deputy commissioner for medical products and tobacco and was nominated for the commissioner role by President Barack Obama shortly after Hamburg announced her departure.

From the outset of joining the agency Califf has been tipped as a possible successor to Hamburg and prior to joining the regulator he served as a member of the FDA Cardio-renal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology, so has long-standing links with the agency.

His elevation to commissioner is not without opponents, however. Democratic presidential candidate Bernie Sanders was not at the HELP committee meeting at which the vote was taken, but said he would have voted against Califf's nomination because he considers him to have too many ties to the pharmaceutical industry.

Sanders said Califf's "extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans."

Much of the concern on that front stems from Califf's leadership of the Duke University Clinical Research Institute, a contract research organisation (CRO) that has worked with many of the top pharma companies. For his part, Califf has insisted this work was all done to the highest standards and in line with guidelines on data access.

Meanwhile, Republican Senator Lisa Murkowski voted in favour of Califf in the HELP committee but has threatened to block the Senate vote on Califf's accession. That is a political manoeuvre however as she is lobbying for the FDA to implement mandatory labelling of products made from genetically-modified salmon. Salmon is a key industry in Murkowski's home state of Alaska.

Otherwise Califf seems to have broad support however, and HELP committee chair Lamar Alexander tweeted after the vote: "I have concluded that Dr Califf is the right person to lead the FDA, and I plan to support him for commissioner."

Article by
Phil Taylor

14th January 2016

From: Regulatory

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