dr_robert_califf_image_via_duke_university_school_of_medicine

Senate panel approves Dr Robert Califf as FDA commissioner

pharmafile | January 13, 2016 | Appointment | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Dr Robert Califf, FDA, FDA commissioner, Senate 

A senate panel has approved president Obama’s nominee Dr Robert Califf to lead the FDA by a clear majority, although two senators, including a presidential candidate have threatened to block the appointment.

Dr Califf, a professor of cardiology and medicine at the Duke University’s School of Medicine, received the President’s backing in September. But he has since been criticised over his historic ties to big pharma from his time as a researcher at the university, when he received tens of thousands of dollars in consulting fees from various pharma companies.  

Certain senators believe this would impact on his suitability to lead the FDA, and the strongest criticism came from Republican Lisa Murkowski and Democrat Bernie Sanders, who is in the running to become president this year.

Murkowski said she would block the nomination until the FDA guarantees it will provide written rules for the labelling of genetically modified salmon, while Sanders – who did not attend the meeting – opposes Califf over his perceived lack of ability to stand up to the pharma industry.

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Sanders has previously said: “At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices. Unfortunately, I have come to the conclusion that Dr Califf is not that person.”

Despite this opposition, it now looks highly likely that Califf will go on to lead the Administration. Lamar Alexander, chairman of the senate health committee, said it was important that the vacant commissioner post is filled as soon as possible.

“The FDA affects the lives of nearly every single American and regulates about a quarter of all consumer spending in the United States—over $4 trillion annually,” he comments. “Americans need competent leadership to head this significant agency and to help bring safe drugs and devices to market faster and protect our nation’s food supply. The Senate should consider Dr Califf’s nomination quickly to fill this important role.”

At the prior hearing in November, Alexander said Califf “understand(s) how research gets done in the real world, where there are opportunities for the FDA to help address challenges, and where the FDA needs to get out of the way.”  

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