Califf wins Senate approval as new chief at FDA

By Daniel Enoch

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WASHINGTON, Feb. 24, 2016 - Dr. Robert Califf, a prominent cardiologist who spent more than three decades as a medical researcher at Duke University, was overwhelmingly confirmed by the Senate Wednesday as the new commissioner of the Food and Drug Administration. The vote was 89-4.

Califf was nominated by President Barack Obama in September, but a small group of lawmakers delayed consideration of the nomination over concerns about the FDA's recent approval of genetically engineered salmon for use as food and the agency's handling of the ongoing opioid abuse crisis.

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Four senators, including Democrats Edward Markey of Massachusetts and Joe Manchin of West Virginia, opposed Califf's nomination, blasting the FDA during hearings for what they said was a lax approach to dealing with opoid abuse. Bernie Sanders, the Vermont Independent who is running for president, also opposed the nomination but did not leave the campaign trail for the vote.

As the new boss at FDA, Califf has a full slate of tasks ahead of him, including finishing up tobacco regulations and continuing to implement the most sweeping reform of the nation's food safety laws in more than 70 years - the Food Safety Modernization Act (FSMA).

Califf also promised earlier this month to add new warning labels to some of the more widely used painkillers and to consult more often with outside advisers on the medications.

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"I believe Dr. Califf understands the dire nature of the opioid epidemic and, accordingly, I believe he is today the right person to lead the FDA in a new direction," Senate Majority Leader Mitch McConnell, R-Ky., said this week.

Califf joined the FDA as a deputy commissioner a year ago after holding senior positions at Duke University, where in 2006 he founded a clinical research institute that receives much of its funding from the drug industry. Califf has said his research was never influenced by the funding.

Dr. Stephen Ostroff, the FDA's chief scientist, has been serving as acting head of the agency since early last year when Dr. Margaret Hamburg left after six years as commissioner.

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