Senate tees up final vote for FDA nominee

President Obama’s choice to run the Food and Drug Administration easily cleared a key Senate procedural hurdle Monday evening and could be confirmed as early as Tuesday.

The Senate voted 80-6 to advance the nomination of Dr. Robert Califf to a final vote, which will be held after 30 hours of debate. Califf needs a simple majority to be confirmed.

Califf received key support from several Republicans, including Sen. Lamar Alexander, R-Tenn. He praised Califf’s work heading Duke University’s medical research branch and his prolific work conducting clinical trials.

“His nomination has been widely applauded,” Alexander said on the Senate floor.

Alexander heads the Senate Health, Education, Labor and Pensions Committee, which advanced the nomination earlier this year.

Sen. Patty Murray of Washington, the committee’s top Democrat, also supported Califf’s nomination.

But he encountered opposition from Democratic Sens. Ed Markey of Massachusetts, Joe Manchin of West Virginia and Richard Blumenthal of Connecticut.

They say the FDA has made the prescription drug abuse epidemic worse by approving too many opioids and are skeptical of Califf’s industry ties.

The senators said they were angry the agency ignored or did not seek expert advice on several occasions.

The two incidents the senators highlighted were the FDA’s 2012 decision to approve powerful painkiller Zohydro without abuse-deterrent technology and to OK a youth-sized version of Oxycontin in 2015 for ages 11-16.

Abuse-deterrent technology can help make drugs harder to chew or snort, common ways to get a quick high.

The FDA approved Zohydro after a panel of experts voted 11-2 to recommend against approval due to questions about the potential for abuse. The agency does not have to abide by the advice of its experts but it usually does.

The incident didn’t sit well with Markey and Manchin, nor did the decision to approve kiddie Oxycontin without getting advice from experts.

“Their slogan from the FDA is no experts need apply,” Markey said on the Senate floor Monday.

The senators are skeptical Califf can change the culture at the FDA because of his extensive industry ties.

“There will be no change in the way that the FDA is responding or failure to respond to the crisis,” Blumenthal said on the Senate floor.

Democratic presidential candidate Sen. Bernie Sanders, I-Vt., also has opposed Califf due to concerns about high drug prices, but did not vote.

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