Senate vote removes major hurdle in Robert Califf’s bid to lead FDA
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WASHINGTON — Dr. Robert Califf moved one step closer to becoming the next chief of the Food and Drug Administration Monday after the Senate voted overwhelmingly to end debate on his nomination, eliminating the threat from a small group of senators who tried to block him.

The vote was 80 to 6, giving Califf the support of far more than the 60 senators he needed to end his opponents’ ability to filibuster his nomination.

The move sets up Califf for a final vote confirming him as the next FDA chief, which could come as soon as Tuesday, but could be delayed as some senators have threatened to give extended speeches on the Senate floor about why they oppose him.

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The opponents, led by Democratic Senators Edward Markey of Massachusetts and Joe Manchin of West Virginia, plan to hit him over his ties to the pharmaceutical industry and what they consider a poor FDA response to the opioid epidemic.

Under Senate rules, Califf’s opponents can fill up as much as 30 hours of debate time before the final vote, which is now virtually certain to make him official as the new head of the FDA.

In remarks just before the vote, Tennessee Senator Lamar Alexander, a Republican and chairman of the Committee on Health, Education, Labor and Pensions, called Califf “the right person for this job,” saying he had been vetted extensively and knows how to tackle issues like helping the FDA keep pace with medical innovation and speed the approval of low-cost generic drugs.

Alexander also noted that the FDA has been without a permanent chief for nearly a year. Margaret A. Hamburg, the previous FDA commissioner, left the top job in March.

And Senator Patty Murray of Washington, the top Democrat on the committee, said she was “confident that Dr. Califf would contribute leadership and expertise” to all of the agency’s challenges and would bring to the role “a record of advancing medical breakthroughs on challenging illnesses.”

Markey, however, said he and the other opponents would keep pushing for tougher FDA policies against opioids.

“We intend to continue this battle through the entire confirmation process,” Markey said in a Senate floor speech. “FDA has to be the cop on the beat, it has to understand their responsibility not to now allow these drugs into our society, and we have to begin the battle now. It’s not directed personally at Dr. Califf, but directed at an agency which has allowed this flood of drugs into our society.”

In addition to Markey and Manchin, the senators who voted against Califf were Richard Blumenthal of Connecticut and Bill Nelson of Florida, both Democrats, and Kelly Ayotte of New Hampshire and Rob Portman of Ohio, both Republicans.

Califf, a cardiologist, joined the FDA as a deputy commissioner in February 2015 after working on his own clinical research and in leadership roles at Duke University.

It was these years at Duke, where he oversaw research that was often funded by drug companies, that led critics to charge that Califf is too close to industry to be an objective FDA leader.

Some of his critics, among them Democratic Senator Elizabeth Warren of Massachusetts, backed down and agreed to support him after Califf provided more details about his Duke years and made assurances of his independence from industry.

And Republican Senator Lisa Murkowski of Alaska, who opposed Califf’s nomination because she objected to the FDA’s policy on the labeling of genetically modified salmon, dropped her opposition when the FDA revamped its policy.

But some opponents remain. Markey and Manchin, along with Blumenthal and Ayotte, believe Califf won’t push the FDA hard enough to act against the nation’s opioid epidemic. And Democratic Senator Bernie Sanders of Vermont, who’s currently out on the presidential campaign trail, has repeatedly said Califf’s close drug company ties render him unacceptable.

At a press conference Monday, Markey and Manchin pleaded for the FDA to crack down on pharmaceutical companies, whom they say have hooked thousands of people on painkillers.

Many of those eventually become addicted to heroin. Markey said more than 40,000 people a year die from opioid use, although others say the figure is closer to 30,000.

Both senators said that Califf’s experience in the industry makes him the wrong man to oversee such a policy change.

“Dr. Califf is a good man, an honorable man,” said Manchin, “But I told Dr. Califf it would be culturally hard for him to change.”

Markey said they planned to continue their push to change the agency’s opioid policy, and that, even if Califf was confirmed, they would try to push Congress to attach strings to the FDA’s funding next year to require stronger measures against opioid abuse and related heroin use.

The pair planned to spend as much of the remaining 30 hours of debate time to talk about the issue. They are planning to read letters from constituents who have suffered under the opioid addiction crisis.

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