Biden’s FDA Chief Nominee Narrowly Wins Senate Affirmation

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Feb. 15, 2022 — Robert Califf, MD, on Tuesday narrowly gained Senate affirmation to as soon as once more function the commissioner of the FDA, overcoming protest votes from lawmakers about abortion and opioid points.

The Senate voted 50-46 in favor of Califf’s nomination. A heart specialist lengthy affiliated with Duke College and a famous skilled on medical trials, Califf additionally led the FDA from February 2016 by means of January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At the moment, Sen. Joe Manchin, D-WV, and some different senators mentioned they have been involved Califf’s hyperlinks to the drug business would hamper his capacity to control drugmakers, significantly by way of guidelines on prescription painkillers.

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Manchin additionally objected to Califf’s second nomination as FDA commissioner, as did a number of fellow Democrats, together with Sen. Edward Markey of Massachusetts. In an announcement issued after the Tuesday vote, Markey mentioned he has “constantly raised considerations concerning the FDA’s egregious mishandling of opioid approvals and its position in enabling the present opioid epidemic.”

“So far, the FDA nonetheless has not applied lots of the reforms crucial to make sure that it’s fulfilling its position as our nation’s prime pharmaceutical cop on the beat,” Markey mentioned. “I’ve not acquired any actual dedication from Dr. Califf to actually reform the FDA or to study from the failures that fueled this public well being disaster.”

This time, Califf misplaced help amongst Republican senators because of objections raised by teams searching for to finish ladies’s entry to abortion. Susan B. Anthony Checklist and Nationwide Proper to Life requested senators in a January letter to oppose Califf’s nomination, citing their objections to how the FDA dealt with reporting of adversarial occasions from abortions by remedy throughout Califf’s tenure.

However some Republicans supported Califf within the Tuesday vote. Sens. Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania all voted in his favor

On Monday, Sen. Patty Murray, D-WA, chairwoman of the Senate Well being, Training, Labor and Pensions Committee, urged her colleagues to vote for Califf to offer the FDA sturdy management to deal with pressing well being wants such because the opioid disaster, youth tobacco use, antimicrobial resistance, and inequities in well being care.

“At this crucial second, we’d like a trusted hand to steer the FDA,” she mentioned in a flooring speech. Califf’s earlier service on the FDA and his years spent as a analysis scientist “give him the expertise to tackle this problem.”

Individually, three former FDA commissioners on Tuesday revealed an opinion article that appeared inThe Hill. Republican presidents nominated two of those former FDA chiefs: Scott Gottlieb, MD, and Mark McClellan, MD. The third, Margaret Hamburg, MD, was nominated by President Barack Obama, as was Califf for his first time as FDA chief.

There’s an pressing want for a confirmed chief on the FDA because the U.S. seeks to maneuver past the pandemic, the previous FDA chiefs wrote. The work forward contains continued efforts with vaccines in addition to efforts to bolster medical provide chains, they mentioned.

Califf “is aware of the best way to advance the secure growth and use of medical merchandise and to carry a sound, science-based basis to the FDA’s regulatory actions. Due to this, he has earned the arrogance of FDA’s skilled profession workers, in addition to a broad base of affected person teams, educational specialists, medical professionals and public well being organizations,” Gottlieb, Hamburg, and McClellan wrote.

The article additionally was signed by former Facilities for Medicare and abortion Companies Administrator Andy Slavitt, who served within the Obama administration.

Assist of Medical Neighborhood

The American Coronary heart Affiliation on Tuesday issued an announcement congratulating Califf on his second affirmation after the Senate vote.

“With a distinguished profession in public service and a long-time volunteer chief on the American Coronary heart Affiliation, Dr. Califf has honed his capacity to speak and construct belief with numerous constituencies,” CEO Nancy Brown mentioned within the assertion. “He’ll use his expertise as a heart specialist to safeguard the well being and well-being of individuals all through the nation, and his background in analysis to prioritize science and evidence-based policymaking.”

Califf was additionally backed by the Affiliation of American Medical Faculties, American Academy of Pediatrics, American Academy of Household Physicians, and American Faculty of Physicians when he was nominated for the position final 12 months by President Joe Biden.

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