Biden’s FDA Chief Nominee Narrowly Wins Senate Affirmation

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Feb. 15, 2022 — Robert Califf, MD, on Tuesday narrowly received 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 professional on scientific trials, Califf additionally led the FDA from February 2016 by 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 had been involved Califf’s hyperlinks to the drug trade would hamper his potential to manage drugmakers, significantly when it comes to guidelines on prescription painkillers.

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 a press release issued after the Tuesday vote, Markey mentioned he has “constantly raised considerations in regards to the FDA’s egregious mishandling of opioid approvals and its function in enabling the present opioid epidemic.”

“Up to now, the FDA nonetheless has not carried out most of the reforms mandatory to make sure that it’s fulfilling its function as our nation’s high pharmaceutical cop on the beat,” Markey mentioned. “I’ve not acquired any actual dedication from Dr. Califf to really reform the FDA or to study from the failures that fueled this public well being disaster.”

This time, Califf misplaced assist amongst Republican senators resulting from objections raised by teams searching for to finish ladies’s entry to abortion. Susan B. Anthony Record 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 antagonistic occasions from abortions by treatment 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 provide 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 important second, we want a trusted hand to steer the FDA,” she mentioned in a ground 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 consists of continued efforts with vaccines in addition to efforts to bolster medical provide chains, they mentioned.

Califf “is aware of how one can 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 boldness of FDA’s skilled profession employees, in addition to a broad base of affected person teams, tutorial 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 a press release 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 potential to speak and construct belief with various 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 Schools, American Academy of Pediatrics, American Academy of Household Physicians, and American Faculty of Physicians when he was nominated for the function final 12 months by President Joe Biden.



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