Biden’s FDA Chief Nominee Narrowly Wins Senate Affirmation

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 skilled on clinical 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 stated they had been involved Califf’s links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules 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 stated he has “persistently raised issues concerning the FDA’s egregious mishandling of opioid approvals and its position in enabling the present opioid epidemic.”

“To this point, the FDA nonetheless has not applied lots of the reforms vital to make sure that it’s fulfilling its position as our nation’s high pharmaceutical cop on the beat,” Markey stated. “I’ve not acquired any actual dedication from Dr. Califf to actually reform the FDA or to be taught from the failures that fueled this public well being disaster.”

This time, Califf misplaced help amongst Republican senators as a consequence of objections raised by teams looking 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 handled reporting of adverse events from abortions by medication 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 present the FDA robust 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 essential second, we want a trusted hand to guide the FDA,” she stated 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 consists of continued efforts with vaccines in addition to efforts to bolster medical provide chains, they stated.

Califf “is aware of find out how to advance the protected improvement 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.

Help of Medical Group

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 skill to speak and construct belief with numerous constituencies,” CEO Nancy Brown stated 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 Association of American Medical Colleges, American Academy of Pediatrics, American Academy of Family Physicians, and American College of Physicians when he was nominated for the position final yr by President Joe Biden.

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