Biden’s FDA Chief Nominee Narrowly Wins Senate Confirmation

Biden’s FDA Chief Nominee Narrowly Wins Senate Affirmation

Robert Califf, MD, on Tuesday narrowly received Senate affirmation to as soon as once more function the commissioner of the US Meals and Drug Administration (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 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 have been involved Califf’s hyperlinks to the drug business would hamper his potential to control drugmakers, significantly by way of 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 an announcement issued after the Tuesday vote, Markey stated he has “persistently raised considerations concerning 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 applied lots of the reforms obligatory to make sure that it’s fulfilling its function as our nation’s prime pharmaceutical cop on the beat,” Markey stated. “I’ve not obtained any actual dedication from Dr. Califf to really reform the FDA or to be taught from the failures that fueled this public well being disaster.”

This time, Califf misplaced assist amongst Republican senators on account of objections raised by teams looking 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 hostile 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 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 healthcare.

“At this essential second, we want a trusted hand to guide the FDA,” she stated 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 printed an opinion article that appeared in The 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 as the US 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 stated.

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

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

Help of Medical Group

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 potential to speak and construct belief with various 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 Affiliation of American Medical Faculties, the American Academy of Pediatrics, the American Academy of Household Physicians, and the American School of Physicians when he was nominated for the function final 12 months by President Joe Biden.

Sources

United States Senate: “Roll Name Vote 117th Congress — 2nd Session, Query: On the Nomination (Affirmation: Robert McKinnon Califf, of North Carolina, to be Commissioner of Meals and Medicine, Division of Well being and Human Companies).”

Congress.gov: “PN849 — Robert McKinnon Califf — Division of Well being and Human Companies.”

Medscape: “Califf Plans Work on Opioids, Accelerated Approvals on Return to FDA.”

Letter to U.S. senators, Susan B. Anthony Checklist.

The Hill: “America wants a confirmed chief at FDA — now.”

Affiliation of American Medical Faculties: “AAMC Assertion on the Nomination of Robert M. Califf, MD as FDA Commissioner.”

American Academy of Household Physicians, American Academy of Pediatrics, and American School of Physicians: “Joint Letter to Congress Supporting Robert Califf’s Nomination for FDA Commissioner — December 10, 2021.”

Kerry Dooley Younger is a contract journalist based mostly in Miami Seashore, Florida. She is the core subject chief on affected person issues of safety for the Affiliation of Well being Care Journalists. Younger earlier coated well being coverage and the federal price range for Congressional Quarterly/CQ Roll Name and the pharmaceutical business and the Meals and Drug Administration for Bloomberg. Observe her on Twitter at @kdooleyyoung.

For extra information, observe Medscape on Fb, Twitter, Instagram, YouTube, and LinkedIn.

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