Biden’s FDA Chief Nominee Narrowly Wins Senate Confirmation

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 University and a famous skilled on scientific 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 that point, Sen. Joe Manchin, D-WV, and some different senators mentioned they had been involved Califf’s hyperlinks to the drug business would hamper his capability to control drugmakers, notably 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 “consistently raised concerns about the FDA’s egregious mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still has not implemented many of the reforms necessary to ensure that it is fulfilling its role as our nation’s top pharmaceutical cop on the beat,” Markey mentioned. “I have not received any real commitment from Dr. Califf to truly reform the FDA or to learn from the failures that fueled this public health crisis.”

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 List and National Right 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 medicine throughout Califf’s tenure.

But 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 Health, Education, Labor and Pensions Committee, urged her colleagues to vote for Califf to provide the FDA robust management to sort out pressing well being wants such because the opioid disaster, youth tobacco use, antimicrobial resistance, and inequities in well being care.

“At this critical moment, we need a trusted hand to lead 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 experience to take on this challenge.”

Separately, 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 “knows how to advance the safe development and use of medical products and to bring a sound, science-based foundation to the FDA’s regulatory actions. Because of this, he has earned the confidence of FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals and public health organizations,” Gottlieb, Hamburg, and McClellan wrote.

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

Support of Medical Community

The American Heart Association on Tuesday issued a press release congratulating Califf on his second affirmation after the Senate vote.

“With a distinguished career in public service and a long-time volunteer leader at the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with diverse constituencies,” CEO Nancy Brown mentioned within the assertion. “He will use his experience as a cardiologist to safeguard the health and well-being of people throughout the country, and his background in research 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.