Biden’s FDA Lead Candidate Narrowly Wins Senate Confirmation

February 15, 2022 — Robert Califf, MD, narrowly won Senate confirmation on Tuesday to serve as FDA commissioner again, beating protest votes from lawmakers on abortion and opioid issues.

The Senate voted 50-46 to appoint Califf. Califf is a longtime Duke University cardiologist and a noted expert on clinical trials. Califf also headed the FDA from February 2016 to January 2017.

In 2016, the Senate confirmed him as FDA chief in a vote of 89-4. At the time, Senator Joe Manchin, D-WV and a few other senators said they were concerned that Califf’s ties to the drug industry would hamper its ability to regulate drugmakers, particularly over prescription painkiller regulations.

Manchin also objected to Califf’s second appointment as FDA commissioner, as did several fellow Democrats, including Massachusetts Senator Edward Markey. In a statement released after Tuesday’s vote, Markey said he has “consistently expressed concern about the FDA’s blatant mishandling of opioid approvals and its role in enabling the current opioid epidemic.”

“To date, the FDA still hasn’t made many of the reforms needed to ensure it is fulfilling its role as our nation’s top pharmaceutical agent to measure,” said Markey. “I’ve had no real commitment from Dr. Califf to really reform the FDA or learn from the failures that fueled this public health crisis.”

This time, Califf lost the support of Republican senators over objections from groups seeking to end women’s access to abortion. Susan B. Anthony List and National Right to Life asked senators in a January letter to oppose Califf’s nomination, citing their objections to the FDA’s reporting of drug abortion side effects during his tenure. Califf treated.

But some Republicans supported Califf in Tuesday’s 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, Senator Patty Murray, D-WA, chair of the Senate Committee on Health, Education, Labor and Pensions, urged her colleagues to vote for Califf to give the FDA strong leadership to address pressing health needs, such as the opioid crisis, youth tobacco use, antimicrobial resistance and health inequalities.

“At this critical juncture, we need a trusted hand to guide the FDA,” she said in a speech on the floor. Califf’s previous service with the FDA and his years as a research scientist “give him the experience to meet this challenge.”

Separately, three former FDA commissioners published an opinion article on Tuesday that appeared in The Hill. Republican presidents nominated two of these 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 is an urgent need for a confirmed leader at the FDA as the US tries to move past the pandemic, the former FDA chiefs wrote. The work ahead includes ongoing efforts with vaccines and efforts to strengthen medical supply chains, they said.

Califf “knows how to promote the safe development and use of medical products and build a sound, science-based foundation for FDA’s regulatory actions. This has earned him the trust of the FDA’s professional career staff, as well as a broad base of patient groups, academic experts, medical professionals and public health organizations,” wrote Gottlieb, Hamburg and McClellan.

The article was also signed by Andy Slavitt, former administrator of the Centers for Medicare and Abortion Services, who served in the Obama administration.

Supporting the medical community

The American Heart Association released a statement Tuesday congratulating Califf on his second confirmation after the Senate vote.

“With a distinguished career in public service and a longtime volunteer leader with the American Heart Association, Dr. Califf has honed his ability to communicate and build trust with various constituencies,” CEO Nancy Brown said in the statement. “He will use his experience as a cardiologist to protect the health and well-being of people across the country, and his background in research to prioritize science and evidence-based policy making.”

Califf was also supported 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 role by President Joe Biden last year.

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