Biden's FDA Chief Nominee Narrowly Wins Senate Confirmation

Kerry Dooley Young

February 15, 2022

Robert Califf, MD, on Tuesday narrowly won Senate confirmation to once again serve as the commissioner of the US Food and Drug Administration (FDA), overcoming protest votes from lawmakers about abortion and opioid issues.

The Senate voted 50-46 in favor of Califf's nomination. A cardiologist long affiliated with Duke University and a noted expert on clinical trials, Califf also led the FDA from February 2016 through January 2017.

In 2016, the Senate confirmed him as FDA chief in an 89-4 vote. At that time, Sen. Joe Manchin, D-WV, and a few other senators said they were concerned Califf's links to the drug industry would hamper his ability to regulate drugmakers, particularly in terms of rules on prescription painkillers.

Manchin also objected to Califf's second nomination as FDA commissioner, as did several fellow Democrats, including Sen. Edward Markey of Massachusetts. In a statement issued after the Tuesday vote, Markey said 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 said. "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 lost support among Republican senators due to objections raised by 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 how the FDA handled reporting of adverse events from abortions by medication during Califf's Tenure.

But some Republicans supported Califf in 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 give the FDA strong leadership to tackle urgent health needs such as the opioid crisis, youth tobacco use, antimicrobial resistance, and inequities in healthcare.

"At this critical moment, we need a trusted hand to lead the FDA," she said in a floor speech. Califf's previous service at the FDA and his years spent as a research scientist "give him the experience to take on this challenge."

Separately, three former FDA commissioners on Tuesday published an opinion article 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's an urgent need for a confirmed leader at the FDA as the United States seeks to move beyond the pandemic, the former FDA chiefs wrote. The work ahead includes continued efforts with vaccines as well as efforts to bolster medical supply chains, they said.

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 also was signed by former Centers for Medicare and Medicaid Services Administrator Andy Slavitt, who served in the Obama administration.

Support of Medical Community

The American Heart Association on Tuesday issued a statement congratulating Califf on his second confirmation 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 said in the statement. "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 also backed by the Association of American Medical Colleges, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Physicians when he was nominated for the role last year by President Joe Biden.

Sources

United States Senate: "Roll Call Vote 117th Congress — 2nd Session, Question: On the Nomination (Confirmation: Robert McKinnon Califf, of North Carolina, to be Commissioner of Food and Drugs, Department of Health and Human Services)."

Congress.gov: "PN849 — Robert McKinnon Califf — Department of Health and Human Services."

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

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

The Hill: "America needs a confirmed leader at FDA — now."

Association of American Medical Colleges: "AAMC Statement on the Nomination of Robert M. Califf, MD as FDA Commissioner."

American Academy of Family Physicians, American Academy of Pediatrics, and American College of Physicians: "Joint Letter to Congress Supporting Robert Califf's Nomination for FDA Commissioner — December 10, 2021."

Kerry Dooley Young is a freelance journalist based in Miami Beach, Florida. She is the core topic leader on patient safety issues for the Association of Health Care Journalists. Young earlier covered health policy and the federal budget for Congressional Quarterly/CQ Roll Call and the pharmaceutical industry and the Food and Drug Administration for Bloomberg. Follow her on Twitter at @kdooleyyoung.

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