Political News

Biden considering Duke doc Robert Califf, to lead FDA

Posted October 14, 2021 3:44 p.m. EDT
Updated October 15, 2021 8:53 a.m. EDT

WASHINGTON — The White House is considering nominating Dr. Robert M. Califf, a former Food and Drug Administration commissioner, to once again lead the agency, according to five people familiar with the search for a candidate.

The FDA has been without a permanent chief since President Joe Biden took office, leading to frequent criticism from public health experts who have said the agency has lacked clear direction during an intense phase of the pandemic, while it has faced a crush of reviews of coronavirus vaccines, tests and treatments.

The people familiar with the search process said that no final decision had been made. The acting FDA commissioner, Dr. Janet Woodcock, a longtime drug regulator, is nearing the end of the term that acting officials are allowed to serve.

Califf declined to comment. News of his possible nomination was first reported by The Washington Post.

Califf, a cardiologist who teaches at the Duke University School of Medicine, served only briefly as FDA commissioner, at the end of President Barack Obama’s second term. He was the agency’s deputy commissioner for medical products and tobacco before leading it from February 2016 to January 2017.

He was confirmed by the Senate as commissioner in February 2016 in a 89-4 vote, after some lawmakers opposed his nomination over what they said was the agency’s poor record on prescription painkillers. His nomination faced its fiercest pushback from Democrats.

One senior federal official familiar with the administration’s search said that Califf was an appealing candidate to the White House because of his prior confirmation as agency commissioner, suggesting that he could make it through the Senate confirmation process again. Several key Democrats have signaled that they would not support Woodcock, who has been at the FDA since 1986, if she were nominated as the agency’s permanent commissioner.

Sen. Joe Manchin, D-W.Va., who is a key moderate vote, wrote a letter in June to Biden criticizing Woodcock’s record at the FDA, saying that she had not challenged the agency’s approval of opioid painkillers earlier in her career.

“While industry has benefited from the status quo over the last 35 years of Dr. Woodcock’s tenure at the FDA,” he wrote, “the people, patients and families suffering from the opioid epidemic have not.”

Woodcock is admired by some leaders within the FDA. But her tenure as acting commissioner has at times come under withering criticism. Earlier this year, the agency granted approval of aducanumab, a new medication for Alzheimer’s disease, a controversial decision that was opposed by the agency’s independent advisory panel and many outside scientists. Several members of the panel quit in protest. The FDA later called for a federal investigation of the process that led to the approval.

The agency has said that Woodcock was not involved in the deliberations and left the final ruling to the head of the center responsible for drug applications.

Woodcock has also faced something of an internal revolt this year in the agency’s vaccines office, one of its key divisions. The two leaders of that office are set to leave the agency this fall; several people who heard about their decision said they were departing partly out of frustration with the Biden administration’s August announcement that it was planning for a broad rollout of booster shots for coronavirus vaccine recipients.

Public health experts criticized the administration for preempting the FDA and the Centers for Disease Control and Prevention, which had yet to conduct reviews of the shots. Woodcock signed the statement announcing the plan, a move that critics said undermined her own regulators. This article originally appeared in The New York Times.

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