WASHINGTON — The White House is contemplating nominating Dr. Robert M. Califf, a former Food and Drug Administration commissioner, to as soon as once more lead the company, in accordance to 5 folks acquainted with the seek for a candidate.
The F.D.A. has been with out a everlasting chief since President Biden took workplace, main to frequent criticism from public well being specialists who’ve mentioned the company has lacked clear path throughout an intense section of the pandemic, whereas it has confronted a crush of critiques of coronavirus vaccines, exams and coverings.
The folks acquainted with the search course of mentioned that no remaining resolution had been made. The performing F.D.A. commissioner, Dr. Janet Woodcock, a longtime drug regulator, is nearing the tip of the time period that performing officers are allowed to serve.
Dr. Califf declined to remark. News of his doable nomination was first reported by The Washington Post.
Dr. Califf, a heart specialist who teaches on the Duke University School of Medicine, served solely briefly as F.D.A. commissioner, on the finish of President Barack Obama’s second time period. He was the company’s deputy commissioner for medical merchandise and tobacco earlier than main it from February 2016 to January 2017.
He was confirmed by the Senate as commissioner in February 2016 in a vote of 89 to 4, after some lawmakers opposed his nomination over what they mentioned was the company’s poor document on prescription painkillers. His nomination confronted its fiercest pushback from Democrats.
One senior federal official acquainted with the administration’s search mentioned that Dr. Califf was an interesting candidate to the White House due to his prior affirmation as company commissioner, suggesting that he might make it by the Senate affirmation course of once more. Several key Democrats have signaled that they might not assist Dr. Woodcock, who has been on the F.D.A. since 1986, if she had been nominated because the company’s everlasting commissioner.
Senator Joe Manchin, a West Virginia Democrat who’s a key reasonable vote, wrote a letter in June to Mr. Biden criticizing Dr. Woodcock’s document on the F.D.A., saying that she had not challenged the company’s approval of opioid painkillers earlier in her profession.
“While industry has benefited from the status quo over the last 35 years of Dr. Woodcock’s tenure at the F.D.A.,” he wrote, “the people, patients and families suffering from the opioid epidemic have not.”
Dr. Woodcock is admired by some leaders inside the F.D.A. But her tenure as performing commissioner has at occasions come below withering criticism. Earlier this 12 months, the company granted approval of aducanumab, a new remedy for Alzheimer’s illness, a controversial resolution that was opposed by the company’s impartial advisory panel and plenty of exterior scientists. Several members of the panel stop in protest. The F.D.A. itself later known as for a federal investigation of the method that led to the approval.
The company has mentioned that Dr. Woodcock was not concerned within the deliberations and left the ultimate ruling to the pinnacle of the middle answerable for drug functions.
Dr. Woodcock has additionally confronted one thing of an inner revolt this 12 months within the company’s vaccines workplace, one among its key divisions. The two leaders of that workplace are set to go away the company this fall; a number of individuals who heard about their resolution mentioned they had been departing partly out of frustration with the Biden administration’s August announcement that it was planning for a broad rollout of booster pictures for coronavirus vaccine recipients.
Public well being specialists criticized the administration for pre-empting the F.D.A. and the Centers for Disease Control and Prevention, which had but to conduct critiques of the pictures. Dr. Woodcock signed the assertion asserting the plan, a transfer that critics mentioned undermined her personal regulators.
Katie Rogers, Sharon LaFraniere and Katie Thomas contributed reporting.