HomeAmericaBiden Considering Robert Califfe, a Former FDA Commissioner, to Lead Agency Again

Biden Considering Robert Califfe, a Former FDA Commissioner, to Lead Agency Again

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

FDA has been without a permanent head Since President Biden took office, there has been constant criticism from public health experts who have said the agency lacks clear direction during an acute phase of the pandemic, while facing reviews of coronavirus vaccines, tests and treatments. Is kept.

People familiar with the search process said that no final decision has been taken yet. The FDA’s acting commissioner, longtime drug regulator, Dr. Janet Woodcock, is nearing the end of the period allowing acting officers to serve.

Dr Califf declined to comment. His possible nomination was first reported by The Washington Post.

Dr. Calif, a cardiologist who teaches at Duke University School of Medicine, only briefly served 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 heading it from February 2016 to January 2017.

He was Confirmed In February 2016, in a vote of 89 to 4 by the Senate as commissioner, after some lawmakers opposed his nomination, he said the agency had a poor record on prescription painkillers. His nomination faced a backlash from the Democrats.

A senior federal official familiar with the administration’s finding said that Dr. Califfe was an attractive candidate for the White House because of his prior confirmation as agency commissioner, suggesting that he should go through the Senate confirmation process again. can make. Several prominent Democrats have indicated they would not support Dr. Woodcock, who has been at the FDA since 1986, if he were named as the agency’s permanent commissioner.

Senator Joe Manchin, a West Virginia Democrat with a major liberal vote, wrote a letter In June, Mr. Biden criticized Dr. Woodcock’s record in the FDA, saying he had not challenged the agency’s approval of opioid painkillers earlier in his career.

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

Dr. Woodcock is admired by some leaders within the FDA but his tenure as acting commissioner has been criticized several times. Earlier this year, the agency approved NS aportanumab, a new drug for Alzheimer’s disease, a controversial decision that was opposed by the agency’s independent advisory panel and many outside scientists. In protest, several members of the panel resigned. FDA itself later called for A federal investigation into the process that led to the approval.

The agency said that Dr. Woodcock was not involved in the deliberations and left the final decision on the head of the center responsible for drug applications.

Dr. Woodcock also faced internal rebellion this year at the agency’s Office of Vaccines, one of its major divisions. there are two leaders in that office ready to go agency this fall; Many who heard about his decision said they were partly out of frustration with the Biden administration’s August announcement that it was planning a wider rollout of booster shots for coronavirus vaccine recipients.

Public health experts criticized the administration for pre-empting the FDA and the Centers for Disease Control and Prevention, which had not yet reviewed the shots. Dr Woodcock signed a statement announcing the plan, a move that critics said undermined its regulators.

Katie Rogers, Sharon Lafreniere And Katie Thomas Contributed reporting.

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