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Senate confirms Califf as FDA chief in close vote

On Tuesday, the Senate narrowly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration, a key federal agency that has been without a permanent head for more than a year from the coronavirus pandemic.

The vote was 50 to 46, with six Republicans crossing the aisle in support while five Democrats opposed him. A senator voted present.

Over the past few weeks, Dr. Califf’s chances of a second confirmation looked increasingly long as opposition mounted concerns about how he would respond to the opioid epidemic and the government’s management. agency rules on abortion drugs. The White House responded by trying to rally support from Congress and other allies, with mainstream medical societies and a bipartisan group of six former FDA commissioners coming to Dr. Califf’s defense.

Sen. Richard Burr, a Republican from North Carolina, was among a handful of GOP senators who backed Dr. Califf and offset opposition from some Democrats. On Tuesday, Mr. Burr called on other senators to confirm Dr. Califf, saying the FDA had gone 391 days without a permanent chief.

“I urge my colleagues to support Dr. Califf’s appointment, as he will provide the leadership needed to promote today’s biomedical advances and help pave the way for tomorrow’s innovation,” Burr said.

Despite some Republican support, senators from both parties, ranging from liberal Democrats wary of its ties to the pharmaceutical industry to conservative Republicans in tune with the anti-abortion movement, put up formidable opposition.

By contrast, Dr Califf stepped into the role of commissioner in 2016 in an 89-4 vote, with strong support from both sides of the aisle. Some of the headwinds he has faced since President Biden nominated him in November have come from the same Democratic senators who opposed him six years ago. At the time, Senator Joe Manchin III, Democrat of West Virginia, expressed concern about Dr. Califf’s ties to the pharmaceutical industry amid the opioid epidemic that in 2016 had already killed people. thousands of people.

On Friday, Mr. Manchin called on Mr. Biden to withdraw his nomination in an opinion essay, noting that while Dr. Califf had pledged to make changes the last time he was commissioner, the FDA has approved five new opioids in 2016 and 2017.

“I have never been more deeply confident in a vote that I will cast than right now,” Mr. Manchin said in a fiery speech on Monday, directly blaming part of the blame for the worsening epidemic on the Dr Califf. Opposition to his nomination, Mr. Manchin added, “would send a message to this administration, to our president, that we need new leadership at the FDA.”

“We need people who want to protect us,” he concluded, “not people who allow drugs to destroy us.”

Just before Tuesday’s vote, Sen. Edward Markey, Democrat of Massachusetts, denounced the FDA’s role in becoming the “biggest pill seller in the country” and said Dr. Califf had done little to solve the problem during his previous term as Commissioner.

“There was no real commitment to reforming the FDA or learning from the mistakes that enabled this public health crisis,” Markey said.

Dr. Califf has also come under pressure from abortion haters regarding FDA risk management policies related to abortive drugs. The influential Susan B. Anthony List organization, which opposes abortion, has polled lawmakers about changes made during Dr. Califf’s previous term as commissioner that made access to medical abortion pills easier. .

During a Senate hearing in December, Dr. Califf expressed confidence in the agency’s ability to handle drug decisions again. Two days after that hearing, the FDA announced that women could receive the pills by mail after a telehealth appointment, eliminating the requirement for an in-person assessment.

List Susan B. Anthony has announced that she will ‘score’ the vote on Dr. Califf’s nomination, meaning she will be considered in the organization’s assessments for the ‘pro-life scorecard’ legislators. Republicans seeking re-election often seek group approval.

Senator Steve Daines, Republican of Montana, spoke out in opposition ahead of the vote, criticizing Dr. Califf’s role in changes to abortion drugs.

“Dr. Califf refused to distance himself from the FDA’s decision to abandon vulnerable pregnant women to the reckless and predatory actions of the abortion industry,” Mr. Daines said.

Supporters of Dr. Califf have argued that the agency has long awaited permanent direction, especially as the agency struggles with the review of coronavirus vaccines for young children in addition to other health crises.

“Dr. Califf’s prior service in this role, his career as one of the nation’s leading research scientists, gives him the experience to meet this challenge,” said Senator Patty Murray of Washington, chair of the Senate Committee on Health, Education, Labor and Pensions.

“Having confirmed leadership at the FDA in the midst of the pandemic is extremely important,” Karine Jean-Pierre, the White House’s deputy press secretary, said Monday. She pointed to the meetings and phone calls that Dr. Califf, the White House and their allies had undertaken to build support for her confirmation.

The agency plays a key role as the guardian of the vaccines, tests and treatments available to Americans and regulates the foods, drugs, cosmetics and tobacco products that account for 20 cents of every dollar of consumer spending. in the USA.

The new commissioner will have a lot of work to do. The agency is facing high-profile decisions on e-cigarette marketing apps, with tobacco opponents watching with concern the lingering appeal of vaping among young people. Lawmakers are eager to see changes in how the agency gets drugs to market after the controversial approval of Alzheimer’s disease drug Aduhelm. And the agency faces a long backlog of foreign inspections, as around 80% of the drugs’ active ingredients come from abroad.

Dr. Califf has spent most of his career at Duke University, where he was a professor of medicine and founding director of the Duke Clinical Research Institute. He has led numerous clinical trials in cardiology, gained experience working with the pharmaceutical industry, and gained wide respect in the field of medicine.

This position is crucial, said Dr. David J. Skorton, president of the Association of American Medical Colleges.

“Decisions made by an FDA commissioner or the FDA in general will not always please everyone,” Dr. Skorton said. “These are very, very difficult decisions,” he said. Noting that he had followed Dr Califf’s career for decades, Dr Skorton described him as “the person of the hour”.


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