The Senate narrowly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration, a major federal agency that has not had a permanent chief over the coronavirus pandemic for more than a year.
The vote was 50-46, with six Republicans crossing the aisle in support of him, while five Democrats were against him. One senator voted in attendance.
In recent weeks, Dr. Califf on a second affirmation of growing as opposition grew over concerns about how he would respond to the opioid epidemic and the agency’s handling of abortion drug rules. The White House responded by seeking support in Congress and among other allies, with mainstream medical associations and a bipartisan group of six former FDA commissioners calling Dr. Califf came in defense.
North Carolina Republican Senator Richard Burr was one of a handful of GOP senators who named Dr. Califf supported and offset the opposition of some Democrats. On Tuesday, Mr. Burr called on other senators to get Dr. Califf, saying the FDA was without a permanent leader for 391 days.
“I urge my colleagues to support Dr. Califf’s nomination as he will provide the leadership needed to promote today’s biomedical advancements and pave the way for tomorrow’s innovation,” said Mr. . burr.
Despite some support from Republicans, senators in both parties, ranging from liberal Democrats suspicious of its ties to the drug industry to conservative Republicans closely associated with the anti-abortion movement, formed formidable opposition.
In contrast, Dr. Califf assumed the role of commissioner in a vote of 89 to 4 in 2016, 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 with the pharmaceutical industry during the opioid epidemic that had already killed thousands in 2016.
On Friday, Mr. Manchin called on Mr. Biden to withdraw the nomination in an opinion essay, noting that while Dr. Califf promised to make changes the last time he was a commissioner, the FDA approved five new opioids in 2016 and 2017.
“I’ve never had as much confidence in a vote I’m about to cast as I am now,” Mr Manchin said in a fiery speech on Monday, placing the partial blame for the worsening epidemic on Dr. Califf explained. Opposition to his appointment, Mr. Manchin added, would “send a message to this administration, to our president, that we need a new direction at the FDA.”
“We need people who want to protect us,” he concluded, “not people who let drugs destroy us.”
Just before Tuesday’s vote, Massachusetts Democrat Senator Edward Markey denounced the FDA’s role in becoming the “greatest pill-driver in the country” and said Dr. Califf did little to address the problem in his previous stint as commissioner.
“There was no real commitment to reform the FDA or to learn from the mistakes that made this public health crisis possible,” said Mr. Markey.
dr. Califf also faced pressure from abortion enemies because of the FDA’s risk management policies regarding abortion medications. The influential Susan B. Anthony List organization, which opposes abortion, has reached out to lawmakers about changes made during Dr. Califf as commissioner and who have facilitated access to medical abortion pills.
At a Senate hearing in December, Dr. Califf expresses confidence in the agency’s ability to make drug decisions again. Two days after that hearing, the FDA announced that women could receive the pills in the mail after a telehealth appointment, eliminating the need for an in-person evaluation.
The Susan B. Anthony List announced that it is voting on the nomination of Dr. Califf would “score,” meaning it will factor into the organization’s assessments for lawmakers’ “pro-life scorecard.” Republicans who are up for re-election often seek the support of the group.
Senator Steve Daines, Republican from Montana, spoke in opposition before the vote, criticizing Dr. Califf on the changes in abortion medication.
“Dr. Califf has refused to back down from the FDA’s decision to leave vulnerable pregnant women to the reckless and predatory actions of the abortion industry,” Daines said.
The supporters of Dr. Califf argued that the agency was long overdue for permanent leadership, especially as the agency struggles to review coronavirus vaccines for young children on top of other health crises.
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“Dr. Califf’s previous service in this role, his career as one of the nation’s foremost research scientists, gives him the experience to meet this challenge,” said Washington Sen. Patty Murray, chair of the Senate Committee on Health, Education, Labor. and pensions. †
“It is critical to have confirmed leadership at the FDA in the midst of the pandemic,” Karine Jean-Pierre, deputy White House press secretary, said Monday. She underlined the meetings and phone calls Dr. Califf, the White House and their allies had taken steps to bolster support for his confirmation.
The agency plays a key role as a gatekeeper to the vaccines, tests and treatments Americans have access to, regulating food, drugs, cosmetics and tobacco products that represent 20 cents of every dollar of U.S. consumer spending.
The incoming Commissioner will have a lot of work to do. The agency faces high-profile decisions about marketing applications for e-cigarettes, as tobacco opponents look concerned at the lingering temptation of youth vaping. Lawmakers are eager to see changes to the way the agency brings drugs to market soon after the controversial approval of the Alzheimer’s drug Aduhelm. And the agency has a long backlog of foreign inspections, as about 80 percent of active ingredients in drugs come from abroad.
dr. Califf spent most of his career at Duke University, where he served as a professor of medicine and founding director of the Duke Clinical Research Institute. He led numerous clinical studies in cardiology, gained experience working with the pharmaceutical industry and earned a lot of respect in the field of medicine.
That status is crucial, said Dr. David J. Skorton, president of the Association of American Medical Colleges.
“The decisions made by an FDA commissioner or the FDA in general will not always please everyone,” said Dr. skorton. “It’s very, very difficult decisions,” he said. dr. Skorton noted that he took the career of Dr. Califf followed for decades and described him as “the person for the hour”.