Senate confirms Califf as FDA chief in close vote

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

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

In the past few weeks, Dr. Califf’s chances of a second confirmation grew longer as opposition mounted over concerns about how he would respond to the opioid epidemic and the agency’s handling of abortion drug regulations. The White House responded by attempting to rally support in Congress and among other allies, with mainstream medical societies and a bipartisan group of six former FDA commissioners rallying in defense of Dr. Calif came.

Senator Richard Burr, a Republican from North Carolina, was one of a handful of GOP senators who Dr. Califf and balanced opposition from some Democrats. On Tuesday, Mr. Burr urged other senators to ask Dr. Califf, saying the FDA has been without a permanent leader for 391 days.

“I urge my colleagues to accept the nomination of Dr. Supporting Califf as he will provide the leadership needed to drive today’s biomedical advances and help pave the way for tomorrow’s innovations,” said Mr. Burr.

Despite some Republican support, senators from both parties, from liberal Democrats suspicious of his ties to the pharmaceutical industry to conservative Republicans who are in lockstep with the anti-abortion movement, have met with fierce opposition.

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

On Friday, Mr. Manchin urged Mr. Biden to withdraw the nomination opinion essaynoting that while Dr. Califf promised to make changes the last time he was commissioner, the FDA approved five new opioids in 2016 and 2017.

“I’ve never been more confident about a vote I’m going to cast than I am now,” Mr Manchin said Monday in a fiery speech addressing Dr. Califf directly blamed part of the worsening of the epidemic. Opposition to his nomination, Mr. Manchin added, would “send a message to this administration, to our president, that we need new direction at the FDA.”

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

Shortly before Tuesday’s vote, Senator Edward Markey, a Democrat from Massachusetts, denounced the FDA’s role in becoming the “biggest pill pusher in the country,” saying Dr. Califf had done little to address the problem in his previous tenure as commissioner.

“There was no real commitment to reform the FDA or to learn from the mistakes that made this public health crisis possible,” Mr. Markey said.

dr Califf has also faced pressure from anti-abortion advocates over FDA risk management guidelines regarding abortion drugs. The influential anti-abortion organization Susan B. Anthony List has questioned lawmakers about changes made during Dr. Califf’s previous tenure as Commissioner and facilitated access to medicated abortion pills.

During a Senate hearing in December, Dr. Califf expressed his confidence in the agency’s ability to make decisions about the drugs again. Two days after that hearing, the FDA announced that women could receive the pills in the mail after a telemedicine appointment, eliminating the need for an in-person exam.

This was announced by the Susan B. Anthony List it would “score” the vote on the nomination of Dr. Califf, which means she is included in the organization’s reviews for lawmakers.Pro-Life Scorecard.” Republicans running for re-election often seek group support.

Senator Steve Daines, Republican of Montana, spoke out before the vote in opposition and criticized Dr. Califf’s role in the abortion medication changes.

“DR. Califf has refused to distance himself from the FDA’s decision to surrender vulnerable pregnant women to the ruthless and predatory actions of the abortion industry,” said Mr. Daines.

The supporters of Dr. Califf argued that the agency is long overdue for permanent leadership, especially as the agency wrestles with reviewing infant coronavirus vaccines in addition to other health crises.

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

“It is critical to have confirmed the FDA’s leadership in the midst of the pandemic,” Karine Jean-Pierre, the White House deputy press secretary, said Monday. She underscored the meetings and phone calls that Dr. Califf, the White House and their allies had done to secure support for his confirmation.

The agency plays a key role as the gatekeeper for the vaccines, tests, and treatments Americans have access to, and regulates the foods, drugs, cosmetics, and tobacco products that are responsible for them 20 cents of every dollar of US consumer spending.

The new commissioner will have a lot to do. The agency faces high-profile decisions on marketing proposals for e-cigarettes, with anti-tobacco activists watching with concern over the lingering lure of teenage vaping. Lawmakers are excited about changes in the way the agency markets drugs following the controversial approval of Alzheimer’s drug Aduhelm. And the agency, to put it bluntly, has a long backlog of foreign inspections to deal with 80 percent Active ingredients come from overseas.

dr Califf spent most of his career at Duke University, where he served as professor of medicine and founding director of the Duke Clinical Research Institute. He led numerous clinical studies in cardiology, gained experience in the pharmaceutical industry and gained wide recognition in medicine.

That reputation is critical, said Dr. David J. Skorton, President of the Association of American Medical Colleges.

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

Comments are closed.