Senate Approves Califf as FDA Chair in Tight Vote

On Tuesday, the Senate announced Dr. He narrowly approved of Robert Califf.

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

In recent weeks, Dr. Califf’s prospect of a second confirmation seemed increasingly long. opposition mounted Out of concerns about how it will respond to the opioid epidemic and how the agency will handle abortion drug rules. The White House, mainstream medical associations, and a bipartisan group of six former FDA commissioners, Dr. Coming to the defense of Califf, he responded by trying to garner support in Congress and among other allies.

North Carolina Republican Senator Richard Burr, Dr. He was one of a handful of GOP senators who supported Califf and balanced opposition from some Democrats. Burr on Tuesday said that 391 days had passed without a permanent leader of the FDA, saying that his fellow senators, Dr. He urged Califf to confirm.

Mr. Burr said, “I would like to thank my colleagues, Dr. “I urge you to support Califf’s candidacy because he will provide the leadership needed to support biomedical advances today and help pave the way for tomorrow’s innovation.”

Despite some Republican support, senators in both parties have displayed fierce opposition, from liberal Democrats cautious about their ties to the pharmaceutical industry to conservative Republicans who are key strides in the anti-abortion movement.

In contrast, Dr. With strong support from both sides of the aisle, Califf moved into the commissioner role in 2016 by 4 votes to 89. Some of the challenges President Biden has faced since nominating him in November come from the same Democratic senators who opposed him six years ago. At the time, West Virginia Democratic Senator Joe Manchin III, the concerns expressed Dr. About Califf’s ties to the pharmaceutical industry amid the opioid epidemic that killed thousands by 2016.

On Friday, Mr. Manchin urged Mr. Biden to withdraw the nomination. opinion letterDr. Despite Califf’s promise to make changes when he was the last commissioner, the FDA’s Approved five new opioids in 2016 and 2017.

“I’ve never been more sure of a vote to cast,” Mr. Manchin said in a heated floor speech Monday, and partly directly blamed Dr. He blamed Califf. Mr Manchin added that opposition to his nomination will “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 finished, “not people who let drugs destroy us.”

Just before Tuesday’s vote, Massachusetts Democratic Senator Edward Markey denounced the FDA’s role as “the nation’s largest seller of pills,” and Dr. He said Califf had done little to fix the problem in his previous role 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 has also faced pressure from abortion foes over the FDA’s risk management policies regarding abortion drugs. The influential organization Susan B. Anthony List, which opposes abortion, deputies Dr. easy access for abortion pills.

During a Senate hearing in December, Dr. Califf expressed confidence in the agency’s ability to reconsider decisions about drugs. Two days after this trial, FDA announced The fact that women can receive the pills by mail after a telehealth appointment eliminates the need for a face-to-face evaluation.

Susan B. Anthony List explained would be “points” Dr. The vote on Califf’s candidacy will be taken into account in the organization’s assessments of MPs.”pro-life scorecard“Re-election Republicans often seek the approval of the group.

Montana Republican Senator Steve Daines spoke to the opposition before the vote, and Dr. He criticized Califf’s role in abortion drug changes.

“Dr. Califf refused to shy away from the FDA’s decision to abandon vulnerable pregnant women to the reckless and predatory actions of the abortion industry,” he said.

Dr. Califf’s supporters argued that the agency was too late for permanent leadership, especially as the agency grappled with the government. review of coronavirus vaccines for young children above other health crises.

“Dr. Califf’s previous 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 Health, Education, Work and Retirement Committee.

“Confirming FDA leadership is critically important amid the pandemic,” Karine Jean-Pierre, deputy White House press secretary, said on Monday. Dr. Califf, the White House and its allies, Dr. He highlighted the meetings and phone calls they undertook to support Califf’s endorsement.

The agency plays a key role as the gatekeeper for vaccines, tests and treatments accessible to Americans and regulates food, pharmaceuticals, cosmetics and tobacco products. 20 cents on every dollar US consumer spending

The incoming commissioner will have a lot of work to do. The agency is faced with high-profile decisions regarding e-cigarette marketing practices, and anti-tobacco enthusiasts watch with concern the enduring appeal of youth e-cigarette use. Lawmakers are keen to see changes in how the agency is fast-tracking drugs to market. controversial Approval of Alzheimer’s drug Aduhelm. And the agency has, roughly speaking, a long pile of foreign inspections to deal with. 80 percent active drug 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 has spearheaded numerous clinical trials in cardiology, gained experience working with the pharmaceutical industry, and is widely respected in the medical field.

President of the Association of American Medical Colleges, Dr. David J. Skorton said that this stance is very important.

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