Senate confirms Caliph as FDA chief with a tough vote

On Tuesday, the Senate narrowly confirmed Dr. Robert Caliph as Commissioner of Food and Drugs. This is a major federal agency that has had a coronavirus pandemic for over a year.

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

Over the last few weeks, the odds of Dr. Caliph’s second confirmation have looked longer and longer. Opposition mounts Concerns about how he responds to the opioid epidemic and the handling of authorities in abortion drug regulations. The White House responded by a bipartisan group of mainstream medical societies and six former FDA members coming to Dr. Caliph’s defense in an attempt to gain support within Congress and other allies.

Senator Richard Burr, a Republican in North Carolina, was one of the few GOP senators to support Dr. Calif and offset some Democratic opposition. On Tuesday, Mr. Barr called on other senators to confirm Dr. Caliph, saying the FDA had spent 391 days without a permanent leader.

“I urge my colleagues to support Dr. Caliph’s nomination because he provides the leadership needed to drive advances in biomedicine today and pave the way for tomorrow’s innovation,” Barr said. He said.

Despite Republican support, senators from both parties have expressed formidable opposition, from the Liberal Democratic Party, which dislikes relations with the pharmaceutical industry, to the conservative Republican Party, which has kept pace with the anti-abortion movement.

In contrast, Dr. Caliph, with strong support from both sides of the aisle, blew a breeze into the role of commissioner in 2016 with an 89-4 vote. Some of the headwinds he has faced since President Biden nominated him in November came from the same Democratic senator who opposed him six years ago. At that time, Senator Joe Manchin of the Democratic Party of West Virginia, Expressing concern About the relationship between Dr. Caliph and the pharmaceutical industry in an opioid epidemic that has already killed thousands by 2016.

On Friday, Manchin asked Biden to withdraw his nomination. Opinion essayThe FDA promised to make changes the last time Dr. Caliph served as Commissioner. Approved 5 new opioids in 2016 and 2017..

“I’ve never been more confident in voting than I am now,” Manchin said in a fierce floor speech on Monday, directly blaming Dr. Caliph’s epidemic for worsening. “I’m sending the administration a message that the FDA needs a new direction,” Manchin added, in opposition to his nomination.

“We need someone who wants to protect us. We don’t allow drugs to destroy us,” he concludes.

Just before Tuesday’s vote, Massachusetts Democrat Senator Edward Marquee condemned the FDA’s role in becoming “the country’s largest pill pusher,” and Dr. Caliph’s previous mission as commissioner. Said that he rarely dealt with the problem.

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

Dr. Caliph also faced pressure from abortion enemies over the FDA’s risk management policies related to abortion drugs. The influential Susan B. Anthony List organization, which opposes abortion, visited lawmakers about Dr. Caliph’s change as a member during his predecessor. Easy access For abortion drugs.

At a Senate hearing in December, Dr. Caliph was confident in the institution’s ability to process drug decisions again. Two days after the hearing, Announced by FDA Women can receive pills by mail after booking telemedicine, eliminating the need for face-to-face evaluation.

Susan B. Anthony List announced: It “scores” Voting for Dr. Caliph’s nomination. This means that it will be taken into account in the organization’s assessment of parliamentarians.Pro life scorecard.. Republicans seeking reelection often seek the support of the group.

Senator Steve Daines, a Republican in Montana, disagreed before the vote and criticized Dr. Caliph’s role in changing the abstinence drug.

“Dr. Caliph refused to stay away from the FDA’s decision to abandon vulnerable pregnant women into reckless and predatory actions in the abortion industry,” Daines said.

Dr. Caliph’s supporters, especially the agency Review of coronavirus vaccine for infants In addition to other health crises.

“Dr. Calif’s previous job in this position was a career as one of the leading research scientists in the United States, giving him the experience to tackle this challenge,” said Senate Health Education Labor Pensions Commissioner. Washington Senator Patimarey, who chairs the meeting, said. ..

“It’s very important to confirm leadership at the FDA in the midst of a pandemic,” White House Deputy Press Secretary Karine Jean-Pierre said on Monday. She emphasized meetings and phone calls, and Dr. Caliph, the White House and its allies set out to step up support for his confirmation.

The agency plays an important role as a gatekeeper for vaccines, tests and treatments accessible to Americans, regulating food, medicine, cosmetics and tobacco products. 20 cents per dollar For personal consumption in the United States.

The next commissioner has a lot to do. Agencies are faced with a hot decision regarding e-cigarette marketing applications, and tobacco opponents are concerned about the persistent temptation to inhale the vapors of young people. Lawmakers want government agencies to see subsequent changes in the way medicines are quickly tracked to the market. Controversial Approval of the drug Aducanumab for Alzheimer’s disease.And the agency, broadly speaking, has a long backlog of foreign inspections to deal with. 80 percent Many of the active ingredients in pharmaceutical products come from overseas.

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

That position is very important, said Dr. David J. Skolton, President of the American Medical College Association.

“The decisions made by the FDA Commissioner or the FDA in general do not always please everyone,” said Dr. Skolton. “They are very, very difficult decisions,” he said. Noting that Dr. Caliph’s career has continued for decades, Dr. Skoton described him as “the person of the time.”