The San Juan Daily Star
Senate confirms Califf as FDA chief in tight vote
By Christina Jewett and Emily Cochrane
The Senate earlier this week narrowly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration, a key federal agency that has been without a permanent chief for more than a yearlong stretch of the coronavirus pandemic.
The vote was 50-46, with six Republicans crossing the aisle to support him while five senators who caucus with Democrats opposed him. One senator voted present.
Califf, who is 70, is expected to be sworn in this week. He faces a looming flurry of decisions — including intense scrutiny of a coronavirus vaccine for children under 5 and reviews of e-cigarette applications like Juul’s bid to stay on the market.
In recent weeks, Califf’s odds of a second confirmation looked increasingly long as opposition mounted 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 trying to rally support in Congress and among other allies, with mainstream medical societies and a bipartisan group of six former FDA commissioners coming to Califf’s defense.
Sen. Richard Burr, R-N.C., was one of a handful of GOP senators who backed Califf and offset some Democrats’ opposition. On Tuesday, Burr called on other senators to confirm Califf, saying the FDA had gone 391 days without a permanent leader.
“I urge my colleagues to support Dr. Califf’s nomination because he will provide the leadership needed to promote today’s biomedical advancements and help to pave the way for tomorrow’s innovation,” Burr said.
Despite some Republican support, senators in both parties, ranging from liberal Democrats leery of his ties to the pharmaceutical industry to conservative Republicans in lockstep with the anti-abortion movement, posed formidable opposition.
By contrast, Califf breezed into the commissioner role in 2016 in a vote of 89-4, with strong support from both sides of the aisle. Some of the headwinds he has faced since President Joe Biden nominated him in November are from the same Democratic senators who opposed him six years ago. Back then, Sen. Joe Manchin, D-W.Va., voiced concerns about Califf’s ties to the pharmaceutical industry amid the opioid epidemic that by 2016 had already killed thousands.
On Friday, Manchin called on Biden to withdraw the nomination in an opinion essay, noting that while Califf pledged to make changes the last time he was commissioner, the FDA approved five new opioids in 2016 and 2017.
“I have never been more profoundly confident of a vote I’m going to cast than I am right now,” Manchin said in a fiery floor speech Monday, directly placing partial blame for the worsening epidemic on Califf. Opposition to his nomination, 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 allow drugs to destroy us.”
Just before the vote Tuesday, Sen. Edward Markey, D-Mass., denounced the FDA’s role in becoming the “country’s biggest pill pusher” and said Califf did little to address the problem in his previous stint as commissioner.
“There was no real commitment to reforming the FDA or to learning from the mistakes that enabled this public health crisis,” Markey said.
Califf also faced pressure from abortion foes over the FDA’s risk-management policies related to abortion medications. The influential Susan B. Anthony List organization, which opposes abortion, has canvassed lawmakers about changes made during Califf’s prior tenure as commissioner that eased access to medication abortion pills.
During a Senate hearing in December, Califf expressed confidence in the agency’s ability to handle decisions about the medications again. Two days after that hearing, the FDA announced that women could receive the pills by mail after a telehealth appointment, eliminating a requirement for an in-person evaluation.
The Susan B. Anthony List announced that it would “score” the vote on Califf’s nomination, meaning it will be considered in the organization’s assessments for lawmakers’ “pro-life scorecard.” Republicans up for reelection often seek the group’s endorsement.
Sen. Steve Daines, R-Mont., spoke in opposition before the vote, criticizing Califf’s role in the abortion medication changes.
“Dr. Califf has refused to distance himself from the FDA decision to abandon vulnerable pregnant women to the reckless and predatory actions of the abortion industry,” Daines said.
Five senators who caucus with Democrats — Manchin and Sens. Bernie Sanders of Vermont, Maggie Hassan of New Hampshire, Markey of Massachusetts and Richard Blumenthal of Connecticut — opposed the nomination.
Six Republicans — Sens. Burr, Lisa Murkowski of Alaska, Susan Collins of Maine, Mitt Romney of Utah, Roy Blunt of Missouri and Pat Toomey of Pennsylvania — tipped the balance for confirmation. Of those Republicans, just one — Murkowski — is up for reelection and three — Blunt, Burr and Toomey — are retiring.
While Sen. Mike Rounds, R-S.D., was opposed to the confirmation, he was marked as present as part of a pairing with Sen. Ben Ray Luján of New Mexico, who is recovering from a stroke and would have voted yes.
Sen. Elizabeth Warren, D-Mass., said in a statement that Califf secured her vote after agreeing to refrain from seeking employment with or compensation from any drug or device company for four years after his term as commissioner.
The incoming commissioner will have plenty of work to do. The agency is facing an end-run around its tobacco control authority with companies marketing synthetic tobacco in flavors attractive to teenagers. Lawmakers are eager to see changes in how the agency fast-tracks drugs to the market after the controversial approval of the Alzheimer’s drug Aduhelm. And the agency has a lengthy backlog of foreign inspections to contend with, as roughly 80% of active drug ingredients come from overseas.
Dr. Janet Woodcock, the interim commissioner, issued a statement Tuesday, saying she will stay on as a principal deputy at the agency. She has been a target of lawmakers who say the agency spurred the opioid epidemic, which could prove relevant as leaders turn to Congress for new authority to tackle a range of issues.
After the confirmation votes, advocates and supporters issued statements urging action on a variety of issues. The Environmental Working Group called on Califf to remove PFAS, known as “forever chemicals,” from food packaging and to require companies that sell talc to test their products for asbestos.
Rep. Rajna Krishnamoorthi, D-Ill., called on Califf to address his House subcommittee’s findings of arsenic and lead in baby food. Sen. Dick Durbin, D-Ill., asked Califf to address “predatory tactics” of vaping companies targeting young people.
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 trials in cardiology, gained experience working with the pharmaceutical industry and drew widespread respect in the field of medicine.
That standing is crucial, said Dr. David J. Skorton, president of the Association of American Medical Colleges.
“The decisions that are made by an FDA commissioner or the FDA in general are not always going to please everybody,” Skorton said. “They are very, very difficult decisions.” Noting that he had followed Califf’s career for decades, Skorton described him as “the person for the hour.”