The White House is under pressure from prominent lawmakers over its choice to head the Food and Drug Administration, with abortion foes urging Republican senators to reject candidate, Dr. Robert Califf, and with key Democrats withholding support over opioid policy and its ties to the industry.
Nearly six years after Dr. Califf received overwhelming bipartisan support to lead the agency in the final year of the Obama administration, lawmakers and aides struggle to get the votes he needs to purge an evenly divided Senate where Vice President Kamala Harris serves as the deciding vote.
Few, if any, nominees to the FDA have faced so much opposition on both sides of the aisle, and the agency hasn’t had a standing commissioner for over a year. The agency’s agenda covers a range of key issues: oversight of drugs, tests and devices related to Covid-19; the pandemic-related decline in inspections of drug and device manufacturers; and the popularity of flavored e-cigarette products among teens.
Government officials have been trying to get support for Dr. Califf and say he still has the support of President Biden and top health officials. Democratic Senate leaders also continue to publicly support him. But no date has been set for his confirmation vote for the full Senate. At least five Democrats publicly oppose his nomination, so Dr. Califf needs at least five Republicans to back him.
“We are confident that Dr. Califf will be confirmed with bipartisan support, and having confirmed leadership at the FDA amid a pandemic is critical,” said Chris Meagher, a White House spokesperson. dr. Califf has declined interview requests while his nomination is pending.
This week, some senators seemed unsure whether Dr. Califf would survive the divisions over his candidacy. “I’m not sure if that will come to a vote, and then I’ll make a final decision,” Missouri Republican Senator Roy Blunt said. “I like him as a person, I think he can do the job and let’s see what else happens between now and the vote.”
The prospects for a quick vote could be further complicated by the absence of New Mexico Democrat Senator Ben Ray Luján, who is recovering from a stroke. A senior aide to Mr Luján said on Wednesday he remained in hospital and would return in four to six weeks unless there are complications. Mr Luján voted for Dr. Califf.
Notable Democrats — including Senators Joe Manchin III of West Virginia, a major centrist, and Bernie Sanders of Vermont, the independent — have publicly announced that they will oppose the candidate because of his ties to the pharmaceutical industry and his handling of the opioid crisis during the Obama administration.
“In terms of healthcare, in terms of the FDA, we need aggressive leadership that is willing to address the pharmaceutical industry’s greed,” said Mr. Sanders. “Unfortunately, I don’t think Dr. Califf is that person.”
dr. Califf approved a vote in the Senate Committee on Health, Education, Labor and Pensions in January with support from Republicans. Four senators walked down the aisle to advance the nomination: Richard Burr of North Carolina, the highest-ranking member of the committee; Susan Collins of Maine; Lisa Murkowski from Alaska; and Mitt Romney of Utah.
South Dakota Senator John Thune, the second Republican in the Senate, said on Wednesday that Dr. Califf boded well for his prospects for many in his party, though concerns about his role in abortion decisions drove others away.
“It’s hard for me to say at this point where our members will be,” said Mr Thune, “but I know opinions are divided.”
Two Democrats — Mr. Sanders and New Hampshire Senator Maggie Hassan, who face a tough re-election in a state hit hard by opioids — opposed the choice, and more Democrats were said to lean against his nomination. All three Democrats who opposed the first confirmation of Dr. Califf to the post, Mr. Manchin and Senators Ed Markey of Massachusetts and Richard Blumenthal of Connecticut will remain in office.
Mr. Markey’s office confirmed that he was against Dr. Califf would vote. Mr Blumenthal said on Tuesday that if the vote were to take place that day, he would do the same.
“I still strongly believe there is a need for a new era and leadership that will separate the FDA from the pharmaceutical industry in a very public and important way,” said Mr. Blumenthal, adding that he had lingering concerns after a conversation with dr. caliph . On Wednesday, he repeated his resistance.
dr. Califf has made the Senate round, meeting an estimated 45 members, one of the most scheduled for any Biden nominee. Aid workers personally indicated that they believed they could muster the necessary support for his appointment. This week, Mr. Burr predicted, “I think Dr. Califf will be the next FDA commissioner.”
Despite concerns from Mr. Manchin and other Democrats, Dr. Califf was appointed to the position in November. Mr. Manchin, whose state has been devastated by the opioid epidemic, has outlined numerous changes he would like to see with the FDA, including mandatory training for opioid prescribers, similar to the training required for those who prescribe drug addiction.
The senator’s concerns over the crisis have hampered negotiations on Biden’s major $2.2 trillion domestic policy bill as Mr. Manchin rejected plans to expand the child tax credit over concerns that those monthly payments to families with children were being used to to buy opioids.
“I strongly opposed his appointment, which is an insult to those affected by the drug epidemic,” said Mr Manchin. on Twitter on the day of the panel’s vote, adding: “It is time for the FDA to have leadership that is willing to step forward to protect Americans from the drug epidemic that continues to plague our country. dr. Califf isn’t that leader.’
Several senators, who this week expressed their support for Dr. Califf insisted, saying they hadn’t made a decision yet.
West Virginia Republican Senator Shelley Moore Capito said she was still undecided: “I know there are some issues that have come up, but he’s been to West Virginia — he’s seen first-hand what we’ve been up to.” to have. That is important to me.”
The FDA commissioner’s role has been subject to Senate confirmation since 1988, unlike the director of the Centers for Disease Control and Prevention, who is a presidential appointee. The nominee is often subject to sharp questions, but observers say the decision has never been more involved in national politics that has nothing to do with the nominee’s qualifications.
With no confirmed leader, Dr. Janet Woodcock, the Interim Commissioner, while the nomination is pending. If the appointment of Dr. Califf is rejected, she could run the agency for another 210 days, said Charles Young, a spokesman for the Government Accountability Office.
dr. Califf spent much of his career conducting cardiology studies at Duke University medical school, where he earned a reputation as an unbiased expert. In 2017, he joined Verily, the life sciences arm of Alphabet, the parent company of Google.
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As the head of clinical policy and strategy there, he earned $2.7 million in revenue and between $1 million and $5 million in stock, according to his ethical disclosure. He also held lucrative leadership roles at pharmaceutical and biotech companies developing drugs for patients with hemophilia and impaired muscle function. In an effort to gain more support, he promised Massachusetts Democrat Senator Elizabeth Warren that he would abide by additional restrictions to segregate any board decisions from his previous work.
“The FDA nominee has agreed to go beyond the current legal requirement to foreclose upon himself from participating in the revolving door after his government service and isolate himself from interactions with former employers during his tenure,” said Ms. Warren. “Since he was willing to make a public commitment to stop the revolving door, I will support him.”
Some critics of Dr. Califf cite his track record with the FDA, where he served as the agency’s deputy commissioner for medical products and tobacco from 2015 and the agency’s Senate-confirmed commissioner in 2016 and 2017.
The anti-abortion group Susan B. Anthony List leads a coalition that pressures Republican senators to oppose Dr. Calif to vote. The group criticized changes to drug abortion policies, which became less restrictive in 2016 when Dr. Califf ran the office. “In 2016, he was a nominee without a record; now he’s a nominee with a track record of ignoring life,” the group wrote.
The group also opposes Dr. Califf for his responses to questions at the Dec. 14 committee hearing on the agency’s pending decision on the medical abortion drug mifepristone. dr. Califf said he was confident that the agency would make the right decision with the evidence available.
Two days later, the FDA announced it would permanently allow telehealth providers to prescribe abortion medications at home.
Tommy Tuberville of Alabama, Mike Braun of Indiana and Roger Marshall of Kansas, all Republicans, voted on the committee against Dr. Califf, in part because of abortion-related issues, employees confirmed.
The advocacy group also urges Mr. Romney, who was one of four Republicans on the Senate Committee on Health, Education, Labor and Pensions to vote in favor of Dr. Califf voted.
Some of the legislators’ concerns about opioid policy are also based on Dr. Califf as commissioner in 2016. Three months into his tenure, the Centers for Disease Control and Prevention issued new guidelines and a searing commentary outlining the often fatal risks of opioid drugs amid “unproven and transient benefits.”
Rather than follow up on policy changes, Dr. Califf commissioned another study, said Dr. Andrew Kolodny, a critic of the FDA’s opioid policy who has advised Mr. Manchin, Mr. Markey and Ms. Hassan.
If dr. Califf confirms, “there’s a chance he can do something and then we might finally get somewhere,” says Dr. Kolodny, medical director of the Opioid Policy Research Collaborative at Brandeis University. “But I wouldn’t hold my breath. Because I think he’s an industry man at the end of the day.”
Nearly 100,000 Americans died from opioid overdoses in 2020, the CDC reported, although many of the deaths were related to illicit fentanyl.
Sheryl Gay Stolberg contributed reporting.
