Biden’s FDA pick finds himself in tough confirmation battle

By Kaitlan Collins, Lauren Fox and Brenda Goodman, CNN

President Joe Biden‘s pick to lead the US Food and Drug Administration has found himself locked in an intense confirmation battle as he fights to secure enough votes to run the agency that’s at the forefront of the pandemic.

Dr. Rob Califf, a longtime cardiologist, was last confirmed to run the sprawling agency during President Barack Obama’s final year in office by an 89-4 vote. But it has been challenging for Califf to find anywhere near the same level of support from senators this time around and the White House is bracing for a narrow vote, according to several sources who spoke with CNN.

Biden announced in November that he was selecting Califf to return as the agency’s head following a frustrating, months-long search to find a nominee who the White House thought could win Senate confirmation. Since then, Califf has met with 33 senators and has plans to meet with another 14 in the coming weeks, according to an administration official. The meetings have been almost equally split between Democrats and Republicans.

“We are confident Dr. Califf will be confirmed with bipartisan support, and it is critical to have confirmed leadership at the FDA in the midst of a pandemic,” White House spokesman Chris Meagher told CNN.

But the math surrounding Califf’s nomination is far from certain.

Sen. John Thune of South Dakota, the Republican whip, warned that Democrats have some defections to deal with and, while he believes there could be enough Republicans to save him, several GOP members haven’t officially decided yet.

“We haven’t done anything official on it yet, but my sense is that there are some Republicans who are prepared to support him,” Thune told CNN. “I just don’t know how many defections they have on their side, so it is hard to say if that nets out, but a lot of our members are more concerned now about recent revelations about his pro-life views, so that will cost him some Republican votes.”

During his last confirmation process, Califf faced stiff opposition from multiple Democrats, including Sen. Joe Manchin of West Virginia, who criticized his ties to the pharmaceutical industry and has declared he won’t support him this time around either.

“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic,” Manchin said in a blistering statement. “Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward. His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction.”

Sen. Richard Blumenthal, a Democrat from Connecticut, echoed Manchin and called for fresh leadership at the FDA.

“I think there is a need for a clean break, a new era and greater independence,” Blumenthal told CNN.

The White House has ramped up its lobbying effort on Califf’s behalf in recent weeks after it became clear he wouldn’t sail through confirmation. Officials in the West Wing are in daily contact with the Department of Health and Human Services, which is running point on Califf’s nomination, and some of Biden’s top lieutenants, like senior adviser Steve Richetti, have called people on Califf’s behalf.

Califf himself has sought to sway undecided lawmakers, making multiple trips to Capitol Hill, sometimes for frank one-on-one conversations.

“I think I am going to support him,” Democratic Sen. John Hickenlooper of Colorado told CNN after he had met with Califf. “We had a very blunt, serious conversation. We discussed opioids and the issues surrounding how opioid prescriptions got so out of hand and whether there were sufficient consequences.”

A coalition of pro-life groups, including the Susan B. Anthony List, have urged members to vote against his nomination after Califf said during his confirmation hearing that he trusted the FDA’s process when asked about the agency’s decision to allow abortion pills to be sent by mail.

“Califf has a record of putting the abortion lobby’s extreme agenda ahead of women’s safety and the lives of unborn children. There is little doubt he will permanently authorize mail-order abortions if confirmed to lead the FDA,” said Susan B. Anthony List President Marjorie Dannenfelser in a statement last month.

Califf’s fight to get confirmed comes at a time when those inside the agency say permanent leadership is desperately needed.

The last time he was head of the FDA, Califf oversaw the controversial 2016 approval of eteplirsen, a drug used to treat Duchenne muscular dystrophy, a rare form of the genetic disorder. In a review of the decision, Califf backed now-acting commissioner Dr. Janet Woodcock, who went against the FDA’s independent advisory group that recommended against eteplirsen’s approval.

Duchenne muscular dystrophy has no cure, and at the time the only other approved treatment was steroids, which had severe side effects. The disorder primarily affects boys and is usually diagnosed by the age of 5. Many with Duchenne rely on wheelchairs as their muscles quickly lose strength and begin to have difficulty breathing around age 20. Ultimately, many die from lung disorders within a few years after that.

Prior to running the agency, Califf served as the FDA’s deputy commissioner for medical products and tobacco. He was a professor of medicine and a vice chancellor for clinical and translational research at Duke University before joining the FDA. He was also the director of the Duke Translational Medicine Institute and is the founding director of the Duke Clinical Research Institute.

“He could help provide the leadership, the stability there that’s badly needed right now,” Dr. Eric Topol, director of the Scripps Research Translational Institute and professor of molecular medicine, told CNN about the FDA now. “They’re a stressed-out group. They’ve worked really hard and done really well but getting leadership there will be important.”

In the fight for his confirmation, Califf has been able to win over some on the progressive side of the Democratic caucus who had concerns about his prior connections to the pharmaceutical industry.

Sen. Elizabeth Warren, a Massachusetts Democrat, confirmed to CNN she will vote yes on his nomination after meeting with Califf in January. During the meeting, she asked that he sign an ethics pledge that goes further than the administration’s own pledge. Warren’s pledge mandates that Califf won’t work for any company he oversees at the FDA for at least four years after he finishes.

Califf agreed, and signed.

There are still a number of Democrats, however, who have yet to commit to voting for him. Asked if he had decided, Sen. Chris Coons, a Delaware Democrat who is a close ally of Biden’s, told CNN, “No, I have not.”

He is one of more than at least half a dozen Democrats still on the fence.

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