‘The White House isn’t supporting him’: Biden’s FDA pick left in limbo

President Joe Biden’s nominee to lead the Food and Drug Administration does not yet have the votes in the Senate needed to give the agency its first political leader in more than a year.

More than two months after picking Robert Califf to be FDA commissioner, the confirmation is stymied by Democratic skepticism of the longtime cardiologist’s regulatory track record and a new GOP push to kill his nomination.

The difficulties have sparked deep frustration among top Democrats and touched off a round of finger pointing, with Califf allies privately blaming the White House for doing too little to shore up support for its own nominee, according to two people with knowledge of the matter, who requested anonymity to describe the internal dynamics.

Now, Califf’s supporters fear his candidacy is on the brink — raising the threat of a setback for Biden and the health agency at the center of his pandemic response. The White House, meanwhile, is calling into service some of its top advisers, including Anthony Fauci, to try and rescue the nomination.

Just four Republicans — Sens. Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska and Mitt Romney of Utah — voted for him in committee earlier this month, marking the first public sign of trouble for Califf. In recent days, people familiar with the process have become increasingly concerned about the status of Califf’s nomination.

“If the vote were held today, he would not have the votes,” said one person with knowledge of the matter.

The growing anxiety comes amid a yearlong absence of permanent political leadership at the FDA, after the White House struggled for months to find a candidate who could win majority support in the evenly divided Senate.

As a result, FDA — which regulates everything from Covid-19 vaccines to vast swaths of the nation’s food supply — remains reliant on longtime drug regulator Janet Woodcock to run the agency on an acting basis during a global pandemic that has already killed more than 873,000 people in the United States.

Biden settled on Califf in November, with aides touting his deep government experience and broad appeal — evidenced when he was confirmed to the top FDA post in an 89-4 vote in 2016.

Yet while the administration and lawmakers anticipated narrower margins this time around, the amount of opposition to Califf’s nomination among both Democrats and Republicans is stiffer than they expected, according to interviews with nine people familiar with the confirmation effort.

Califf did not respond to a request for comment.

Five Democrats — Sens. Bernie Sanders (I-Vt.), Joe Manchin (D-W.Va.), Ed Markey (D-Mass.), Maggie Hassan (D-N.H.) and Richard Blumenthal (D-Conn.) — have signaled opposition to Califf’s nomination, but even more remain on the fence, according to four of the people familiar with their thinking.

“I’m surprised the whip on Democrats is as high as they are assuming,” a congressional aide said of the administration’s confidence. “If his meetings have gone as I’ve heard with other Democrats, he’s not making a great impression.”

In recent weeks, Sens. Patty Murray (D-Wash.) and Burr have led a scramble to win last-minute support for Califf, in hopes of holding a floor vote by early February. A HELP Committee aide said Murray “hopes he can be confirmed as quickly as possible.” Some officials and allies remain optimistic they’ll ultimately secure the 50 senators needed to push Califf over the line, contending they only need to win over a few holdouts.

So far, there has been no serious talk of pulling Califf’s nomination, and the administration has no ready fallback candidates. If needed, Senate Democrats could postpone a confirmation vote for weeks while they try to build enough support.

Some close to the confirmation effort argued that Califf’s candidacy never should have been endangered in the first place, faulting the White House for being too detached and noting the nominee himself has struggled to make his case to skeptical senators.

A team from the health department has largely managed Califf’s outreach, to middling reviews, three of the nine people with knowledge of the matter said. Top White House officials, meanwhile, remained largely disengaged even as the administration telegraphed public confidence — and despite internal warnings that the nomination could be in trouble.

“The White House isn’t supporting him,” one of the people with knowledge of the matter said. “He’s kind of his own one-man PR show.”

A White House official disputed the characterization, insisting there’s been “consistent outreach to members throughout this entire process.”

But the White House has over the last few weeks seemed to better understand the peril, one of the people with knowledge of the matter said, dispatching senior aides like chief medical adviser Anthony Fauci, Covid-19 coordinator Jeff Zients and White House staff secretary Neera Tanden to make calls on Califf’s behalf.

“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 spokesperson Chris Meagher said.

Some lawmakers have cited concern about Califf’s work in the private sector after his last stint at FDA. He most recently led health strategy and policy at Alphabet, Google’s parent company, where financial disclosures show he was paid millions in stock and more than $2.7 million in salary and bonuses. The clinical trial expert also must divest holdings in health care companies including Amgen, Gilead Sciences, Bristol Myers Squibb and Walgreens Boots Alliance.

Senators have also expressed concern about Califf’s pharmaceutical industry ties and FDA’s track record regulating opioids.

Meanwhile, few Republicans have publicly backed Califf despite vocal support from Burr, the Senate health committee’s top Republican, who’s retiring at the end of the year. Burr has tried for weeks to secure enough Republican votes to offset the expected Democratic losses, three people with knowledge of the matter said.

Califf also failed to impress some key senators in his one-on-one meetings with them, three of the people with knowledge of the matter said. Pandemic precautions forced Califf to meet with some senators virtually, further complicating the get-to-know-you process critical to winning votes.

A Democratic aide whose boss supports Califf said the senator met with him virtually, but the nominee still wore a mask because he had staff with him.

“It’s just harder to make a connection that way,” the aide said.

Several GOP lawmakers have cited FDA’s recent decision to loosen abortion pill dispensing requirements as reason to oppose the cardiologist. One GOP lobbyist told POLITICO support among Republicans cratered when the FDA moved forward in December with a plan to allow patients to obtain a mailed prescription for mifepristone — an abortion medication — through a telehealth appointment.

“At most, he gets three to four GOP votes, so maybe he is short considering at least five Democrats are a no,” the lobbyist said.

Most Senate HELP Committee Republicans appeared favorable toward Califf during his confirmation hearing in December, based on their lines of questioning and comments to POLITICO afterwards. But at least two — Alabama’s Tommy Tuberville and Kansas’ Roger Marshall — signaled they were swayed by FDA’s mifepristone decision.

Dozens of anti-abortion-rights groups, like Susan B. Anthony List and Students for Life Action, have mobilized against Califf, flooding Senate offices with letters and calls urging “no” votes. They plan to continue lobbying senators when they come back into session this week, setting up meetings with members and staff.

Some of the groups publicly targeted Romney Thursday over his vote to support Califf in committee, arguing that the vote violated his professed anti-abortion views.

Spokespeople for Senate Minority Leader Mitch McConnell declined to answer questions regarding the whip count for Califf or whether he planned to vote to confirm the former FDA commissioner.

Senate Majority Leader Chuck Schumer’s office did not respond to a request for comment.

Several groups, as well as six former FDA leaders, have urged senators to promptly approve Califf, arguing it is critical the agency has permanent leadership during the Covid-19 pandemic.

And major industry organizations, including AdvaMed and the Association for Accessible Medicines, issued positive statements when Califf was nominated.

“Any time you’re without a leader, I think the vision suffers,” AdvaMed CEO Scott Whitaker told POLITICO. “The other thing that always worries me about leaving an agency leaderless for a long period of time is the ability to recruit and attract people to come in and join an agency like the FDA.”

But not every industry regulated by FDA wants Califf to be confirmed. Should Califf retake the mantle in Silver Spring, he’ll be in prime position to speed up regulatory changes that e-cigarette proponents oppose.

“When you’re facing prohibition, delays of execution are never a bad thing,” said Gregory Conley, president of the American Vaping Association.

Alston & Bird attorney Marc Scheineson, who served as associate commissioner for legislative affairs under former FDA Commissioner David Kessler, said it is premature to conclude Califf doesn’t have the votes to be confirmed.

“I think the White House gets the idea this is a priority for them, and between their leverage and Burr’s, the dynamics are good,” Scheineson said. “I’ve heard this will be scheduled or is being considered for the first week of February — obviously, that scheduling depends on having the votes.”

Alice Miranda Ollstein and Katherine Ellen Foley contributed to this report.