FDA nominee meets unexpected hurdles

President Biden's pick to lead the Food and Drug Administration (FDA) is facing surprising headwinds, as Senate Democrats work to build up enough bipartisan support for confirmation.

More than two months after being nominated, it's unclear if Robert Califf has enough votes to be confirmed. At least five Democrats have already spoken out against him, and others remain undecided.

At the same time, Republicans are facing pressure from anti-abortion groups, which have mobilized against Califf. He gained just four GOP votes in a committee vote last month.

Califf, a cardiologist and Duke University researcher, was confirmed to the same post by a vote of 89-4 in 2016 when he was nominated by former President Obama, so the opposition this time is unexpected.

Some Democrats said they are still confident Califf will get 50 votes, but there are concerns about extra drama during a process that was supposed to be fairly smooth.

"I think he'll have the votes. But it's going to be an interesting mix of Republicans and Democrats," said Sen. Chris Murphy (D-Conn.).

Sen. Dick Durbin (Ill.), the No. 2 Senate Democrat, said the votes were "very close."

The FDA is one of the primary agencies helping shape the nation's response to the global COVID-19 pandemic that has killed more than 880,000 Americans. It regulates products like masks, lab tests and vaccines, but is also responsible for the nation's food supply.

The agency is being run in an acting capacity by Janet Woodcock, a career FDA official who previously was in charge of the agency's drug evaluation unit. Woodcock's tenure was limited by federal law, and Biden waited until almost the last minute to name a nominee.

The White House for months deflected questions about the delay in nominating a Senate-confirmed FDA commissioner, saying it wanted to be sure whoever they chose could get majority support in the chamber.

Officials have said they still believe Califf can earn bipartisan support to offset the Democratic defectors, pointing to his last confirmation hearing and his broad experience as a doctor and researcher.

Four Democrats - Sens. Joe Manchin (W.Va.), Ed Markey (Mass.), Maggie Hassan (N.H.) and Richard Blumenthal (Conn.) - as well as Sen. Bernie Sanders (I-Vt.) have signaled opposition to Califf's nomination over his ties to industry and the FDA's role in the opioid crisis.

Since he left government, Califf has advised Google Health and its spinoff, Verily Life Sciences, where he was paid millions in stock and more than $2.7 million in salary and bonuses.

Sen. Ron Wyden (D-Ore.) told reporters Tuesday that he had a "productive" call with Califf on Monday, but has not made a decision yet and has more follow-up questions. Wyden noted White House staff were on the call as well, and said he asked Califf about "how he would, at FDA, hold the big pharmaceutical companies accountable."

On the Republican side, anti-abortion groups have been lobbying hard against Califf. The Susan B. Anthony List said it would "key vote" Califf's nomination as a result of his work on the abortion drug mifepristone during the Obama administration.

Nearly all Republican senators have an A+ from the organization, with the exceptions of Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska). Collins and Murkowski joined with Sens. Mitt Romney (Utah) and Richard Burr (N.C.) as the only Republicans to vote for Califf in committee.

Burr, who is the top Republican on the Senate Health Committee, said he knows his colleagues are feeling pressure from anti-abortion groups worried about increased access to mifepristone.

"I like him," Burr said of Califf. "I think he'll be confirmed. The overall concern is from the pro-life community, which Dr. Califf wasn't there when this decision was made, so I'm not sure why they're so irate."

Senior White House officials are making bipartisan calls to senators asking for support.

A White House official said Califf has met with 33 senators so far, and is scheduled to meet with at least 14 more. Of those meetings, 26 are with Democrats and 21 with Republicans.

"We are working hard and HHS is working hard every day to get Dr. Califf nominated. We believe it is extremely important to have a confirmed head of the FDA in the midst of the pandemic," the White House said.

Marc Scheineson, a partner at Alston & Bird who served as associate commissioner for legislative affairs under former FDA Commissioner David Kessler, said he thinks the administration underestimated the difficulty of Califf's nomination.

"I think they're surprised. I think they have a lot more work to do. And they really didn't want to invest their limited resources in something that they thought was pretty easy," Scheineson said. "I think they thought this was a bit of a slam dunk ... I think that's why they selected [Califf]."