Senate confirms Biden FDA nominee

The Food and Drug Administration (FDA) has a new permanent leader for the first time in over a year after the Senate on Tuesday voted to confirm Robert Califf.

Califf was confirmed in a vote of 50-46, with Sen. Mike Rounds (R-S.D.) voting “present.” Rounds “paired” his vote to offset the absence of Sen. Ben Ray Luján (D-N.M.), who is recovering after suffering a stroke.

The close vote reflected unexpected opposition from both Democrats and Republicans, as the nomination was roiled with debate about abortion and opioids. 

Democratic Sens. Joe Manchin (W.Va.), Ed Markey (Mass.), Richard Blumenthal (Conn.) and Maggie Hassan (N.H.), and Independent Sen. Bernie Sanders (Vt.), who caucuses with Democrats, voted against him, as well as almost all Republicans.

Democrats were critical of Califf’s ties to the pharmaceutical industry, as well as the FDA’s record on opioid approvals.

The razor-thin margin was evident Monday, when Democrats were able to shut down debate on the nomination, 49-45, because five Republicans were missing from the vote. 

Ultimately, Califf picked up six Republicans on Tuesday to balance out the Democratic defections: Sens. Roy Blunt (Mo.), Richard Burr (N.C.), Susan Collins (Maine), Lisa Murkowski (Alaska), Mitt Romney (Utah) and Patrick Toomey (Pa.).

Califf is a “supremely qualified nominee with bipartisan support,” Burr said prior to the vote. “The FDA has an opportunity to be forever changed for the better, but it needs effective leadership to get there.” 

Califf had slowly been picking up Democratic votes leading up to the vote by making individual pledges to lawmakers, including Sens. Dick Durbin (Ill.), the No. 2 Senate Democrat, Elizabeth Warren (Mass.) and Senate Finance Committee Chairman Ron Wyden (Ore.). 

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. He was widely viewed as a shoo-in for the position this time. 

As a result, the pushback appeared to catch the White House by surprise, and the nomination had been stalled since November. Officials engaged in an intense behind-the-scenes effort to shore up the votes for Califf, as conservatives tried to galvanize a handful of expected Democratic “no” votes and sink his confirmation. 

Republicans faced pressure from anti-abortion groups, which have mobilized against Califf. He gained just four GOP votes in a committee vote last month.

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.

Califf has “a track record of putting an extreme agenda before the science,” Sen. Steve Daines (R-Mont.) said prior to the vote. 

FDA has been without a confirmed leader for nearly 400 days.

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.

Updated at 1:33 p.m.