Biden's FDA Nominee Faces Confirmation Trouble

Robert Califf’s nomination to lead the FDA could be in serious trouble. Sources in Congress have told Politico that the former FDA commissioner doesn’t currently have the votes to be confirmed by the Senate a second time.

Califf, who previously served as FDA commissioner during President Barack Obama’s last year in office, entered the current nomination process with significant existing Democratic opposition. Five Democratic senators—Bernie Sanders, Maggie Hassan, Joe Manchin, Richard Blumenthal, and Edward Markey—have indicated they will vote against the nominee, based mostly on disputes over the FDA’s handling of the opioid crisis and Califf’s connections to the drug industry.

Two weeks ago, Califf cleared a vote on the Senate Health, Education, Labor and Pensions (HELP) Committee by a 13-8 margin, as six Republicans joined Democrats Sanders and Hassan to vote against the nominee. The vote was closer than expected, with just four Republicans supporting Califf. But those four votes may be all the nominee can count on in the full Senate vote, according to a Republican lobbyist who spoke to Politico.

Republican support crashed when the FDA eased restrictions in December on mailing abortion medication prescriptions obtained through telehealth appointments. Since then, pressure on Republican Senators from anti-abortion groups has turned the nomination from a likely bipartisan romp into a quagmire for the Biden administration.

The Senate opposition has nothing to do with FDA vaping regulation, but supporters of liberalizing vaping product standards are quietly cheering Califf’s nomination problems. Vaping advocates, who generally oppose Califf’s nomination, believe the former Duke University cardiology researcher would encourage the FDA Center for Tobacco Products (CTP) to lean toward harsh regulation of vaping products.

The agency is currently paralyzed by indecision over authorizing more e-cigarettes for market, and has been challenged in court by more than two dozen manufacturers whose Premarket Tobacco Applications (PMTAs) have received Marketing Denial Orders (MDOs). After more than a year reviewing applications, the CTP has authorized just one product: a primitive, tobacco-flavored e-cigarette. Most flavored products have received MDOs, using a standard that was sprung on manufacturers after the fact.

The next FDA commissioner will likely take an active role in guiding the CTP process, especially since the tobacco office will have a new director soon. Acting Commissioner Janet Woodcock has shown little interest in, or knowledge of, the tobacco end of the FDA's responsibilities. If the Califf nomination crumbles, Woodcock will also be forced to lead the choice of a new CTP director to replace Mitch Zeller, who has announced he will retire in April.