Feb. 7, 2022 – Although the nomination of Dr. Robert Califf to return as FDA Commissioner was advanced by the Senate House, Education, Labor, and Pensions (HELP) Committee just weeks ago and it appeared Califf was poised to be confirmed by the full Senate, new opposition to his nomination reportedly has switched at least some Republican votes from “Yes” to “No,” and the Senate vote has been delayed while Califf’s supporters scramble to lock down the 50 votes they need for confirmation.
“Senate Majority Leader Chuck Schumer [D-N.Y.] says he will delay scheduling the confirmation vote until he sees the votes to confirm,” Coalition for Healthcare Communication Executive Director Jon Bigelow said in a CHC Industry Leaders Alert on Feb. 3. “My guess is that Califf will ultimately be confirmed, but this is not a done deal.”
It was understood from the start that Califf would lose the votes of a small number of Democratic senators based on a mix of concerns that Califf did not take strong enough measures on opioid medications during his first term as Commissioner, and that he had close ties to industry – working on clinical trials, serving on boards and holding investments – either before his prior FDA tenure and since leaving the FDA.
Indeed, at least four Democratic senators have announced they will vote No: Sens. Maggie Hassan (D-N.H.), Joe Manchin (D-W. Va.), Ed Markey (D-Mass.), and Bernie Sanders (I-Vt.); a fifth, Richard Blumenthal (D-Conn.), has expressed strong reservations. According to the STAT health news service, at least 10 Democratic senators have not yet committed to voting for Califf and have expressed various concerns.
Given that opposition at least a few Republican votes are needed, and “initially, the chances looked good, seeing as Califf was confirmed in 2016 in an 89-4 vote, and 65 of those Yes voters are still serving in the Senate,” Bigelow stated. Right after his Dec. 14 HELP Committee hearing, several Republicans stated they would vote in favor – including ranking member Sens. Richard Burr (R-N.C.) and Roger Marshall (R-Kan.) and Tommy Tuberville (R-Ala.) – and others seemed winnable.
However, two days after the committee hearing, the FDA issued a decision allowing patients to receive mifepristone, used for abortions, by mail following telemedicine visits. Antiabortion groups then launched a strong lobbying effort with Republican senators targeting Califf based on his positions on abortion drugs, Bigelow explained.
By the time the HELP Committee voted to advance the nomination to the floor, Marshall and Tuberville switched to No votes. Since then, several other Republican senators have announced they will oppose Califf. And the Republicans on the HELP Committee who voted Yes—Sens. Susan Collins (Maine), Lisa Murkowski (Alaska), and Mitt Romney (Utah)—are being pressed to oppose Califf on the final vote.
Some Califf supporters have alleged that the Biden administration has not been doing enough to support the nominee; White House officials now are actively canvassing for votes and the chair and ranking member of the HELP Committee, Sens. Patty Murray (D-Wash.) and Burr, are trying to secure votes among their two parties.
Califf is continuing to meet one-on-one with senators, reportedly having held or scheduled 47 such meetings to date. Last week he also committed to going beyond the Biden administration’s ethics guidelines by recusing himself from FDA decisions involving companies with which he has been involved, and promising to forgo financial ties with companies involved in FDA decisions for at least four years following the end of his new service as FDA Commissioner; so far, this has won over at least one new supporter, Sen. Elizabeth Warren (D-Mass.). He also appears to have won the vote of Sen. Ron Wyden (D-Ore.) with a promise to take a tough stance against companies that win drug approvals through the accelerated pathway but then do not promptly do follow-up studies.
Recent reporting suggests that Califf would definitely lose five Democratic votes and that at least 10 others remain uncommitted. Meanwhile, one Republican (Burr) is firmly in favor and perhaps eight others are believed winnable.
And if Califf does not get confirmed? “Dr. Janet Woodcock could remain Acting Commissioner for up to seven additional months, but the same factors driving opposition to Califf would doom her candidacy for the permanent role” according to Bigelow. “It is unclear who would be nominated by Biden with a better chance of confirmation than Califf.”
To learn more about this nomination and Biden’s 2022 legislative and regulatory priorities in health policy, sign up today for Prevision Policy Senior Editor Kate Rawson’s take on the healthcare scene in Washington. She will speak, and answer your questions, at a CHC webinar on Tues., Feb. 15, from 12 pm to 1 pm ET. Tuition: Only $65 (for staff of Coalition member companies, identified here) or $80 (from non-member companies). Click here to register.