Sens. Bernie Sanders (I., Vt.) and Joe Manchin (D., W.Va.) joined Republicans on Tuesday to oppose President Joe Biden's pick to head the Food and Drug Administration. But the Senate approved the nominee after six Republicans crossed the aisle to confirm him.
The upper chamber voted 50 to 46 to approve Dr. Robert Califf, who will serve as FDA commissioner for a second time after holding the position during the Obama administration from 2016 to 2017. Three Democrats—Sens. Richard Blumenthal (D., Conn.), Maggie Hassan (D., N.H.), and Ed Markey (D., Mass.)—joined Sanders and Manchin to vote against his confirmation. The group of Democrats criticized the Biden pick for his ties to the pharmaceutical industry and failure to effectively regulate opioids during his first stint at the FDA. Republicans, meanwhile, focused on Califf's efforts to deregulate chemical abortion pills, which have four times the complication rate of surgical abortions.
Republican senators Roy Blunt (Mo.), Richard Burr (N.C.), Susan Collins (Maine), Lisa Murkowski (Alaska), Mitt Romney (Utah), and Pat Toomey (Pa.) broke with their party and voted to confirm Califf.
Califf will take over the FDA as the agency focuses on opioid abuse and COVID-19 vaccines. Isolation amid the pandemic has led to skyrocketing drug overdoses, which surpassed 100,000 annually last year for the first time ever.
The FDA under Califf's leadership saw an all-time high in prescription opioid deaths. Manchin said the FDA's failure to effectively restrict opioid access will likely continue as Califf returns to the agency.
"Dr. Califf has shown us who he is, and he has shown a complete lack of interest in actually making the difficult decisions that we need the leader of the FDA to make," Manchin said Monday. "Nothing that Dr. Califf has said or done has led me to believe he will operate the FDA any differently than he did during his previous tenure."
As the founding director of the Duke Clinical Research Institute, Califf was a paid consultant for pharmaceutical companies such as Merck, Johnson & Johnson, GlaxoSmithKline, AstraZeneca, and Eli Lilly. Markey said Tuesday that Califf did not commit to necessary reforms of the pharmaceutical industry to counter opioid abuse.
Until 2016, the FDA required chemical abortion pill providers to report all adverse events, such as hemorrhages and ectopic pregnancies. The FDA under Califf altered its policy so companies were only required to report deaths to the agency.
The agency then cited its adverse events database for the drug to justify its December decision to end the in-person requirement to obtain a prescription. The FDA database does not require emergency rooms to report medical complications for women who take chemical abortion pills. When emergency rooms are taken into account, the rate of medical complications is as much as 10 times higher than in studies that exclude it.
Califf said he was not involved in the December ruling but added that the FDA makes decisions "based on the latest data and scientific principles."
Even though Califf tried to distance himself from the Biden administration's deregulation of abortion pills, Sen. Steve Daines (R., Mont.) said Califf's moves as FDA commissioner helped set the stage for the December decision.
"Califf showed blatant disregard for the unborn and for the health and safety of women and girls when he weakened safety and reporting requirements for a dangerous chemical abortion drug," Daines said prior to the vote.
In recent months, Sanders and Manchin have been bitter rivals within the Democratic caucus. The Vermont senator criticized his West Virginia colleague for refusing to support the multitrillion-dollar Build Back Better plan as well as controversial voting legislation.
The Senate approved Califf in 2016 with an 89-4 vote.