Biden selected Califf, a renowned cardiologist and researcher who served as the agency’s head during the last year of the Obama administration, to lead the federal agency through a difficult period. The FDA faces heightened scrutiny over its handling of vaccines, coronavirus treatments and rapid tests, along with other controversial products, such as opioids, tobacco and treatments for Alzheimer’s disease.
Although Califf, 70, has deep expertise and experience within the FDA, he has been met with reservations by some Democrats, especially those from states battered by the opioid crisis.
Driven by those concerns, Sens. Maggie Hassan (D-N.H.) and Bernie Sanders (I-Vt.) did not vote to advance Califf’s nomination.
“New Hampshire has been hit especially hard by the substance misuse epidemic and it is imperative that we have a strong FDA Commissioner in place who recognizes the role that the agency’s decisions played in fueling this crisis,” Hassan said in a statement announcing her intent to vote “no.”
At a hearing last month, Califf attempted to assuage those concerns by promising, if confirmed, a review of opioids, including directing the agency to reconsider the drugs’ labels that spell out their use.
Those reassurances did not go far enough for some lawmakers to support Califf’s nomination.
“After careful review of Dr. Califf’s record, including questioning him during last month’s nomination hearing, it does not appear that things would be different under his leadership,” Hassan said.
Califf is widely supported by experts within the FDA who see him as experienced, skilled and likely to support the agency as it continues to navigate the pressures of a pandemic that has brought increased scrutiny and criticism. In December, Califf spelled out his priorities, including fighting misinformation, gathering better data on drugs and medical devices after they have been approved, and working to expand access to rapid coronavirus tests.
“Every family should have a quantity of tests,” Califf told lawmakers in December.
Because a handful of Democrats split from the majority over Califf’s nomination, some Republicans had to vote in favor of his nomination to move it to the full Senate.
Most Democrats and several committee Republicans, including Sens. Richard Burr (N.C.), Susan Collins (Maine), Lisa Murkowski (Alaska) and Mitt Romney (Utah), voted in favor of bringing Califf’s nomination to a vote before the full Senate.
“I’m not sure you could write a résumé for someone who’s more qualified to be FDA commissioner,” Burr said last month when Califf answered questions before the committee.
In 2016, Califf was overwhelmingly confirmed as FDA commissioner by the Senate in an 89-to-4 vote. He is expected to draw enough bipartisan support to be confirmed this year because of his reputation as an expert on health data who is not hostile to drug companies.
But the vote could be tighter than it was in 2016, in part because of Califf’s record on abortion access issues.
Under Califf’s leadership, the FDA loosened some restrictions on mifepristone, one of the two pills used in medication abortions. Then in 2020, the agency temporarily allowed the drug to be prescribed through telemedicine and mailed to patients amid the pandemic. The FDA formally adopted those loosened regulations last month.
The Susan B. Anthony List, an antiabortion advocacy group that keeps a “scorecard” ranking legislators based on their abortion-related positions, announced it would downgrade the score of senators casting votes in favor of Califf’s confirmation. Several other antiabortion groups signed on to a letter opposing Califf’s nomination to lead the FDA. That may dissuade some Republicans from voting to confirm him.