Califf Wins Narrow Senate Vote for Second Turn as FDA Commissioner

Robert Califf, MD, received Senate approval today to become FDA commissioner in a 50-46 vote, in which 6 Republicans supported him and 5 Democrats voted against his confirmation.

According to The New York Times, 1 senator who has been opposed to the nomination instead voted “present,” out of deference to colleague, Senator Ben Ray Lujan of New Mexico, who is recovering from a stroke.

Califf, a highly cited cardiologist and a founder of the Duke Clinical Research Institute, has recently served as a senior advisor to Verily and Google Health. He led the FDA during the final 11 months of the Obama administration, but his path confirmation this time has been rocky since he was nominated in November 2021. As recently as Friday, Senator Joe Manchin, D-West Virginia, authored an opinion column calling on Biden to withdraw Califf’s nomination. Manchin castigated Califf’s ties to the pharmaceutical industry and the FDA’s approval of 5 new opioids during his previous tenure as commissioner.

Joining Manchin in voting against Califf were fellow Democrats Senators Richard Blumenthal of Connecticut; Maggie Hassan of New Hampshire, and Ed Markey of Massachusetts, along with Bernie Sanders, I-Vermont.

Califf’s nomination also drew opposition from most Republicans, including antiabortion advocates who scrutinized his record on easing access to abortion medications. However, 6 Republican senators voted to confirm Califf’s nomination: Roy Blunt of Missouri, Richard Burr of North Carolina, Susan Collins of Maine, Lisa Murkowski of Alaska, Mitt Romney of Utah, and Pat Toomey of Pennsylvania.

The FDA has lacked a permanent, Senate-confirmed commissioner since Stephen Hahn, MD, left the role on President Donald Trump’s last day in office. Long-serving FDA official Janet Woodcock, MD, had been acting as commissioner for more than a year, but her tenure brought controversy, notably the approval aducanumab (Aduhelm) for Alzheimer disease. Woodcock had called for an independent investigation of the administration’s actions in its relationship with the manufacturer, Biogen.

In addition, Califf will need to guide the FDA through the ongoing COVID-19 pandemic—including the decision on whether to authorize a vaccine for children under 5 years—and a host of other pressing issues, including e-cigarette marketing applications.

In an opinion piece published today in The Hill, 3 former FDA commissioners and a former CMS official urged the Senate to confirm Califf, writing that "it is long past time to have confirmed leadership at the FDA." Former commissioners Scott Gottlieb, MD, and Mark McClellan, MD—who served in Republican administrations—along with Obama administration veterans Margaret Hamburg, MD; and Andy Slavitt, former acting CMS administrator and member of President Biden's COVID-19 response team last year, said that Califf can "hit the ground running" to deal with the country's urgent, unmet health needs.

The Association for Accessible Medicines (AAM) had previously announced support for Califf when Biden announced the nomination in November, saying the group and its member companies “stand ready to work with Dr Califf and the entire FDA team to ensure America’s patients have timely access to safe, effective and quality generic and biosimilar medicines.”