Senate Narrowly Confirms Dr Robert Califf as FDA Commissioner

The Senate voted 50-46 to confirm Robert Califf, MD, as commissioner of the FDA, which has been without a permanent leader for more than a year.

Robert Califf, MD, was confirmed as FDA commissioner in a 50-46 Senate vote in which 6 Republicans supported him and 5 Democrats voted against his confirmation. According to The New York Times, 1 senator voted “present.”

Califf had previously led the FDA from February 2016 until January 2017, but his path to retake the commissioner’s seat has been met with opposition since his nomination by President Joe Biden last fall. As recently as last 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.

Manchin’s vote against Califf was joined by Senators Richard Blumenthal, D-Connecticut; Maggie Hassan, D-New Hampshire; Ed Markey, D-Massachusetts; and Bernie Sanders, I-Vermont.

Califf’s nomination also drew opposition from some on the other side of the aisle, as antiabortion advocates 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. Janet Woodcock, MD, had been acting as commissioner for more than a year, but her tenure engendered some controversy, including the FDA’s approval of 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; Margaret Hamburg, MD; Mark McClellan, MD; and Andy Slavitt, former acting CMS administrator and member of President Biden's COVID-19 resonse team last year, said he can "hit the ground running" to deal with the country's urgent, unmet health needs.

AHIP congratulated Califf's confirmation and noted the importance of his experience as leader of the FDA.

"This agency plays an essential role in safeguarding the health and well-being of Americans, including their access to effective and safe medications and devices," Matt Eyles, president and CEO of AHIP, said in a statement. "As new drugs come to market, including biologics that represent a new frontier for treatment and cures, the FDA will play an important role in analyzing clinical evidence and ensuring that drug manufacturers bring to market medicines that are proven to work. AHIP looks forward to working with Dr. Califf and the FDA to ensure that every American has access to the affordable, safe, and effective medications they need and deserve.”

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