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October 18, 2021

Robert Califf is a 'final contender' to lead FDA—again

Daily Briefing

    As acting FDA Commissioner Janet Woodcock nears the end of her term, the White House is considering former FDA commissioner Robert Califf to lead the agency as its first permanent chief since President Joe Biden took office, sources told the New York Times and other media outlets.

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    The deadline to nominate a new commissioner is fast-approaching

    Woodcock will not be able to legally stay on as the acting FDA commissioner after Nov. 15 unless a permanent commissioner has been nominated, CNN reports. It is expected that the White House will name a nominee in the coming weeks.

    Woodcock herself was reportedly under consideration for the role earlier in the process, Politico reports. However, the White House is not likely to select her for the final nomination after several Democrat lawmakers in the Senate indicated they would not support her nomination, citing her handling of opioids and other regulatory decisions. According to the Washington Post, Woodcock was also criticized by other FDA staff for signing a statement that supported coronavirus booster shots before FDA specialistshad fully vetted the plan.

    However, two people familiar with the deliberations told the Post that the White House is considering plans to keep Woodcock in a senior role.

    Califf seems to be the likely nomination 

    The emerging lead for the nomination, according to the Times, is Califf, a cardiologist and professor at Duke University School of Medicine, who previously served as FDA commissioner for less than a year at the end of President Barack Obama's second term. He was confirmed as commissioner by the Senate in an 89-4 vote in February 2016.

    According to a senior federal official who is familiar with the administration's search, Califf's prior confirmation as commissioner made him an appealing candidate because many believe he could successfully complete the confirmation process again.

    In addition, many industry experts and federal officials have shown support for Califf's potential nomination.

    For example, Eric Topol, director of the Scripps Research Translational Institute and a fellow cardiologist who has worked with Califf on research studies, said Califf is "one of the most experienced clinical trialists in the world, and he already had FDA oversight experience." He added that Califf wouldhave "an immediate impact at the agency by pushing forrapid authorization of additional coronavirus tests, shots, and other medical products awaiting review," the Washington Post writes.

    Separately, former FDA Commissioner Mark McClellan told Politico, "Rob Califf would be a strong, experienced and effective commissioner."

    However, although Califf is currently considered the top choice for the nomination by many, he will likely still face opposition from the Senate Democrats who voted against him six years ago—but White House officials reportedly hope to secure his confirmation by gaining several Republican votes.

    Watchdogs are currently reviewing the regulatory decisions Califf made during his first term at FDA—and some believe his industry ties might affect his possible nomination and leadership. "There are plenty of other, highly qualified doctors and leaders who don't bring [Califf's] corporate ties to this most crucial agency," said Jeff Hauser, who leads the Revolving Door Project, part of the Center for Economic and Policy Research, a progressive think tank.

    Still, White House officials are predicting strong support for Califf's nomination, the Post reports, since 65 of the 89 senators who voted to confirm Califf as FDA commissioner in 2016 are still serving in the chamber.

    Among Califf's original supporters is Sen. Patty Murray (D-Wash.), who chairs the Senate Health, Education, Labor and Pensions Committee. "He is a strong nominee for the FDA commissioner," Murray said at Califf's confirmation hearing in 2015, where she highlighted his "impressive history of leadership and management experience."

    Either way, however, even though Califf is seen as a final contender, White House officials as of Thursday said the decision has not yet been made. "There has not been a decision made for the FDA commissioner and we remain grateful to the strong acting leadership at the FDA," a White House official said (Weiland, New York Times, 10/14; Collins/Diamond, CNN, 10/14; Lim et al., Politico, 10/14; Pager et al., Washington Post, 10/14)

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