The White House is closing in on former Food and Drug Administration commissioner Robert M. Califf as its choice to serve again as agency chief, according to five people who spoke on the condition of anonymity to detail the discussions.
The agency, which has been overseen by acting commissioner Janet Woodcock, has been without a permanent leader for more than eight months during a health crisis that has subjected its decisions to unprecedented scrutiny. Under federal law, President Biden faces a mid-November deadline to either nominate Woodcock or pick an alternate leader for the agency, which plays a central role in regulating vaccines, therapies and other medical products.
A White House official said no final decision has been made, and Biden did not respond to questions after delivering prepared remarks Thursday on his administration’s coronavirus response. Califf, a professor of cardiology at Duke University School of Medicine, declined a request for comment.
FDA is weighing a series of consequential decisions, including whether to authorize coronavirus vaccines for young children, more booster shots for adults and additional treatments to fight the pandemic. The agency also is reviewing potential bans on Juul and other e-cigarette manufacturers and facing a probe into its approval of a controversial Alzheimer’s drug, among other contentious matters.
At the besieged FDA, ‘it never stops!’ as decisions loom on boosters, pediatric shots and more
Califf, a cardiologist, served as FDA commissioner for less than a year at the end of Barack Obama’s presidency, after being confirmed in an 89-4 vote in February 2016. His confirmation process faced resistance from lawmakers like Sens. Joe Manchin III (D-W.Va.) and Bernie Sanders (I-Vt.), who criticized the longtime Duke University researcher’s ties to pharmaceutical companies that helped fund his work and paid him significant consulting fees.
He previously served as deputy commissioner of the FDA’s Office of Medical Products and Tobacco.
Califf, who has advised Google and its spinoff, Verily Life Sciences, since leaving the Obama administration, has also focused on combating chronic disease. He was among the experts who pressed the Biden administration to take more action on the global vaccine response this summer, warning the long-lasting effects of coronavirus is likely to plague the U.S. health system for years to come.
“[O]nce the acute phase of this crisis has passed, we will face an enormous wave of death and disability as a result of common chronic diseases,” Califf wrote in the journal of the American Heart Association in April.
Califf could encounter opposition from the Senate Democrats who voted against him six years ago, including Manchin and Sanders, but White House officials are hoping to secure his confirmation by picking up at least several Republican votes.
While Biden moved quickly to name other senior health care officials, bipartisan lawmakers and public health experts have raised concerns about the delays selecting a full-time FDA commissioner. Some agency officials are happy with Woodcock’s leadership and hoped she would stay on, saying the longtime regulator provided a steady hand at a tumultuous time. But her candidacy drew fire from Manchin, who panned Woodcock’s handling of opioids and other regulatory decisions. Other FDA staff criticized Woodcock for signing on to a statement supporting coronavirus booster shots before FDA’s own vaccine specialists had vetted the plan. The White House has considered plans to retain Woodcock in a senior role, said two people with knowledge of the deliberations.
Although administration officials hoped to find a candidate who reflected Biden’s pledge of a diverse leadership team that includes several women and people of color, the officials ultimately zeroed in on Califf — a government veteran who knows and understands the FDA.
Califf’s likely selection was hailed by prominent health experts like Eric Topol, director of the Scripps Research Translational Institute and a fellow cardiologist who has collaborated on research studies with Califf, and who criticized the FDA in a New York Times op-ed earlier this year for not moving faster to approve vaccines.
“He’s one of the most experienced clinical trialists in the world, and he already had FDA oversight experience,” said Topol, adding that Califf would have an immediate impact at the agency by pushing for rapid authorization of additional coronavirus tests, shots and other medical products awaiting review.
Watchdogs said they were reviewing Califf’s regulatory decisions from his first term at FDA, and some predicted his industry ties would complicate his nomination and possible agency leadership.
“It would obviously improve Verily’s prospects on the markets if everyone knows they have a friend in charge of the agency approving their products,” said Jeff Hauser, who leads the Revolving Door Project, part of the Center for Economic and Policy Research, a progressive think tank. “There are plenty of other, highly qualified doctors and leaders who don’t bring his corporate ties to this most crucial agency.”
On Capitol Hill, lawmakers on Thursday said they had not been briefed on Biden’s nomination plans and would reserve judgment until the selection was finalized. A spokesperson for Manchin, a pivotal swing vote on Biden’s broader agenda, declined to comment.
But White House officials are banking on strong support for Califf’s nomination, including from Republicans. Sixty-five of the 89 senators who originally voted to confirm Califf as FDA commissioner are still serving in the chamber, including Sen. Patty Murray (D-Wash.), who chairs the Senate Health, Education, Labor and Pensions committee. Murray extolled Califf’s qualifications when he was first tapped to lead the agency.
“He is a strong nominee for the FDA commissioner,” Murray said at Califf’s November 2015 confirmation hearing, touting his “impressive history of leadership and management experience.”
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