WASHINGTON — President Joe Biden is considering a plan to nominate former Food and Drug Administration Commissioner Robert Califf to take the reins of the agency as its permanent leader, according to a news report.
If chosen and confirmed by the Senate, the Obama-era government official would take the helm at a time of intense public scrutiny. Throughout the COVID-19 pandemic, the FDA’s decisions have faced scrutiny as its regulators have made crucial decisions over booster shots and pediatric vaccinations.
In 2016, the Senate overwhelmingly confirmed Califf’s nomination, 89-4. Though he served as FDA commissioner for less than a year, his history of bipartisan approval and long track record with the agency could help grease the wheels of his confirmation process.
The Washington Post first reported the move, which a White House official declined to confirm.
“There has not been a decision made for the FDA commissioner and we remain grateful to the strong acting leadership at the FDA,” said the official.
Acting Commissioner Janet Woodcock has temporarily shepherded the agency for more than nine months, nearly as long as Stephen Hahn, her confirmed predecessor. But her tenure as acting administrator expires on Nov. 15. Woodcock can remain in place as long as it takes for her successor to be confirmed.
Califf, a cardiologist, had such strong bipartisan support that when President Donald Trump took office in early 2017, many pharmaceutical and medical device industry officials expressed hope he would continue on as the FDA’s leader.
Sens. Joe Manchin III, D-W.Va., and Edward J. Markey, D-Mass., both opposed Califf’s confirmation in 2016 and argued that Califf was unlikely to make changes at the agency to reduce access to opioid painkillers.
Similar concerns, and Biden’s reluctance to publicly split Senate Democrats, reportedly hobbled Woodcock’s nomination to the permanent post.
But the majority of sitting senators, including the current Senate Health, Education, Labor and Pensions Committee Chairwoman Patty Murray, D-Wash., and Senate Minority Leader Mitch McConnell praised Califf’s leadership experience and regulatory know-how in 2016.
In addition to his experience at the FDA, Califf professionally advised several pharmaceutical companies throughout his career, including Johnson & Johnson, GlaxoSmithKline, AstraZeneca and Eli Lilly.
Former FDA Commissioner Mark McClellan, who also currently advises drug companies, said Califf’s understanding of the agency would be helpful.
“He has experience in leading the FDA, so he knows the agency and how to build on its strengths and address challenges, as well as to lead the agency in taking effective action,” said McClellan, director of the Duke-Margolis Center for Health.
Califf would face a daunting agenda, if nominated and confirmed.
After the agency determines whether to approve booster shots for Johnson & Johnson COVID-19 vaccine recipients (it backed boosters for some Moderna recipients on Thursday), the FDA will also scrutinize whether to approve COVID-19 vaccines for children ages 5-11.
The agency faces other challenges in the coming months, including grappling with an inspector general’s investigation of its approval of the controversial Alzheimer’s drug Aduhelm, which could shape the agency’s drug approvals for years, and whether to sweep Juul’s e-cigarettes from shelves.
The FDA works closely with the National Institutes of Health. NIH Director Francis Collins also announced earlier this month that he plans to step down from the top position by the end of the year and focus on research.
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(Niels Lesniewski contributed to this report.)
