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 White House officials declined to confirm.
In response to questions about whether Biden is prepared to nominate a commissioner, White House Press Secretary Jen Psaki said "not yet." She said, "The president is definitely eager to make a decision about an FDA nominee and make that decision public once it's made."
Another official said: "There has not been a decision made for the FDA commissioner and we remain grateful to the strong acting leadership at the FDA."
Acting Commissioner Janet Woodcock has temporarily shepherded the agency for more than nine months, nearly as long as her confirmed predecessor Stephen Hahn. 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.
Califf oversaw FDA during the controversial approval of the drug eteplirsen under an accelerated approval pathway under heavy pressure from patient advocates eager for a treatment for the rare disease Duchenne muscular dystrophy. FDA leaders like Woodcock overruled the agency's career scientists , who argued the data were insufficient.
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 soon whether to approve booster shots for Moderna and Johnson & Johnson COVID-19 vaccine recipients, 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.
Niels Lesniewski contributed to this report.