WASHINGTON - The White House is closing in on former Food and Drug Administration commissioner Robert Califf as its choice to serve again as the agency’s leader, according to three 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 national health crisis. Under federal law, President Joe 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. Califf declined a request for comment.
FDA is weighing a series of highly scrutinized decisions, including whether to approve 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.
Califf, a cardiologist, served as FDA commissioner for less than a year at the end of Barack Obama's administration, after being confirmed in an 89-4 vote in February 2016. His confirmation process faced resistance from lawmakers like Sens. Joe Manchin, 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.
He previously served as deputy commissioner of the FDA's Office of Medical Products and Tobacco. He is currently a professor of cardiology at Duke University School of Medicine.
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 that the long-lasting effects of coronavirus will 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 2021.
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 were happy with Woodcock’s leadership and hoped she would stay on, saying the longtime regulator provided a steady hand at a tumultuous time for FDA. While the administration was hoping to find a diverse candidate, officials ultimately landed on a government veteran who knows and understands the agency.