President Joe Biden has officially nominated former Obama administration pick Robert Califf, M.D., as his new FDA commissioner.
This comes right before Nov. 15, the final day Janet Woodcock, M.D., the acting commissioner, can stay in the interim role, and 10 months after Biden’s inauguration.
An FDA veteran, Woodcock has two stints heading up the Center for Drug Evaluation and Research—from 2008 until now and from 1994 to 2005. In between, she served in the FDA commissioner’s office. Most recently she served as part of Operation Warp Speed, overseeing COVID-19 therapy development.
She had initially been seen as a favorite to take the top job on a full-time basis but appeared to lose confidence from some key Washington insiders after the approval of Biogen’s expensive and controversial Alzheimer’s drug Aduhlem.
In announcing Califf's nomination, Biden praised Woodcock for having “worked hard and followed the science to ensure the American public can trust the decisions being made by the FDA.”
RELATED: After Aduhelm fallout, FDA veteran Woodcock out of running for commish job: report
Califf of course is also no stranger to the FDA, heading up the agency as its commissioner for the last year of the Obama era, before being dumped by the Trump administration in early 2017. He has since gone off and made a name for himself in the industry, taking jobs at Verily Life Sciences/Google Health and in 2018, appointed to the board of directors of Cytokinetics.
His roles with biopharma, not unusual for top FDA execs, has already earned the ire of Public Citizen, which urged Biden not to make the “recycled” Califf his official pick.
“Califf must not be allowed to again pass through the revolving door between the FDA and regulated industries,” the lobby group said as the news broke Friday morning, urging the Senate to reject the nomination.
In his announcement, Biden said he's choosing an “independent hand” to guide the agency.
Editor's note: The story has been updated, as President Joe Biden announced Robert Califf's nomination.