New FDA chief set to be nominated by Biden, 9 months into his tenure

FDA Building 2
After nine months of leadership from placeholder Janet Woodcock, the FDA may finally have a permanent nominee for the post. (FDA)

After nearly nine months without a permanent FDA leader and after watching the agency withstand a torrent of criticism, President Joe Biden finally is ready—almost—to announce a nominee for the beleaguered agency.

Speaking to reporters on Tuesday in response to NIH Director Francis Collins’ retirement announcement, Biden said in reference to the FDA post, “We’ll be talking about that in a little bit.”

Collins’ departure has accelerated Biden’s selection, a source told Politico.

Since Biden took office, the FDA has been guided by acting commissioner Janet Woodcock. Not having a permanent leader during a particularly challenging period for the agency has frustrated its rank-and-file, sources told NPR last month.

With Woodcock’s tenure required by law to end in the middle of November, Biden had to name a successor soon anyway.

RELATED: Key senator calls for Woodcock's removal as FDA fallout from Biogen Alzheimer's approval heats up

Laurie Glimcher, the CEO of the Dana-Farber Cancer Institute, was once considered the frontrunner for the job. But Glimcher, who also serves on the board of directors at GlaxoSmithKline, told Endpoints that she is not a candidate.

Woodcock remains a candidate despite her stormy tenure and criticism from Sen. Joe Manchin (D-W.Va.), who called for her resignation in June over the agency’s approval of Biogen’s Alzheimer’s disease treatment Aduhelm.

Also thought to be in the running for the FDA job are Joshua Sharfstein, the vice dean for public health practice and community engagement at Johns Hopkins’ Bloomberg School of Public Health, and Michelle McMurry-Heath, the CEO of the Biotechnology Innovation Organization, Politico said.

RELATED: Biden expands his list of potential nominees to lead FDA as pressure mounts to make a pick: WSJ

Another often-named candidate is Eric Topol, the director of the Scripps Research Translational Institute, though he has said he’s not interested in the job.  

As pressure has been applied on Biden for several months to find a replacement, many other prominent names have emerged including Harvard professor Aaron Kesselheim, who recently resigned from the FDA’s advisory committee over the approval of Aduhelm; former Merck CEO Ken Frazier, former FDA commissioner Scott Gottlieb and former FDA officials Luciana Borio and John Jenkins.