Woodcock takes charge as acting FDA commissioner

Regulatory NewsRegulatory News | 20 January 2021 |  By 

Janet Woodcock, the long-serving director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), is officially the agency’s acting commissioner and is reportedly being considered for the Biden administration’s permanent pick for the role.
Hours after the presidential inauguration, Woodcock tweeted, “It is an honor and privilege” to serve as acting commissioner. “The FDA’s public health work is more critical than ever as we continue to fight this global pandemic,” she wrote. Both the FDA and HHS leadership webpages have been updated to reflect Woodcock’s acting role.
“This has been a very tough year, and we have a challenging road ahead. I know you all have endured hardships while carrying out our public health mission, balancing work and family, and trying to stay safe. It has not gone unnoticed,” Woodcock wrote in a note to FDA staff.
Woodcock’s tenure at FDA began at the Center for Biologics Evaluation and Research (CBER) in 1986, where she held various division and office director-level roles before being promoted to CDER director in 1994, a position she would hold for the next decade. Woodcock then served in several positions in the Office of the Commissioner from 2004-2008 and simultaneously served as acting CDER director for six months in 2007-2008 before being named CDER director again in March 2008.
Woodcock remained at the head of CDER until last year, when she stepped away to join Operation Warp Speed, and recently returned to the agency as Principal Medical Advisor to then-FDA Commissioner Stephen Hahn.
In her note to staff, Woodcock explained that she will continue in her role in Operation Warp Speed, at least temporarily, to support the development of COVID-19 therapeutics. Woodcock noted that her recusal from FDA decision-making on such products will remain in place, but that her recusal does not extend to vaccines or diagnostics.
“To help with the transition, I’ve been asked to continue some work with the therapeutics development effort. This work will involve government-sponsored research and clinical trials, and other matters that would be appropriate for an FDA employee. I will not be involved in contract discussions or similar matters with individual companies,” she wrote.
Woodcock also said she has asked CBER Chief of Staff Julie Tierney to serve as her acting chief of staff, pending ethics clearance.
Former FDA Commissioner Scott Gottlieb applauded the move to install Woodcock as acting commissioner on Twitter. “In my time at FDA I admired Janet Woodcock for her operational acumen and uncommonly good judgment. She was respected on Capitol Hill for effectiveness and candor. She will represent FDA's prerogatives well in a time of crisis, and advance the interests of consumers and patients,” Gottlieb wrote.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy