Janet Woodcock to lead FDA as acting commissioner
Longtime drug regulator Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration, has been tapped by the Biden administration to lead the agency as its acting commissioner. Her move into the top spot reportedly follows the resignation of Dr. Stephen Hahn, who had led the agency since early last year, and she mad the announcement in a recent series of Tweets.
Woodcock also posted a letter that she penned to her colleagues, stating that she has been working with the previous Administration’s Operation Warp Speed over the past nine months, on development of certain therapeutics for COVID-19.
“During that time, although not legally required, I’ve been recused from involvement in any agency decision making regarding these products, and those recusals will still be in place. They do 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 contact discussions or similar matters with individual companies," said Woodcock.
Woodcock also noted that the FDA’s public health work is more critical than ever as we continue to fight this global pandemic.
Woodcock joined FDA in 1986. In 2015, she also operated in the role of Acting Director of CDER’s Office of Pharmaceutical Quality. Woodcock first joined CDER in 1994. From 2005 until 2008, she served in the FDA’s Commissioner’s office, holding several positions, as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer.
Her responsibilities encompassed oversight of various aspects of scientific and medical regulatory operations. Before joining CDER, Woodcock served as Director, Office of Therapeutics Research and Review, and Acting Deputy Director in FDA’s Center for Biologics Evaluation and Research.
She received her M.D. from Northwestern Medical School. Prior to that, she completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco.
Woodcock also announced that 12-year FDA veteran Julia Tierney has agreed to serve as her acting chief of staff, subject to ethics clearance.