Woodcock Elevated to Commissioner’s Office as Advisor
Former CDER director Janet Woodcock, who has been on detail at the White House’s Operation Warp Speed (OWS), has moved to the Office of Commissioner to serve as principal medical advisor to the commissioner while also continuing her role with OWS. The move came at commissioner Stephen Hahn’s request, an FDA spokesperson told FDA Webview 1/6.
Woodcock’s new role will include working with deputy commissioner for medical and scientific affairs Anand Shah to advance FDA’s Covid-19 Pandemic Recovery Preparedness Plan, the spokesperson said. Woodcock will continue to recuse herself from participating in any regulatory decision-making regarding specific Covid-19 therapeutics, including decision-making about therapeutics within the agency’s Coronavirus Treatment Acceleration Program. FDA’s regulatory decisions are independent from OWS activities and are governed by the agency’s statutory and regulatory standards.
Under Operation Warp Speed, Woodcock has been focused on therapeutics, particularly antiviral compounds and monoclonal antibody therapies. She is also working with sponsors and NIH on master protocols as a means to test multiple agents. Master protocols are a pet project with Woodcock, who has been advocating for these for many years. In 2017, she and another FDA official authored a New England Journal of Medicine article, saying the move to such protocols is needed because the “standard approach to generating this evidence — a series of clinical trials, each investigating one or two interventions in a single disease — has become ever more expensive and challenging to execute.”
Late last year, Woodcock reflected on the deterioration of the U.S. clinical trials system during the pandemic (see story). Addressing a Friends of Cancer Research program, she said that once the pandemic emergency is over, the agency will “need to do some serious soul searching” and described the current situation with Covid-19 trials as “starvation in the midst of plenty.” She said there is competition for patients at major medical centers and “yet people are sick and dying all over country and they have no access to clinical trials.” FDA is also concerned that there are many trials not yielding actionable data, with an estimated six percent of current Covid-19 trials yielding actionable data, she said. “We need to think about how we can have a more robust standardized process in U.S. for gathering clinical evidence,” Woodcock told the program.