Woodcock Likely Acting Commissioner After Inauguration
Former CDER director Janet Woodcock, who had been on detail at the White House’s Operation Warp Speed but recently moved to the Office of Commissioner (OC) to serve as principal medical advisor to the commissioner, is the likely choice of the incoming Biden Administration to serve as acting commissioner after the inauguration next week. Woodcock’s new role at OC was to work with deputy commissioner for medical and scientific affairs Anand Shah to advance FDA’s Covid-19 Pandemic Recovery Preparedness Plan, a spokesperson said. However, Shah has submitted his resignation that is effective just before the inauguration.
Woodcock reportedly is also on the short list of candidates for FDA commissioner, joining former FDA principal deputy commissioner Joshua Sharfstein (see earlier story), according to a Bloomberg News report. Sharfstein is the current vice dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health. He too has been a vocal critic of the Trump Administration’s assault on science. During his time at the agency, he was instrumental in advancing transparency in its regulatory decision making, but that stalled after he left FDA. He recently wrote that “Public confidence in FDA during the Covid-19 pandemic would be improved with greater transparency of the data and the reasoning on which it bases these and other complicated decisions.”
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.