Dive Brief:
- Janet Woodcock, head of the Food and Drug Administration’s drug review division, will serve as acting commissioner of the agency while President Joseph Biden decides on a permanent chief. She is one of several current and former high-ranking FDA officials believed to be under consideration for the permanent job.
- Detailed last year to the former Trump administration’s coronavirus response team, Operation Warp Speed, Woodcock will recuse herself from FDA decisions involving certain COVID-19 drugs that she assisted in development. That recusal will not apply to vaccines or diagnostics.
- Woodcock will have a full plate, with as many as three coronavirus vaccines potentially needing review in coming months and two others that may convert to full agency approval after already gaining emergency authorization. Meanwhile, the FDA will need to work on a backlog of non-COVID drug approval decisions that have been put on hold because inspectors can’t travel to some manufacturing facilities.
Dive Insight:
It takes time for any new administration to fill appointments, so the FDA often goes without a permanent head as a new president takes office. For example, Stephen Ostroff, the deputy commissioner for foods and veterinary medicine, served as acting chief before Scott Gottlieb, former President Donald Trump’s first FDA commissioner, took over in May 2017.
Woodcock has directed the FDA’s Center for Drug Evaluation and Review since 2008, a job she also held from 1994 to 2005. She was detailed to Operation Warp Speed in May to assist in the development of coronavirus therapeutics, but Biden’s White House has put a new COVID-19 response team in place.
In a note to FDA employees, Woodcock wrote that while not legally obligated to recuse herself from FDA decisions regarding any COVID-19 treatments she worked with via Operation Warp Speed, she had done so and will continue to as acting administrator.
Gottlieb and another former commissioner, Robert Califf, praised the decision to anoint Woodcock acting chief. On Twitter, Gottlieb wrote that she has “uncommonly good judgment” and is respected on Capitol Hill for her “effectiveness and candor.”
“She will represent FDA’s prerogatives well in a time of crisis, and advance the interests of consumers and patients,” he wrote.
Califf, former President Barack Obama’s last FDA commissioner, wrote of Woodcock and her choice as chief of staff, Julie Tierney: “I have complete confidence in their dedication to public health and the well-being of the American people.”
Along with Woodcock, other potential Biden nominees include former commissioners Gottlieb, Mark McClellan and Magaret Hamburg, current principal deputy commissioner Amy Abernethy, and a former holder of Abernethy’s post, Joshua Sharfstein.
In addition to navigating the coronavirus vaccine, drug and testing response, the FDA this year is also going to see increased workload in its review of experimental genetic medicines; pressure to embrace innovative clinical trial designs; and development of new policies to be implemented with renewal of its prescription drug user fee program.
