Woodcock, Marks Recusals From COVID-19 Product Reviews 'Protect FDA's Reputation'
FDA experts say there is deep bench in CDER and CBER to tackle review questions while directors Janet Woodcock and Peter Marks help lead Operation Warp Speed; regulatory community is 'reassured' they will oversee advancement of COVID-19 therapeutics and vaccines.
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CBER Director Marks will no longer have to recuse himself from COVID-19 product reviews, a move seen as resoundingly positive by former senior FDA leaders. CDER Director Woodcock will now be free to focus solely on COVID-19 and bring her unique depth of agency experience to the Trump Administration's effort to speed development of vaccines, therapeutics and diagnostics for coronavirus.
FDA’s Peter Marks and Janet Woodcock will be on the bridge for Operation Warp Speed; Moncef Slaoui says early clinical data on one vaccine candidate makes him confident that a few hundred million doses of a vaccine can be available by the end of the year.
The US FDA commissioner does not generally get involved with day-to-day activities, former FDA chiefs say, but perception of bias could be lasting problem.