COVID-19 Staff Shakeup: Woodcock Moves to Commissioner's Office As Marks Drops Out Of 'Warp'
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.
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It remains uncertain whether Acting Commissioner Woodcock will be nominated for the post. Regardless, the drug center she has run for most of three decades is going to have to adjust to new management.
To help with the transition to Biden’s COVID-19 response, Woodcock will retain some therapeutic development duties in the program the Trump administration had called Operation Warp Speed.
Agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give Biden team cushion to confirm a permanent leader of whom a top contender is former senior FDA staffer Joshua Sharfstein, a proponent of drug reforms that may irk manufacturers.