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Woodcock, Marks to recuse themselves from FDA reviews of COVID-19 products

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FDA center directors Janet Woodcock and Peter Marks will not participate in reviews of COVID-19 products after taking on leadership roles in Operation Warp Speed, FDA Commissioner Stephen Hahn announced in an email to agency staff. Woodcock directs FDA’s Center for Drug Evaluation and Research (CDER) and Marks directs the Center for Biologics Evaluation and Research (CBER).

The email, sent Sunday morning, notes that on Friday “it was announced that our own Drs. Janet Woodcock and Peter Marks will be bringing their diverse experience to cross-government efforts to expedite the development and availability of therapeutics and vaccines to combat COVID-19 under the Operation Warp Speed Project.”

Hahn wrote, “Woodcock and Marks will continue as directors of their respective centers while working closely with other center and agency leadership to ensure continuity of day-to-day operations. They will also recuse themselves from the supervisory chain of command in matters related to product review decisions for applications related to the areas that they are advancing that have a nexus to COVID-19.”

Vaccine development veteran Moncef Slaoui was named chief adviser and General Gustave Perna was appointed COO of Operation Warp Speed.

Marks will oversee vaccine development and Woodcock heads therapeutics for the initiative.

Bruce Tromberg, director of NIH’s National Institute of Biomedical Imaging and Bioengineering, is responsible for diagnostics.

The administration describes the initiative as a “public-private partnership to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of HHS, including CDC, FDA, NIH, and the Biomedical Advanced Research and Development Authority (BARDA); the Department of Defense; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs.”

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