Top FDA Directors Recuse Themselves From COVID-19 Product Review Decisions

Two senior FDA officials have recused themselves from involvement in agency approval decisions for coronavirus therapeutics or vaccines due to their oversight roles in the administration’s new COVID-19 research initiative.

The recusal of Center for Drug Evaluation and Research (CDER) Director Janet Woodcock and Center for Biologics Evaluation and Research (CBER) Director Peter Marks was announced in an agency-wide email by Commissioner Stephen Hahn. It’s somewhat surprising since as federal employees, Woodcock and Marks are prohibited from holding financial interests in business regulated by the FDA.

Hahn said Woodcock and Marks will continue to lead their centers as they participate in Operation Warp Speed, the public-private partnership to accelerate the development, production and distribution of COVID-19 vaccines, therapeutics and diagnostics.

Under the program, Woodcock and Marks oversee its therapeutic and vaccine endeavors, respectively. Their recusals were likely motivated to allay concerns about alleged conflicts of interest that have surrounded the program.

President Trump generated controversy following his decision last Friday to appoint Moncef Slaoui, a venture capitalist and former head of GlaxoSmithKline’s vaccine program, as chief advisor of Operation Warp Speed.

The initiative, which has set a lofty goal of getting a working COVID-19 vaccine available by the end of 2020, drew criticism for having Slaoui in a top position. Advocacy group Public Citizen claimed the former pharma industry exec currently has “blatant financial conflicts of interests,” while Sen. Elizabeth Warren (D-Mass.) called his owning a large amount of Moderna stock “a huge conflict of interest.” Moderna is a frontrunner for the deployment of a vaccine.

Following the criticism, Slaoui resigned from Moderna’s board of directors and sold his holdings in the company, according to an HHS spokesperson, who said Slaoui has committed to donating the earnings from the shares to cancer research. — James Miessler