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Hahn Pledges FDA Independence While Maintaining Role On Warp Speed

 
• By Sarah Karlin-Smith

FDA Commissioner Stephen Hahn will participate in discussions or considerations of Operation Warp Speed, but won’t be involved in specific decisions or recommendations of the COVID-19 countermeasures public-private partnership to preserve agency independence, he said. The approach is less black and white than other agency officials, but may be acceptable given a commissioner’s more limited role in specific product reviews. Still, some worried about lines becoming blurred. 

FDA Commissioner Stephen Hahn
FDA Commissioner Stephen Hahn doesn't have a formal role on Warp Speed but will be involved in the COVID-19 project

US Food and Drug Administration Commissioner Stephen Hahn said he will not make any decisions for Operation Warp Speed, the country’s public-private effort to accelerate access for the US to a COVID-19 vaccine and therapetuics. The move is part of Hahn’s effort to maintain his and the agency’s regulatory independence during COVID-19, but the commissioner isn’t fully stepping back from Warp Speed, leading to mixed opinions about whether that independence will be fully realized.

“We have been very clear in writing and also verbally that we will maintain our regulatory independence. So Janet [Woodcock] will not participate in the regulatory decisions around therapy. And...

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