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Pandemic Perspectives: How COVID May Reshape US Emergency Use Authorizations

 
• By Sarah Karlin-Smith

FDA policy experts Jesse Goodman, Mark McClellan, Peter Lurie, David Bowen, Patti Zettler, and Aaron Kesselheim suggest ideas and points to consider in using the COVID-19 experience to assess whether standards for EUAs should be adjusted.

COVID-19 has been the most comprehensive test case for the US Food and Drug Administration’s emergency use authorization pathway since Congress enacted the 2004 Project Bioshield Act giving the agency the ability to permit use of unapproved products against a threat to public health and safety.

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