Pandemic Perspectives: How COVID Emergency Use Authorizations Could Reshape US FDA
From re-examining the FDA’s place in the broader US government to how fast and flexible it can be clearing therapies in non-emergency times, the COVID-19 EUA experience is expected to have a long-lasting impact on the agency.
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The FDA Commissioner suggests the US may need to fix economic incentives that keep industry from completing studies of drugs granted speedier paths to market before opening those pathways to new disease areas, but expressed particular interest in thinking about how EUAs could be used for non-opioid pain treatments.
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.
Since the WHO’s pandemic declaration, the agency has granted 10 EUAs for therapeutics and three for vaccines, all of which were reviewed in less than 90 days; EUA requests from government entities boast two of the three fastest review times but were revoked or limited in the face of emerging evidence.