Pandemic Perspectives: COVID’s Unprecedented Experience With Emergency Use Authorizations

The US Food and Drug Administration's EUA pathway has seen more use in the therapeutic and vaccine space during the current pandemic than it has in its entire 16-year history and in many cases the potential eligible populations for the authorized products are far larger than past EUAs. Pink Sheet infographic compares details of past and present EUAs.

COVID Causes Exponential Increase in Emergency Use Authorizations
Many EUAs linger after the height of the emergency that sparked their authorizations. • Source: Infogram

The COVID-19 pandemic has made a once obscure US Food and Drug Administration regulatory authority – the Emergency Use Authorization –a household name. The unusual level of use and political attention has led to calls to re-evaluate the pathway once the US gets through the current crisis, including discussion of whether the standard, which is lower than that of a traditional marketing approval, should be elevated, and whether EUAs should eventually transition to a full approval or be pulled. (Also see "Pandemic Perspectives: How COVID May Reshape US Emergency Use Authorizations" - Pink Sheet, 30 March, 2021.) To better inform the debate, Pink Sheet looked at the trajectory and types of EUAs issued since Congress enacted the pathway in 2004, which permits use of unapproved products against a threat to public health and safety.

More from Review Pathways

More from Pathways & Standards