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Pandemic Perspectives: How COVID Emergency Use Authorizations Could Reshape US FDA

 
• By Sarah Karlin-Smith

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. 

Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
COVID-19 emergency use authorization experiences could transform FDA • Source: Shutterstock
Pandemic Perspectives

One year on from the World Health Organization declaring COVID-19 a global pandemic on 11 March 2020, editors across Informa Pharma Intelligence publications are taking a closer look at its impact and possible lasting implications for the biopharma and medtech industries.

The COVID-19 pandemic has drawn an unusual level of public attention to the daily work processes and operations of the US Food and Drug Administration. But much of the work being spotlighted wasn’t “business as usual.” The agency has worked overtime and used flexibilities afforded it due to the nature of the global public emergency to get experimental products to Americans at record speed – most notably through the emergency use authorization pathway.

A little over a year into the health emergency with the promise of multiple authorized vaccines making it possible for...

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