Assessing COVID-19 Emergency Use Authorizations

Efthimios Parasidis, Micah L. Berman & Patricia J. Zettler

Abstract

Emergency Use Authorizations (EUAs) have been integral to the federal government’s response to the COVID-19 pandemic. During a public health emergency, the Federal Food, Drug, and Cosmetic Act permits the U.S. Food and Drug Administration (FDA) the authority to issue EUAs to allow the distribution of unapproved medical products, or of already-authorized products for unapproved uses, when certain criteria are met, including that there are no adequate, approved, and available alternatives. When compared to standards for FDA approval of drugs, medical devices, and vaccines, the EUA pathway has a lower statutory bar to market. This lower bar provides FDA with flexibility in responding to public health emergencies, but also permits marketing of medical products where safety and effectiveness data are less robust than with full approval. Within the first thirteen months of the pandemic, FDA issued over 400 EUAs for a wide range of medical products. Products authorized under EUAs have had varying degrees of efficacy, safety, and reliability. While some EUA medical products have been essential elements of the health and public health responses to the pandemic, others were pulled from the market because they ultimately proved to be unsafe or ineffective. This Article discusses the EUA framework and the motivations that led to its creation, examines FDA’s use of the EUA process during the COVID-19 pandemic, and offers suggestions for ways that Congress and FDA can recalibrate the EUA mechanism to help it better achieve its goals.

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