Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords

Adarsh Bhimraj; Rebecca L. Morgan; Amy Hirsch Shumaker; Valery Lavergne; Lindsey Baden; Vincent Chi Chung Cheng; Kathryn M. Edwards; Rajesh T. Gandhi; Jason C. Gallagher; William J. Muller; John C. O'Horo; Shmuel Shoham; Dana Swartzberg Wollins; Yngve Falck-Ytter

doi:10.1093/cid/ciab880

Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords

Adarsh Bhimraj, Rebecca L. Morgan, Amy Hirsch Shumaker, Valery Lavergne, Lindsey Baden, Vincent Chi Chung Cheng, Kathryn M. Edwards, Rajesh T. Gandhi, Jason C. Gallagher, William J. Muller, John C. O'Horo, Shmuel Shoham, Dana Swartzberg Wollins, Yngve Falck-Ytter

School of Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

Given the urgent need for treatments during the coronavirus disease 2019 pandemic, the US Food and Drug Administration issued emergency use authorizations (EUAs) for multiple therapies. In several instances, however, these EUAs were issued before sufficient evidence of a given therapy's efficacy and safety were available, potentially promoting ineffective or even harmful therapies and undermining the generation of definitive evidence. We describe the strengths and weaknesses of the different therapeutic EUAs issued during this pandemic. We also contrast them to the vaccine EUAs and suggest a framework and criteria for an evidence-based, trustworthy, and publicly transparent therapeutic EUA process for future pandemics.

Original language	English (US)
Pages (from-to)	1686-1690
Number of pages	5
Journal	Clinical Infectious Diseases
Volume	74
Issue number	9
DOIs	https://doi.org/10.1093/cid/ciab880
State	Published - May 1 2022

Keywords

COVID-19
emergency use authorization
treatment

ASJC Scopus subject areas

Microbiology (medical)
Infectious Diseases

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10.1093/cid/ciab880

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Bhimraj, A., Morgan, R. L., Shumaker, A. H., Lavergne, V., Baden, L., Cheng, V. C. C., Edwards, K. M., Gandhi, R. T., Gallagher, J. C., Muller, W. J., O'Horo, J. C., Shoham, S., Wollins, D. S., & Falck-Ytter, Y. (2022). Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords. Clinical Infectious Diseases, 74(9), 1686-1690. https://doi.org/10.1093/cid/ciab880

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T2 - Double-edged Swords

AU - Bhimraj, Adarsh

AU - Morgan, Rebecca L.

AU - Shumaker, Amy Hirsch

AU - Lavergne, Valery

AU - Baden, Lindsey

AU - Cheng, Vincent Chi Chung

AU - Edwards, Kathryn M.

AU - Gandhi, Rajesh T.

AU - Gallagher, Jason C.

AU - Muller, William J.

AU - O'Horo, John C.

AU - Shoham, Shmuel

AU - Wollins, Dana Swartzberg

AU - Falck-Ytter, Yngve

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AB - Given the urgent need for treatments during the coronavirus disease 2019 pandemic, the US Food and Drug Administration issued emergency use authorizations (EUAs) for multiple therapies. In several instances, however, these EUAs were issued before sufficient evidence of a given therapy's efficacy and safety were available, potentially promoting ineffective or even harmful therapies and undermining the generation of definitive evidence. We describe the strengths and weaknesses of the different therapeutic EUAs issued during this pandemic. We also contrast them to the vaccine EUAs and suggest a framework and criteria for an evidence-based, trustworthy, and publicly transparent therapeutic EUA process for future pandemics.

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KW - emergency use authorization

KW - treatment

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Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords

Abstract

Keywords

ASJC Scopus subject areas

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