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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

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 languageEnglish (US)
Pages (from-to)1686-1690
Number of pages5
JournalClinical Infectious Diseases
Volume74
Issue number9
DOIs
StatePublished - May 1 2022

Keywords

  • COVID-19
  • emergency use authorization
  • treatment

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Fingerprint

Dive into the research topics of 'Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords'. Together they form a unique fingerprint.

Cite this