Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords Academic Article uri icon

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abstract

  • 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.

authors

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

publication date

  • May 3, 2022