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

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. Emergency use authorizations (EUAs) provide much-needed therapies during pandemics, but when issued before sufficient evidence is available, may have unintended consequences. They can potentially promote ineffective therapies and hinder evidence generation. We need a transparent evidence-based process for EUA.

Automated summary

Emergency use authorizations (EUAs) provide much-needed therapies during pandemics, but when issued before sufficient evidence is available, may have unintended consequences. They can potentially promote ineffective therapies and hinder evidence generation. We need a transparent evidence-based process for EUA.