Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic

Drug Discov Today. 2021 Feb;26(2):593-603. doi: 10.1016/j.drudis.2020.11.025. Epub 2020 Nov 27.


The US Food and Drug Administration (FDA) Expanded Access (EA) Program, which allows for compassionate uses of unapproved therapeutics and diagnostics outside of clinical trials, has gained significant traction during the Coronavirus 2019 (COVID-19) pandemic. While development of vaccines has been the major focus, uncertainties around new vaccine safety and effectiveness have spawned interest in other pharmacological options. Experimental drugs can also be approved under the FDA Emergency Use Authorization (EUA) program, designed to combat infectious disease and other threats. Here, we review the US experience in 2020 with pharmacological EA and EUA approvals during the pandemic. We also provide a description of, and clinical rationale for, each of the EA- or EUA-approved drugs (e.g. remdesivir, convalescent plasma, propofol 2%, hydroxychloroquine, ruxolitinib, bamlanivimab, baricitinib, casirivimab plus imdevimab) during the pandemic and concluding reflections on the EA program and its potential future uses.

Publication types

  • Review

MeSH terms

  • Antiviral Agents* / classification
  • Antiviral Agents* / pharmacology
  • COVID-19 Drug Treatment*
  • COVID-19 Vaccines / pharmacology*
  • COVID-19* / epidemiology
  • COVID-19* / prevention & control
  • Compassionate Use Trials* / methods
  • Compassionate Use Trials* / trends
  • Drug Approval
  • Humans
  • SARS-CoV-2
  • United States


  • Antiviral Agents
  • COVID-19 Vaccines