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Health Care Policy and Law
May 19, 2020

Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies

Author Affiliations
  • 1Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • 2Yale School of Medicine, New Haven, Connecticut
  • 3Yale Law School, New Haven, Connecticut
JAMA Intern Med. 2020;180(9):1145-1146. doi:10.1001/jamainternmed.2020.2402

On March 28, 2020, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the use of hydroxychloroquine and chloroquine for certain hospitalized patients diagnosed with coronavirus disease 2019 (COVID-19).1 Hydroxychloroquine and chloroquine have long been approved for the prophylaxis and treatment of malaria, with the former also used in the treatment of systemic lupus erythematosus and rheumatoid arthritis. Although these drugs appear to inhibit coronavirus replication in vitro, at the time of the EUA, there was no reliable clinical evidence to support the use of these drugs to treat COVID-19 in patients.

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