US Food and Drug Administration (FDA) Emergency Use Authorization: Glass Half Full or Glass Half Empty?

Recently, the US Food and Drug Administration (FDA) issued emergency use authorization (EUA) for convalescent plasma (CP) for the treatment of hospitalized patients with coronavirus disease 2019 based on a non-peer-reviewed, open-label, observational study. Issuance of an EUA without a proven random...

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Bibliographic Details
Published in:Clinical infectious diseases 2021-08, Vol.73 (3), p.549-552
Main Authors: Guharoy, Roy, Krenzelok, Edward P
Format: Article
Language:English
Subjects:
COVID-19 - drug therapy
COVID-19 - therapy
Humans
Hydroxychloroquine
Immunization, Passive
SARS-CoV-2
United States
United States Food and Drug Administration
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Summary:Recently, the US Food and Drug Administration (FDA) issued emergency use authorization (EUA) for convalescent plasma (CP) for the treatment of hospitalized patients with coronavirus disease 2019 based on a non-peer-reviewed, open-label, observational study. Issuance of an EUA without a proven randomized, controlled trial (RCT) sets a dangerous precedent since the premature action drives healthcare providers and patients away from RCTs that are essential for determining the efficacy and safety of CP. More caution should have been taken based on what was learned from the recent debacle related to the rescinded EUA of hydroxychloroquine and chloroquine, which were approved initially based on an anecdotal report. The FDA process for determining efficacy and safety must be based solely on data from RCTs in order to sustain public and professional trust for future treatment and vaccine efforts to be successful.
ISSN:1058-4838
1537-6591
DOI:10.1093/cid/ciaa1653