Emergency Use Authorizations During the COVID-19 Pandemic—Lessons From Hydroxychloroquine for Upcoming Vaccine Approval | Infectious Diseases | JN Learning | AMA Ed Hub [Skip to Content]
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Emergency Use Authorizations During the COVID-19 PandemicLessons From Hydroxychloroquine for Vaccine Authorization and Approval

Educational Objective
To understand how Emergency Use Authorizations have been used during the COVID-19 Pandemic
1 Credit CME

In response to the novel coronavirus disease 2019 (COVID-19) crisis, the Food and Drug Administration (FDA), via its Emergency Use Authorization (EUA) authority, initially provided, and then revoked, authorization for use of hydroxychloroquine for treating patients with COVID-19. This process was politically and scientifically contentious and illustrates central problems that can arise with emergency drug authorizations during crises. These problems include the authorization of potentially ineffective or unsafe therapeutics, the appearance of nonexpert political advocacy generating public pressure for product authorizations with questionable safety and efficacy, and the imposition of significant costs on the health of the public and on the credibility and influence of regulatory agencies such as the FDA.

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Article Information

Corresponding Author: Kyle Thomson, JD, MPH, American Medical Association, 25 Massachusetts Ave NW, Ste 600, Washington, DC 20001 (kyle.thomson@ama-assn.org).

Published Online: August 31, 2020. doi:10.1001/jama.2020.16253

Conflict of Interest Disclosures: Mr Thomson reported being associate chief counsel in the Office of the Chief Counsel of the FDA from 2012 to 2020. No other disclosures were reported.

Disclaimer: The views, thoughts, and opinions expressed in this article are solely those of the authors and do not necessarily reflect the authors’ employers.

References
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Emergency Use Authorization of medical products and related authorities: guidance for industry and other stakeholders. Published January 2017. Accessed August 3, 2020. https://www.fda.gov/media/97321/download
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Gautret  P , Lagier  J-C , Parola  P ,  et al.  Hydroxychloroquine and azithromycin as a treatment of COVID-19.   Int J Antimicrob Agents. 2020;56(1):105949. doi:10.1016/j.ijantimicag.2020.105949PubMedGoogle Scholar
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