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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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JAMA Network. COVID-19 and the FDA, with Commissioner Stephen Hahn, MD. Accessed August 3, 2020. https://www.youtube.com/watch?v=UdmaU2-C_wE&feature=youtu.be
2.
Shah  A , Marks  PW , Hahn  SM .  Unwavering regulatory safeguards for COVID-19 vaccines.   JAMA. Published online August 7, 2020. doi:10.1001/jama.2020.15725PubMedGoogle Scholar
3.
Federal Food, Drug, and Cosmetic Act, 21 USC §360bbb-3(g) (1938).
4.
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
5.
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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Letter to Dr Rick Bright re: request for Emergency Use Authorization for use of chloroquine phosphate or hydroxychloroquine sulfate supplied from the strategic national stockpile for treatment of 2019 coronavirus disease. Published March 28, 2020. Accessed August 3, 2020. https://www.fda.gov/media/136534/download
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Carpenter  D .  Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton University Press; 2010.
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Hahn  SM . FDA commissioner: no matter what, only a safe, effective vaccine will get our approval. Washington Post. Published August 5, 2020. Accessed August 9, 2020. https://www.washingtonpost.com/opinions/fda-commissioner-no-matter-what-only-a-safe-effective-vaccine-will-get-our-approval/2020/08/05/e897d920-d74e-11ea-aff6-220dd3a14741_story.html
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Lurie  N , Sharfstein  JM , Goodman  JL .  The development of COVID-19 vaccines.   JAMA. 2020;324(5):439-440. doi:10.1001/jama.2020.12461PubMedGoogle ScholarCrossref
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Development and licensure of vaccines to prevent COVID-19: guidance for industry. Published June 2020. Accessed August 3, 2020. https://www.fda.gov/media/139638/download
AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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