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EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future

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Journal of Law and the Biosciences

Oxford University Press

Ebola, ethics, food and drug law, public health

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      Abstract

      In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EVD. As a result, the outbreak spurred interest in developing novel treatments, sparked calls to use experimental interventions in the field, and highlighted challenges to the standard approach to FDA approval of new drugs. Although the outbreak was geographically centered in West Africa, it showcased FDA's global role in drug development, approval, and access. FDA's response to EVD highlights the panoply of agency powers and demonstrates the flexibility of FDA's regulatory framework. This paper evaluates the strengths and weaknesses of FDA's response and makes policy recommendations regarding how FDA should respond to new and re-emerging public health threats. In particular, it argues that greater emphasis should be placed on drug development in interoutbreak periods and on assuring access to approved products. The current pandemic of Zika virus infection is but one example of an emerging health threat that will require FDA involvement in order to achieve a successful response.

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      Affiliations
      Harvard Law School, Program in Health Policy, Harvard University, Cambridge, MA, USA
      Author notes
      [* ] Corresponding author: E-mail: emily.a.largent@ 123456gmail.com
      Journal
      J Law Biosci
      J Law Biosci
      jlb
      jlb
      Journal of Law and the Biosciences
      Oxford University Press
      2053-9711
      December 2016
      16 September 2016
      16 September 2016
      : 3
      : 3
      : 489-537
      5570698 10.1093/jlb/lsw046 lsw046
      © The Author 2016. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School.

      This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@ 123456oup.com

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      Pages: 49
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      Original Article

      public health, food and drug law, ethics, ebola

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