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

      research-article
      * ,
      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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          Author and article information

          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
          Affiliations
          [1]Harvard Law School, Program in Health Policy, Harvard University, Cambridge, MA, USA
          Author notes
          [* ] Corresponding author: E-mail: emily.a.largent@ 123456gmail.com
          Article
          lsw046
          10.1093/jlb/lsw046
          5570698
          28852537
          103619d2-3116-4750-b685-4475d8803dfd
          © 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

          History
          Page count
          Pages: 49
          Categories
          Original Article

          ebola,ethics,food and drug law,public health
          ebola, ethics, food and drug law, public health

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