Volume 96, Issue 1
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



The Neglected Tropical Disease Voucher Program is a Congressionally-mandated program intended to promote approval of products for tropical diseases because it provides spectacular financial compensation consequent to FDA approval of a priority product. Three drug approvals–artemether/lumifantrine for malaria, bedaquiline for multidrug resistant tuberculosis, miltefosine for leishmaniasis–have received Tropical Disease Vouchers to date. We give our view of the type of products that might qualify for a Tropical Disease Voucher, financial considerations in venturing capital to support product development, clinical ramifications of a successful product approval, and an overall evaluation of the Program.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


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  6. Food and Drug Administration (FDA), 2013. Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics. Available at: https://www.google.com/#q=fda+expedited+programs.
  7. Ridley DB, Régnier SA, , 2016. The commercial value for priority review vouchers. Health Aff 35: 776783.[Crossref]
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  9. Food and Drug Administration (FDA), 2009. Coartem Approval Letter. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022268s000TOC.cfm.
  10. Food and Drug Administration (FDA), 2012. Bedaquiline Approval Letter. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000TOC.cfm.
  11. Food and Drug Administration (FDA), 2014. Miltefosine Approval Letter. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204684Orig1s000TOC.cfm.
  12. Congress.gov, 2014. S.2917: Adding Ebola to the FDA Priority Review Voucher Program Act. Available at: https://www.congress.gov/bill/113th-congress/senate-bill/2917.

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  • Received : 08 Feb 2016
  • Accepted : 01 Aug 2016

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