1921
Volume 96, Issue 1
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract

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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2017-01-11
2017-11-22
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References

  1. Food and Drug Administration (FDA), 2008. Guidance for Industry: Tropical Disease Priority Review Vouchers. Available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM080599.pdf.
  2. Ridley DB, Grabowski HG, Moe JL, , 2006. Developing drugs for developing countries. Health Aff 25: 313324.[Crossref]
  3. Berman J, , 2015. Miltefosine, and FDA-approved drug for the ‘orphan disease’, leishmaniasis. Expert Opin Orphan Drugs 3: 727735.[Crossref]
  4. Varond AJ, , 2015. Priority Review Voucher Updates: Valuation, Eligibility, Reauthorization. Available at: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/08/priority-review-voucher-updates-valuation-eligibility-reauthorization.html.
  5. Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER), 2013. Review Designation Policy: MAPP 6020.3 Rev. 2. Available at: https://www.google.com/#q=ucm082000.
  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]
  8. Kesselheim AS, Maggs LR, Sarpatwari A, , 2015. Experience with the priority review voucher program for drug development. JAMA 314: 16871688.[Crossref]
  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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