The Tropical Disease Priority Review Voucher: A Game-Changer for Tropical Disease Products

Am J Trop Med Hyg. 2017 Jan 11;96(1):11-13. doi: 10.4269/ajtmh.16-0099. Epub 2016 Aug 29.

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.

MeSH terms

  • Anti-Infective Agents / standards
  • Drug Approval / methods*
  • Drug Approval / organization & administration*
  • Drug Discovery
  • Humans
  • Neglected Diseases / drug therapy*
  • Orphan Drug Production / standards
  • Pharmaceutical Preparations
  • Tropical Medicine*
  • United States
  • United States Food and Drug Administration*

Substances

  • Anti-Infective Agents
  • Pharmaceutical Preparations