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

Jonathan Berman, Tanya Radhakrishna
Author Information
  1. Jonathan Berman: Fast Track Drugs and Biologics, North Potomac, Maryland.
  2. Tanya Radhakrishna: Knight Therapeutics Inc., Westmount, Canada.

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.

References

  1. Health Aff (Millwood). 2006 Mar-Apr;25(2):313-24 [PMID: 16522573]
  2. JAMA. 2015 Oct 27;314(16):1687-8 [PMID: 26414802]
  3. Health Aff (Millwood). 2016 May 1;35(5):776-83 [PMID: 27140982]

MeSH Term

Anti-Infective Agents
Drug Approval
Drug Discovery
Humans
Neglected Diseases
Orphan Drug Production
Pharmaceutical Preparations
Tropical Medicine
United States
United States Food and Drug Administration

Chemicals

Anti-Infective Agents
Pharmaceutical Preparations

Word Cloud

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