title: The Tropical Disease Priority Review Voucher: A Game-Changer for Tropical Disease Products.
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.
authors: Fast Track Drugs and Biologics, North Potomac, Maryland.
authors: Jonathan
authors: J
authors: Berman
authors: Knight Therapeutics Inc., Westmount, Canada.
authors: Tanya
authors: T
authors: Radhakrishna
mesh_terms: D000890:Anti-Infective Agents / Q000592:standards; D017277:Drug Approval / Q000379:methods* / Q000458:organization & administration*; D055808:Drug Discovery; D006801:Humans; D058069:Neglected Diseases / Q000188:drug therapy*; D009965:Orphan Drug Production / Q000592:standards; D004364:Pharmaceutical Preparations; D014330:Tropical Medicine; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000890:Anti-Infective Agents; D004364:Pharmaceutical Preparations