Priorities for the Priority Review Voucher

Am J Trop Med Hyg. 2017 Jan 11;96(1):14-15. doi: 10.4269/ajtmh.16-0600. Epub 2016 Aug 29.

Abstract

The U.S. Congress created the priority review voucher program in 2007 to encourage development of drugs for neglected diseases. Under the voucher program, the developer of a drug for a neglected or rare pediatric disease that is approved by the U.S. Food and Drug Administration receives a bonus priority review voucher for another drug. As of 2016, four vouchers have sold for an average price of $200 million. Recent experience with the voucher program indicates strengths and weaknesses of the program, as well as a need for legislative changes.

MeSH terms

  • Anti-Infective Agents / standards
  • Drug Approval / methods*
  • Drug Approval / organization & administration*
  • Drug Discovery / economics
  • 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