Priorities for the Priority Review Voucher.

David B Ridley
Author Information
  1. David B Ridley: Duke University, Durham, North Carolina.

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.

References

  1. Clin Pharmacol Ther. 2009 Jun;85(6):573-5 [PMID: 19451908]
  2. JAMA. 2015 Oct 27;314(16):1687-8 [PMID: 26414802]
  3. Health Aff (Millwood). 2016 May 1;35(5):776-83 [PMID: 27140982]
  4. Am J Trop Med Hyg. 2017 Jan 11;96(1):11-13 [PMID: 27573627]
  5. Health Aff (Millwood). 2006 Mar-Apr;25(2):313-24 [PMID: 16522573]
  6. Health Aff (Millwood). 2006 Mar-Apr;25(2):420-8 [PMID: 16522582]
  7. Health Econ. 2007 May;16(5):491-511 [PMID: 17013993]

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

Created with Highcharts 10.0.0voucherprogramUSpriorityreviewneglecteddrugCongresscreated2007encouragedevelopmentdrugsdiseasesdeveloperrarepediatricdiseaseapprovedFoodDrugAdministrationreceivesbonusanother2016fourvoucherssoldaverageprice$200millionRecentexperienceindicatesstrengthsweaknesseswellneedlegislativechangesPrioritiesPriorityReviewVoucher

Similar Articles

Cited By