Volume 96, Issue 1
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



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.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Article metrics loading...

The graphs shown below represent data from March 2017
Loading full text...

Full text loading...



  1. Ridley DB, Grabowski HG, Moe JL, 2006. Developing drugs for developing countries. Health Aff 25: 313324.[Crossref]
    [Google Scholar]
  2. Ridley DB, Régnier SA, 2016. The commercial market for priority review vouchers. Health Aff 35: 776783.[Crossref]
    [Google Scholar]
  3. Hensley S, 2015. Price Rises for Ticket to a Quicker Drug Review by FDA: National Public Radio. Available at: http://www.npr.org/sections/health-shots/2015/08/19/432887081/price-rises-for-ticket-to-a-quicker-drug-review-by-fda. Accessed August 21, 2015.
    [Google Scholar]
  4. Berman J, Radhakrishna T, 2017. The tropical disease priority review voucher: a game-changer for tropical disease products. Am J Trop Med Hyg 96: 1113.
    [Google Scholar]
  5. Adams CP, Brantner VV, 2006. Estimating the cost of new drug development: is it really $802 million? Health Aff 25: 420428.[Crossref]
    [Google Scholar]
  6. Ridley DB, 2015. The Regulatory Burden of the Priority Review Voucher Program. Health Affairs Blog. Available at: http://healthaffairs.org/blog/2015/10/28/the-regulatory-burden-of-the-priority-review-voucher-program/. Accessed July 7, 2016.
    [Google Scholar]
  7. Kesselheim AS, 2009. Priority review vouchers: an inefficient and dangerous way to promote neglected-disease drug development. Clin Pharmacol Ther 85: 573575.[Crossref]
    [Google Scholar]
  8. Kesselheim AS, Maggs LR, Sarpatwari A, 2015. Experience with the priority review voucher program for drug development. JAMA 314: 16871688.[Crossref]
    [Google Scholar]
  9. Berndt ER, Glennerster R, Kremer MR, Lee J, Levine R, Weizsäcker G, Williams H, 2007. Advance market commitments for vaccines against neglected diseases: estimating costs and effectiveness. Health Econ 16: 491511.[Crossref]
    [Google Scholar]
  • Received : 21 Jul 2016
  • Accepted : 01 Aug 2016
  • Published online : 11 Jan 2017
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error