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Comment & Response
April 19, 2016

Efficacy of the Priority Review Voucher Program

Author Affiliations
  • 1Duke University, Durham, North Carolina
  • 2BIO Ventures for Global Health, Seattle, Washington
  • 3Lion’s Head Global Partners, London, United Kingdom

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(15):1659-1660. doi:10.1001/jama.2016.0377

To the Editor Dr Kesselheim and colleagues1 assessed the priority review voucher program, which rewards companies for US Food and Drug Administration (FDA) registration of treatments for rare pediatric or neglected diseases. We have a more optimistic view of the program.

First, the authors wrote that “several more promising approaches exist,” including public funding of “basic science research.” Although funding from the National Institutes of Health (NIH) is important for basic science, the NIH rarely funds late-stage product development. Additional incentives, like the priority review voucher, are needed to advance drugs through approval. The voucher program does not preclude other mechanisms because public funds are not used.2 The FDA charges a user fee (currently $2.7 million) to offset the cost of the program.