Priorities for the Priority Review Voucher

David B Ridley

doi:10.4269/ajtmh.16-0600

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.

Highlights

The U.S Congress created the priority review voucher program in 2007 to encourage development of drugs for neglected diseases
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

Summary

Introduction

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. The U.S Congress created the priority review voucher program in 2007 to encourage development of drugs for neglected diseases. The developer of a drug for a neglected or rare pediatric disease that is approved by the U.S Food and Drug Administration (FDA) receives a bonus priority review voucher for another drug.

Results

Conclusion