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PRIORITY REVIEW VOUCHER WATCH
History
2006
A “priority review voucher” program for neglected diseases was first proposed in a research article by economists David B. Ridley, Henry G. Grabowski, and Jeffrey L. Moe.
2007
The Food and Drug Administration Amendments Act (FDAAA) of 2007 enacted the tropical disease priority review voucher program.
Eligibility: Tropical disease priority review voucher program
The term "tropical disease" means any of the following:
The term "tropical disease product application" means a human drug application for prevention or treatment of a tropical disease, that is eligible for priority review and has no active ingredient of which has been approved in any other application.
The priority review voucher will be awarded to the sponsor of a tropical disease product application upon approval of such tropical disease product application.
The sponsor of a priority review voucher may transfer (including by sale) the entitlement to such voucher. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.
2008
2009
The first tropical disease priority review voucher was awarded to Novartis in April 2009 for Coartem tablets (artemether and lumefantrine) which was approved for uncomplicated malaria infections due to Plasmodium falciparum in patients of 5 kg bodyweight and above.
2010
2011
The first tropical disease priority review voucher redemption was by Novartis for Ilaris (canakinumab) the treatment of gouty arthritis attacks in patients who cannot obtain adequate response with NSAIDS or colchicine. This application received a complete response letter from the FDA.
2012
The Food and Drug Administration Safety and Innovation Act of 2012 enacted the rare pediatric disease priority review voucher program.
Eligibility: Rare pediatric disease priority review voucher program
The term "rare pediatric disease" means a disease that is:
The term "rare pediatric disease product application" means a human drug application, for prevention or treatment of a rare pediatric disease, that is eligible for priority review and has no active ingredient of which has been approved in any other application. The application must not seek approval for an adult indication.
The priority review voucher will be awarded to the sponsor of a rare pediatric disease product application upon approval of such rare pediatric disease product application.
The sponsor of a priority review voucher may transfer (including by sale) the entitlement to such voucher. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.
Termination of the rare pediatric disease priority review voucher program
2013
2014
2015
2016
Eligibility: Material threat medical countermeasure priority review voucher program
The term "material threat medical countermeasure application" means a human drug application that is eligible for priority review and has no active ingredient of which has been approved in any other application and is for a drug intended for use:
The priority review voucher will be awarded to the sponsor of a material threat medical countermeasure product application upon approval of such material threat medical countermeasure application. Priority review vouchers may not be awarded after October 1, 2023.
The sponsor of a priority review voucher may transfer (including by sale) the entitlement to such voucher. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.
2017
2018
2019
2020
2021
2022
2023
The material threat medical countermeasure priority review voucher program ended on October 1, 2023.
2024
2025
On February 12th, the Give Kids a Chance Act was reintroduced, seeking to extend the FDA rare pediatric disease priority review voucher program to September 2029.
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