FDA’s Priority Review Voucher System (PRVs)

 

FDA’s Priority Review Voucher System (PRVs)

USFDA’s priority review voucher program is an expedite review scheme that grants a voucher for priority review to a drug developer as an incentive to develop treatments for drugs that might otherwise not be profitable to develop because of a smaller pool of patients needing treatment.

FDAs PRV program designed to encourage development of new drug and biological products. Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease.

Quick Facts About Priority Review Vouchers

Priority review voucher program was first introduced by USFDA in 2007

There are three types of priority review voucher program 1. Treatments for Tropical diseases 2. Treatment for rare pediatric disease and 3.Medical countermeasure priority review vouchers.

The sponsor who receives a priority review voucher from FDA may transfer the voucher to another sponsor. (The statute does not limit the number of times a priority review   voucher may be transferred before the voucher is used).

Transfer of priority review voucher should be documented with a letter of transfer from the sponsor who has awarded the voucher and a letter from the new voucher owner acknowledging the transfer. A voucher cannot be redeemed unless a complete record of transfer is made available to the FDA.

The price of the Voucher depends  on supply and demand

Priority review vouchers do not expire (Voucher may be kept until needed or sold)

Voucher reduces review time of an application by USFDA from 10 months to 6 months.

At least 90 days before submission of the human drug application, for which the priority review voucher will be used, the sponsor planning to use the voucher must notify the FDA of intent to use the voucher and the date on which the sponsor intends to submit the application.

When using the voucher, a sponsor must pay an extra user fee (i.e., a separate priority review user fee) to support the review of the application based on the average cost of a priority new drug application/biologics license application (NDA/BLA) review in the previous fiscal year. Payment of this extra fee, to which the sponsor is legally committed as a result of the notification of its intent to use the voucher, is not subject to waivers, exemptions, reductions, or refunds.

Priority review voucher have an identification number, which should be referred to when redeeming the voucher.

Following diseases are considered tropical diseases for priority review voucher purposes.

ØTuberculosis	Ø Malaria	Ø Blinding trachoma
Ø Buruli Ulcer	Ø Cholera	Ø Dengue/Dengue haemorrhagic fever
Ø Dracunculiasis (guinea-worm disease)	Ø Fascioliasis	Ø Human African trypanosomiasis
Ø Leishmaniasis	Ø Leprosy	Ø Lymphatic filariasis
Ø Onchocerciasis	Ø Schistosomiasis	Ø Soil transmitted helminthiasis
Ø Yaws	Ø Filovirus Diseases	Ø Zika Virus Disease
Ø Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by order of the Secretary.