FDA’s Priority Review Voucher System (PRVs)
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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
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Priority review voucher program was first introduced by USFDA
in 2007
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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.
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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).
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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.
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The price of the Voucher depends on supply and
demand
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Priority review vouchers do not expire (Voucher may be kept
until needed or sold)
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Voucher reduces review time of an application by USFDA from 10
months to 6 months.
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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.
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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.
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Priority review voucher have an identification number, which
should be referred to when redeeming the voucher.
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Following diseases are considered tropical diseases for priority
review voucher purposes.
ØTuberculosis
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Ø Malaria
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Ø Blinding
trachoma
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Ø Buruli
Ulcer
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Ø Cholera
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Ø Dengue/Dengue
haemorrhagic fever
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Ø Dracunculiasis
(guinea-worm disease)
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Ø Fascioliasis
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Ø Human
African trypanosomiasis
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Ø Leishmaniasis
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Ø Leprosy
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Ø Lymphatic
filariasis
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Ø Onchocerciasis
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Ø Schistosomiasis
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Ø Soil
transmitted helminthiasis
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Ø Yaws
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Ø Filovirus
Diseases
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Ø Zika
Virus Disease
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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.
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