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Priority review vouchers do not expire.

The first PRV was granted by the FDA in 2009; 31 total PRVs were awarded through 2019, yet only 16 have been redeemed (Figure 1). Of note, the majority of these PRV grants and redemptions have been in the last 5 years. Number and types of priority review vouchers granted fiscal year (FY)20092019.

FDA's priority review voucher (PRV) programs are about drug development, and specifically the time and cost of drug development and the conditions a new drug is intended to treat.Once FDA begins its review, it takes more than a year on average for regulators to approve a drug.

Experts have estimated a PRV could be worth between $50 to $500 million--enough to help offset the investment required for discovery and development of a neglected disease drug or vaccine. Companies that don't have a top-selling drug or vaccine can sell or trade the voucher to another company.

FDA's priority review voucher (PRV) programs are about drug development, and specifically the time and cost of drug development and the conditions a new drug is intended to treat.Once FDA begins its review, it takes more than a year on average for regulators to approve a drug.

Uses of the priority review program As of 2017, fourteen priority review vouchers have been awarded, four for tropical diseases, and ten for rare pediatric diseases. The first priority review voucher was awarded in 2009 to Novartis for its approval of Coartem.

The voucher entitles the bearer to regulatory review in about six months rather than the standard ten months. The Food and Drug Administration (FDA) awards a voucher following approval of a treatment for a neglected disease, rare pediatric disease, or medical countermeasure.