Examples
Worked examples
- Is an instance
United Therapeutics earned a rare pediatric disease PRV when FDA approved dinutuximab (Unituxin) for neuroblastoma, then sold that voucher to AbbVie in 2015 for $350 million — the highest publicly reported PRV sale price.
- Is an instance
A sponsor that wins approval of a treatment for a listed tropical disease such as malaria or Chagas disease, with no active ingredient previously approved in any other application, can be awarded a tropical disease PRV and later apply it to speed FDA review of an unrelated product in its own pipeline.
Counter-examples
Looks similar, but isn't
- Not an instance
Ordinary priority review designation granted because a specific application itself represents a significant improvement over available therapy is not a PRV — that designation only speeds review of that same application and cannot be sold or transferred to another product or company.
- Not an instance
Orphan drug designation, breakthrough therapy designation, and accelerated approval are separate FDA mechanisms addressing development incentives or approval pathways; none of them create a transferable review-timeline asset the way a PRV does.
Editorial commentary
A priority review voucher (PRV) is an incentive FDA awards to the sponsor of certain approved drug applications, entitling the holder to redeem it for priority review of a different, future drug application at the FDA of their choosing. Priority review shortens FDA’s target review clock from the standard 10 months to 6 months.
Which approvals qualify
Congress created several PRV programs targeting specific public-health priorities where ordinary market incentives are weak: rare pediatric disease PRVs (for approved treatments of certain rare diseases primarily affecting children), tropical disease PRVs (for treatments of specified neglected tropical diseases), and a medical countermeasure PRV program (for products addressing certain public-health threats). Each program has its own qualifying-disease list and statutory sunset/renewal history, so eligibility depends on which specific program a given approval falls under.
Why vouchers are valuable and transferable
A PRV is transferable: the sponsor that earns one through a qualifying approval can sell it to a different company, which can then apply it to accelerate review of one of its own future applications. Because shaving months off an FDA review clock can be worth a great deal for a high-value drug, vouchers have historically traded for large sums between companies, creating a market-based incentive for sponsors to pursue drug development in these underserved disease areas even when the underlying commercial market is otherwise small.
References
- FDA, Rare Pediatric Disease Priority Review Voucher Program
- FDA, Tropical Disease Priority Review Voucher Program
Frequently Asked Questions
What is the difference between priority review and a priority review voucher?
Priority review is the shortened FDA target review clock itself, six months instead of the standard ten. A priority review voucher (PRV) is a separate, awarded credential that entitles its holder to redeem priority review for a different, future drug application of their choosing, rather than for the approval that earned it.
How do you qualify for a priority review voucher?
A sponsor earns a PRV by winning FDA approval of a product under one of the specific programs Congress created for it: rare pediatric disease, tropical disease, or medical countermeasures. Each program has its own qualifying-disease list and statutory sunset/renewal history, so eligibility depends on which program a given approval falls under.
What is a tropical disease priority review voucher?
It is one of the PRV programs Congress created, awarded for FDA approval of treatments for specified neglected tropical diseases. Like the other PRV programs, it exists to encourage drug development in disease areas where ordinary market incentives are weak.
Can a priority review voucher be sold or transferred?
Yes. A PRV is transferable: the sponsor that earns one can sell it to a different company, which can then apply it to accelerate FDA review of one of its own future applications.
How much is a priority review voucher worth?
Vouchers have historically traded for large sums between companies, because shaving months off an FDA review clock can be worth a great deal for a high-value drug. The exact value of any given voucher depends on the deal struck between buyer and seller.
Machine-readable encodings
Use in your systems
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