Priority Review Voucher (PRV)

A priority review voucher (PRV) is an FDA incentive awarded to the sponsor of an approved drug or biologic that meets the criteria of one of two statutory programs: the rare pediatric disease PRV program or the tropical disease PRV program. The voucher entitles its holder to redeem it for priority review of a different marketing application at a later date — it is not tied to further use of the product that earned it, and it can be sold to another company entirely. That transferability is what makes a PRV functionally different from ordinary priority review designation: it converts a regulatory timeline benefit into a tradable asset.

What counts as a PRV

A PRV is created only when FDA approves a qualifying application under one of two authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act):

• Rare Pediatric Disease PRV program (FD&C Act section 529) — awarded when FDA approves a drug or biologic for a “rare pediatric disease,” a serious or life-threatening condition affecting primarily people age 18 or younger and affecting fewer than 200,000 people in the United States.
• Tropical Disease PRV program (FD&C Act section 524) — awarded when FDA approves a drug or biologic for the prevention or treatment of a specified “tropical disease” (a statutory list including malaria, tuberculosis, Zika, Chagas disease, and several others added over time), where the application contains no active ingredient previously approved in any other application.

Both programs require that the approved application otherwise qualify for priority review consideration on its own merits before FDA will issue the voucher.

What the voucher actually grants

FDA operates two review-timeline goals under the Prescription Drug User Fee Act (PDUFA): a standard review goal of ten months from filing, and a priority review goal of six months from filing, reserved for applications for products that would provide a significant improvement over available therapy. A PRV lets its holder request priority review — the six-month goal — for a subsequent, unrelated marketing application that would not otherwise qualify for it. The voucher does not guarantee approval; it only shortens FDA’s target review clock for that later submission. FDA still charges an additional user fee to redeem a voucher, separate from the standard PDUFA application fee.

Transferability and market value

Unlike priority review designation earned on a product’s own merits, a PRV is explicitly assignable: the sponsor that earns it can use it on a future application of its own, or sell or transfer it to a different company. This created a secondary market in vouchers, since a company with no near-term application to accelerate can still monetize the incentive by selling it to a company that does. Reported sale prices have varied widely with supply and buyer urgency — the highest publicly reported price was $350 million, paid by AbbVie in 2015 for a rare pediatric disease voucher that United Therapeutics earned on its approval of dinutuximab (Unituxin) for neuroblastoma. As more vouchers have been awarded over time, reported per-voucher prices have generally trended down from that peak, though individual transactions still vary considerably.

Current program status

The rare pediatric disease PRV program has been reauthorized multiple times rather than made permanent. It lapsed briefly at the end of 2024 — FDA could not award new vouchers under it after December 20, 2024 — before the Consolidated Appropriations Act, 2026 (enacted February 2026) reauthorized the program, extending FDA’s authority to award new rare pediatric disease vouchers through September 30, 2029. Anyone assessing whether a program in development could still qualify should check the current statutory sunset date directly against FDA’s program page rather than assume indefinite availability, given this history of lapses and reauthorizations. The tropical disease PRV program, established in 2007, has continued without a comparable sunset provision.

How a PRV differs from orphan drug designation

A PRV is easy to conflate with orphan drug designation, but the two are distinct mechanisms that can apply to the same product at different points. Orphan drug designation is requested and granted during development, based on prevalence and scientific rationale, and confers development-stage incentives (tax credits, fee waivers, market exclusivity on approval). A PRV, by contrast, is only awarded at approval, for a narrower subset of rare-pediatric or tropical-disease products, and its main value is a transferable regulatory asset rather than a development-stage incentive. A product can hold orphan drug designation and never generate a PRV (if it isn’t a qualifying pediatric or tropical disease product), and conversely the rare pediatric disease PRV criteria are not identical to orphan disease prevalence criteria, though the two populations overlap substantially in practice.

Why this matters for research administration

For a research administrator or regulatory affairs office supporting a sponsor-investigator or spin-out with a pediatric or tropical disease candidate, PRV eligibility is a real, quantifiable development incentive worth tracking alongside orphan drug and rare pediatric disease designation requests — it can materially change the return calculation for a small institution or company that would otherwise have no near-term use for accelerated review on its own pipeline, since the voucher itself can be sold. It is not, however, a substitute for a scientifically sound priority-review case: the underlying application still has to meet FDA’s substantive approval standards, and the voucher accelerates only the review clock, not the bar for approval.