A priority review voucher is a transferable certificate the FDA gives a drug company when it wins approval for a treatment in one of three qualifying disease categories. The voucher shortens the FDA’s review clock on a future drug application from ten months to six. The company that earned it can redeem it, sell it to another company, or transfer it again after that, with no cap on how many hands it passes through before someone uses it.
That four-month head start can be worth hundreds of millions in early revenue for a blockbuster product, which is why vouchers trade on an active secondary market at prices that have ranged from roughly $21 million to $350 million.
What the Voucher Does at the FDA
Redeeming a voucher cuts the FDA’s review goal on a new drug application or biologics license application from ten months to six.1U.S. Food and Drug Administration. Priority Review One limitation matters up front: a voucher does nothing for an application that already qualifies for priority review on its own. It only speeds up products that would otherwise sit on the standard ten-month timeline.2U.S. Food and Drug Administration. Tropical Disease Priority Review Voucher Program
Two steps govern the redemption itself. First, the sponsor must notify the FDA of its intent to use the voucher at least 90 days before submitting the drug application, and the notification has to name the intended submission date. If the schedule slips, the sponsor withdraws the original notice and files a new one with an updated date at least 90 days out. Submitting the application earlier than the date in the notification is grounds for rejection.3Food and Drug Administration. Guidance for Industry – Rare Pediatric Disease Priority Review Vouchers
Second, the sponsor owes a separate priority review voucher fee on top of the standard application fee. The FDA recalculates this fee each fiscal year based on the difference between the average cost of a priority review and a standard review, and it publishes the rate in the Federal Register. The voucher fee is not eligible for waivers, exemptions, or refunds, and an application submitted with unpaid fees is treated as incomplete.4Federal Register. Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026
How a Company Earns One
Federal law creates three separate paths to earning a voucher, each aimed at a category of disease where the ordinary commercial market would not support enough research.
Tropical Diseases
Section 524 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 360n, covers drugs for diseases that disproportionately affect populations in developing countries. The statute lists qualifying conditions including tuberculosis, malaria, cholera, dengue, leishmaniasis, and schistosomiasis, and the Secretary of Health and Human Services can add other infectious diseases that lack a significant market in developed nations and disproportionately affect poor and marginalized populations.5Office of the Law Revision Counsel. 21 USC 360n – Priority Review to Encourage Treatments for Tropical Diseases
Rare Pediatric Diseases
Under 21 U.S.C. § 360ff, a voucher can be earned for a drug treating a serious or life-threatening disease whose worst manifestations primarily affect people from birth through age 18. The condition also has to qualify as a “rare disease” under the Orphan Drug Act, meaning fewer than 200,000 people in the United States have it overall.6Office of the Law Revision Counsel. 21 USC 360ff – Priority Review to Encourage Treatments for Rare Pediatric Diseases A company has to request and receive a rare pediatric disease designation from the FDA before submitting its marketing application. The agency will not grant the designation retroactively once the application is already in.3Food and Drug Administration. Guidance for Industry – Rare Pediatric Disease Priority Review Vouchers
Medical Countermeasures
Under 21 U.S.C. § 360bbb-4a, added by the 21st Century Cures Act of 2016, drugs meant to treat or prevent harm from biological, chemical, radiological, or nuclear threats to national security also qualified.7Office of the Law Revision Counsel. 21 USC 360bbb-4a – Priority Review to Encourage Treatments for Agents That Present National Security Threats The FDA lost authority to award new medical countermeasure vouchers after October 1, 2023. Vouchers issued before that date can still be redeemed and transferred.8U.S. Food and Drug Administration. 21st Century Cures Act – MCM-Related Cures Provisions
What the Qualifying Application Has to Show
Targeting the right disease is not enough on its own. The qualifying application has to include at least one new clinical investigation that was essential to approval and was conducted or sponsored by the applicant. A submission that relies entirely on published literature or someone else’s studies will not earn a voucher.9Food and Drug Administration. Tropical Disease Priority Review Vouchers – Guidance for Industry The drug also has to earn priority review for the qualifying application on its own merits, meaning it represents a significant improvement over existing treatments or addresses a condition with no adequate therapy.
Which Programs Are Still Active
The three programs run on different clocks. Medical countermeasure vouchers are no longer being issued. The rare pediatric disease program is authorized through September 30, 2029, following reauthorization in the Consolidated Appropriations Act of 2026.10U.S. Food and Drug Administration. Rare Pediatric Disease Designation and Priority Review Voucher Programs The tropical disease program is the only one Congress wrote without a sunset provision and remains open indefinitely unless future legislation changes that.2U.S. Food and Drug Administration. Tropical Disease Priority Review Voucher Program
These dates feed directly into secondary-market pricing. When the rare pediatric program looked like it might expire without reauthorization, sale prices climbed as buyers braced for a shrinking supply.
Selling and Transferring a Voucher
All three programs let the original recipient sell or transfer the voucher, and there is no cap on how many times it can change hands before someone redeems it.6Office of the Law Revision Counsel. 21 USC 360ff – Priority Review to Encourage Treatments for Rare Pediatric Diseases The FDA plays no role in setting prices or approving the deal.
Prices have swung widely with supply and demand. The lowest recorded sale was $21.2 million, paid by Novartis in 2023. The highest was $350 million, paid by AbbVie in 2015. Recent deals have clustered in the $150 million to $180 million range, pushed up in part by concerns about expiring programs. Ipsen sold a rare pediatric disease voucher for $158 million in 2024, and Rocket Pharmaceuticals sold one for $180 million after approval of its gene therapy.
The buyer, not the seller, has to notify the FDA of the change in ownership within 30 days of each transfer. The notification should include documentation from both parties acknowledging the deal.6Office of the Law Revision Counsel. 21 USC 360ff – Priority Review to Encourage Treatments for Rare Pediatric Diseases Once the FDA has the new owner on record, that owner holds the same redemption rights as the original recipient.9Food and Drug Administration. Tropical Disease Priority Review Vouchers – Guidance for Industry
Tax Treatment for Buyers and Sellers
Tax treatment of a voucher sale does not have a clean public answer. In a 2023 Chief Counsel Advice memorandum, the IRS characterized a purchased voucher held for resale or investment as a “separate and distinct intangible asset.” The memorandum indicated that a company holding a voucher for resale cannot amortize the cost under standard depreciation rules and instead recovers its basis through the gain or loss recognized when it sells. Chief Counsel Advice memoranda cannot be cited as precedent, so treatment can vary with the facts of a given transaction. At the prices these vouchers command, both buyers and sellers should plan for this to be a meaningful tax question.