The FDA's Priority Review Voucher Program: Potential Benefits and Risks for Manufacturers and Outlook for Future Use

The FDA’s Priority Review Voucher (PRV) program was designed to incentivize the creation of medications for unmet needs and underserved disease areas.

With PRVs averaging a sales price of over $100 million and a record high sales price of $350 million, this program offers a substantial incentive for the development of medications for three underserved categories: tropical diseases, rare pediatric diseases, and medical countermeasures. The redemption of a PRV may result in benefits to drug manufacturers that include generating revenue 4 months sooner on a drug and/or earning 4 months of additional revenue prior to generic entry, potentially beating a competitor to the market, and getting a drug approved and on payer formularies by the beginning of the year.

In this paper, we evaluate the benefits of using a PRV through three case studies, assess potential return-on-investment (ROI) calculations, provide a summary of PRVs sold to date, and assess how PRVs may be utilized in the future.