August 10, 2023 - 2:00 PM - 3:00 PM ET

Venable LLP

Current Issues in FDA Priority Review Voucher Programs

This event has already occurred.


What is a Priority Review Voucher (PRV)? A PRV is a regulatory incentive, issued by the Food and Drug Administration (FDA), that guarantees the recipient priority review (a six-month review clock) for a future product application. Congress created PRV programs to incentivize the development of novel drugs and biologics to treat listed tropical diseases, rare pediatric diseases, and material threats to public health or national security. Once the PRV is awarded, the recipient has two options for using the voucher: (1) the PRV may be applied by the recipient company to any subsequent qualifying FDA application; or (2) the recipient may sell the PRV to another company, which may then use it on its own subsequent application. More than 20 PRVs have been sold to date, with sale prices ranging from $53 million to $350 million, providing a strong incentive in areas where there would otherwise be little return on investment. Each of the three PRV statutes is distinct, with specific eligibility criteria that product sponsors must understand. This webinar provides an overview of each PRV program, tips on determining eligibility, valuation of PRVs, best practices for navigating partnering agreements where a potential PRV sale is contemplated, and highlights of important developments in the U.S. Congress that could impact the reauthorization of these powerful incentive programs.


Jeremiah Kelly, Partner, Venable LLP
Justin Coen, Partner, Venable LLP
Richard Starr, Associate, Venable LLP