Before and After: Have Rare Pediatric Disease Priority Review Vouchers Helped Drug Development?
June 23, 2026
Type: Breakout Session
Focus Area:
Orphan and Rare Disease
Congress created the Rare Pediatric Disease Priority Review Voucher (PRV) program to incentivize the development of drugs for serious or life-threatening rare diseases in children. Vouchers are earned by companies that develop a rare disease drug for kids. The vouchers are transferable and entitle the holder to a priority FDA review for a subsequent product application. This incentive regularly faces legislative uncertainty, risking expiration when Congress does not act to renew its authority. The most significant lapse in the history of the program began in late 2024.
This panel, convening patient advocacy and industry experts, will conduct a balanced assessment of the PRV program's outcomes, consider operational challenges, and explore whether legislative action is needed to ensure continued innovation for pediatric rare disease communities.
Moderator
Speakers
Senior Vice President, Federal Government Relations
Biotechnology Innovation Organization (BIO)


