Priority Review Voucher Programs Poised For US Legislative Attention In 2020

18 Feb 2020

Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.

Priority Fast Lane Sign Airport First Class Luxury Notification Blue Light — US FDA seeks statutory clarity on biologics eligible for priority review vouchers. • Source: Shutterstock

The US Food and Drug Administration’s priority review voucher programs appear poised for legislative attention this year, with the rare pediatric disease program due to sunset in September and the agency itself calling on Congress to clarify what types of biologic products are eligible for vouchers.

In addition, a recent Government Accountability Office report suggests potential legislative and regulatory changes across the voucher programs, which remain...