Congressional Correction: FDA Rare Pediatric Disease Priority Review Voucher Program Reauthorized Through September 2029 Under Consolidated Appropriations Act 2026
A factual correction on the Rare Pediatric Disease Priority Review Voucher (PRV) program timeline: the Consolidated Appropriations Act 2026, signed by President Trump on February 3, 2026, reauthorized the RPD PRV program through September 2029, materially reducing the sunset risk that had shadowed rare-disease commercial modeling. The reauthorization was passed via the Mikaela Naylon Give Kids a Chance Act embedded in the CAA and covers all rare pediatric disease sponsors submitting NDAs and BLAs during the reauthorization window. Since program launch in 2012, 63 RPD PRVs have been awarded across 47 rare diseases from Duchenne muscular dystrophy to hemophilia A. Recent PRV secondary-market pricing has ranged from $67 million (2015 low) to $350 million (2015 high), with recent transactions clustered in the $100-250 million range. Arrowhead sold a PRV for $215 million alongside the plozasiran FCS approval earlier in 2026, and Ionis Pharmaceuticals received a PRV alongside the September 3 Zanvastro (zilganersen) Alexander disease approval. The reauthorization also amends the Orphan Drug Act to clarify that orphan drug exclusivity applies to the FDA's approved use or indication within a rare disease rather than the entire rare disease.