Rare Disease Vouchers Caught in Political Abyss: Recent Updates on Reauthorization Efforts
The FDA’s rare pediatric disease priority review voucher (PRV) program lapsed at the end of 2024 after being stripped from a continuing resolution despite unanimous support in the 118th Congress.1
The Mikaela Naylon Give Kids a Chance Act of 2025 seeks to reauthorize the PRV program through September 30, 2029, and was advanced by the House Energy and Commerce Committee.123
The U.S. House passed a $1.2 trillion spending bill including PRV reauthorization with a 340–88 vote, now awaiting Senate approval expected next week after January 21, 2026.2
Senator Bernie Sanders blocked a prior reauthorization attempt in late December by linking it to broader healthcare reforms opposed by Republicans like Sens. Mullin, Cassidy, and Hassan.16
Advocates including the Rare Disease Company Coalition (RDCC) and executives from Solid Biosciences, SynaptixBio, and BridgeBio urge longer authorization periods (7–10 years) to match rare disease development timelines and provide investment stability.13
Sources:
1. https://www.biospace.com/policy/rare-disease-vouchers-caught-in-political-abyss-it-didnt-have-to-be-this-way
2. https://www.biospace.com/policy/rare-pediatric-disease-vouchers-pbm-reform-up-for-vote-in-house
3. https://www.rarecoalition.com/category/press-releases/
6. https://trial.medpath.com/news/0cb4cd379cedfec2/rare-pediatric-disease-voucher-program-faces-uncertain-future-as-congressional-reauthorization-stalls