New Bill to permanently authorize the rare pediatric disease priority review voucher program
Congress Representative Gus M. Bilirakis with bipartisan support, has introduced the Priority for Pediatric Cures Act, seeking to PERMANENTLY authorize the Rare Pediatric Disease Priority Review Voucher program.
Since the programs' introduction in 2012, the program has been extended four times with the current iteration due to end in September 2029 and has led to >75 new treatments for rare pediatric diseases.
Please find below excerpts from the proposed Act alongside the corresponding wording in the current legislation.
H.R.10359 - Priority for Pediatric Cures Act
Section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5).
Section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b))
(5) Termination of authority
The Secretary may not award any priority review vouchers under paragraph (1) after September 30, 2029
The timelines are not yet clear when the Bill is likely to pass through Congress and the Senate. You can follow me on socials or sign up for updates on this page to stay in the loop.
