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Akin Gump

| less than a minute read

Congress Rallies to Extend Rare Pediatric Disease Priority Review Voucher Program

On February 3, 2026, the Consolidated Appropriations Act, 2026 (P.L. 119-75) became law and marked an important milestone in the bipartisan congressional effort to reauthorize the rare pediatric disease priority review voucher program. Section 6604 of this law extends the Food and Drug Administration’s (FDA) authority to issue priority review vouchers to encourage treatments for rare pediatric diseases through September 30, 2029. While the extension of this authority provides certainty to this program for the next few years, newly enacted reporting provisions included with the extension also set the stage for continued assessments of the impact of this program. Section 6604 requires the Government Accountability Office (GAO) to study and submit a report to Congress on the effectiveness of awarding rare pediatric disease priority vouchers in the development of products that treat or prevent rare pediatric diseases not later than five years after the enactment of this provision.