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H.R. 10359House119th Congress (2025-2027)In Committee

Priority for Pediatric Cures Act

Sponsored by Gus M. BilirakisRep. Gus M. Bilirakis (R-FL)
Introduced September 14, 2026

AI-Generated Summary

Updated September 17, 2026 at 4:43 AM UTC

The Priority for Pediatric Cures Act changes the federal drug law to make the program that lets the Health and Human Services Secretary give out priority‑review vouchers for medicines that treat rare pediatric diseases a permanent feature. By doing so, it keeps the incentive that speeds up FDA review for these drugs, helping companies that develop treatments for children with rare conditions.

Key Provisions

  • Amends Section 529(b) of the Federal Food, Drug, and Cosmetic Act by deleting paragraph (5), which had limited the Secretary’s authority to award priority‑review vouchers; the deletion makes the voucher authority indefinite.

Legislative Activity

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HouseIntro Referral Latest Action

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

September 14, 2026

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HouseIntro Referral

Introduced in House

September 14, 2026

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

September 14, 2026

Bill Text

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Introduced in HouseIssued September 14, 2026

I

119th CONGRESS

2d Session

H. R. 10359

IN THE HOUSE OF REPRESENTATIVES

September 14, 2026

Mr. Bilirakis (for himself, Ms. Barragán, Mrs. Cammack, Mr. Auchincloss, Mr. Kean, and Mr. Mullin) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to permanently extend the authority of the Secretary of Health and Human Services to award priority review vouchers for rare pediatric disease products.

1.

Short title

This Act may be cited as the Priority for Pediatric Cures Act.

2.

Permanent extension of authority to award priority review vouchers for rare pediatric disease products

Section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking paragraph (5).