> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# House OKs Rare Pediatric Disease Voucher Program
- URL: https://www.fdaweb.com/house-oks-rare-pediatric-disease-voucher-program/
- Published: 2025-12-02T12:00:00.000Z
- Updated: 2026-09-14T15:28:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160307

The House has approved the Mikaela Naylon Give Kids a Chance Act, which reauthorizes FDA’s Rare Pediatric Disease Priority Review Voucher program. House Energy and Commerce Committee chairman **Brett Guthrie** (R-KY) [says](https://energycommerce.house.gov/posts/chairman-guthrie-celebrates-house-passage-of-mikaela-naylon-give-kids-a-chance-act?ref=fdaweb.com) in a committee statement that the bill “builds on current programs to accelerate research and drug development for rare pediatric diseases, including cancer.” The bill was named in honor of **Mikaela Naylon**, a young woman who courageously advocated for its passage throughout her fight with cancer.

The statement gives this background on the bipartisan legislation:

- reauthorizes the Rare Pediatric Disease Priority Review Voucher program through FY 2029 and clarifies that orphan drug exclusivity applies to the approved indication, rather than the potentially broader designation;
- gives FDA additional authority to require pediatric cancer trials for new combinations of drug therapies;
- authorizes the agency to take enforcement action against companies that fail to meet pediatric study requirements under the Pediatric Research Equity Act;
- directs FDA to establish an office in an Abraham Accord country (Israel, the United Arab Emirates, Bahrain, or Morocco) to enhance facilitation with the agency; and
- requires FDA to disclose to certain generic drug applicants if any ingredients cause a drug to be quantitatively and qualitatively different from the listed drug, speeding patient access to more affordable medicines.