WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued a statement after President Trump signed H.R. 7148 into law this week, which included the Mikaela Naylon Give Kids a Chance Act.

“H.R. 1262, the Mikaela Naylon Give Kids a Chance Act, builds on current programs to accelerate research and drug development for rare pediatric diseases, including cancer,” said Chairman Guthrie. “The bill reauthorized the Rare Pediatric Disease Priority Review Voucher Program that has led to over 50 new treatment approvals for nearly 40 different rare pediatric diseases, many of which had no treatment options prior to the existence of the program. The positive impact is profound for patients, and I am grateful to the many champions of this legislation and their commitment to promoting research and addressing gaps in pediatric therapeutics.”

Background:

• H.R. 1262, the Mikaela Naylon Give Kids a Chance Act, was reported to the full House from the Committee on Energy and Commerce, as amended, by a vote of 47 yeas and 0 nays and passed the full House by voice vote.
• H.R. 1262 was incorporated into H.R. 7148, the Consolidated Appropriations Act of 2026, which was passed by the full House on February 3, 2026, and signed into law by President Trump.

The Mikaela Naylon Give Kids a Chance Act:

• Reauthorizes the FDA Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) Program through Fiscal Year 2029;
• Provides the Food and Drug Administration (FDA) with additional authority to require pediatric cancer trials for new combinations of drug therapies;
• Authorizes the FDA to take enforcement action against companies that fail to meet pediatric study requirements under the Pediatric Research Equity Act (PREA);
• Directs the FDA to establish an office in an Abraham Accord country 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 or qualitatively different from the listed drug, speeding up patients access to more affordable medications.

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