Chairman Guthrie Celebrates House Passage of Mikaela Naylon Give Kids A Chance Act
WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued a statement following the House passage of H.R. 1262, the Mikaela Naylon Give Kids a Chance Act— a bipartisan piece of legislation which reauthorizes the FDA’s Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) Program to incentivize the development of treatments for rare pediatric diseases, and authorizes the FDA to direct companies to study a combination of cancer drugs and therapies in pediatric trials. “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 reauthorization of the Rare Pediatric Disease Priority Review Voucher Program has led to over 50 new treatment approvals for nearly 40 different rare pediatric diseases, many of which had no options prior. The impact of this program is profound for patients, and I am grateful to the sponsors of this legislation and their commitment to promoting research and addressing gaps in pediatric therapeutics.” Background on H.R. 1262: H.R. 1262 , the Mikaela Naylon Give Kids a Chance Act , is a comprehensive piece of legislation that increases access to innovative treatments for children by: Reauthorizing the FDA Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) Program through Fiscal Year 2029 and clarifies that orphan drug exclusivity applies to the approved indication, rather than the potentially broader designation; Providing the Food and Drug Administration (FDA) with additional authority to require pediatric cancer trials for new combinations of drug therapies; Authorizing the FDA to take enforcement action against companies that fail to meet pediatric study requirements under the Pediatric Research Equity Act (PREA); Directing the FDA to establish an office in an Abraham Accord country to enhance facilitation with the agency; and Requiring 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. ###