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Committee advances Give Kids a Chance Act to accelerate pediatric rare disease treatments; PRV reauthorized
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Summary
The House Energy and Commerce Committee voted to advance HR 1262, the Give Kids a Chance Act, reauthorizing the FDA rare pediatric disease priority review voucher program and other measures to speed pediatric cancer and rare disease research and access.
The House Energy and Commerce Committee voted to advance HR 1262, the Give Kids a Chance Act of 2025, reauthorizing the Food and Drug Administration's rare pediatric disease priority review voucher (PRV) program and adding authorities intended to accelerate pediatric cancer trials.
Representative Doris Matsui (D-Calif.), a co-leader on the measure, said the bill will "give kids a fighting chance," emphasizing that the PRV program has led to approvals for dozens of pediatric treatments since 2012. Representative Gus Bilirakis (R-Fla.), a co-sponsor, said the program has produced lifesaving therapies and urged swift House action.
Committee members from both parties described personal and constituent experiences that, they said, underline the urgency. "This bill ensures kids are not left behind when it comes to medical innovation," Representative Dan Crenshaw (R-Texas) said, noting delays in pediatric trials when drugs are developed first for adults.
The markup included an amendment in the nature of a substitute offered by Representative Dunn to add transparency provisions for generic drugs; committee leadership said that language clarifies regulatory pathways to increase access to lower-cost generics alongside the pediatric measures. Representative Castor offered, and later withdrew, a separate amendment to the bill’s aims seeking to bar administration changes to immunization schedules that would reduce covered vaccines; her amendment prompted an extended debate about vaccine advisory processes before she withdrew it.
On the final roll call, the committee agreed to the bill as amended. The clerk reported 47 ayes and 0 nays on passage of HR 1262 in committee.
Why it matters: Sponsors and supporters said reauthorizing the PRV program incentivizes private-sector investment in treatments for rare pediatric diseases without direct new federal spending. Supporters argued the change shortens timelines for children to access therapies and retains U.S. leadership in biopharma innovation.
What's next: The bill will proceed to the House floor after committee work; sponsors urged quick action to deliver grants and incentives that they say families now waiting for treatments have long sought.
