U.S. Rep. Michael McCaul (R-TX) has introduced bipartisan legislation to hasten pediatric cancer treatments and expand access to therapies for children battling rare diseases.
“No child should have to battle cancer, especially without access to the most advanced treatments available,” Rep. McCaul, founder and co-chair of the Congressional Childhood Cancer Caucus, said on Feb. 12. “We have made great strides in pediatric drug development, but there is still work to be done.”
The Give Kids a Chance Act of 2025, H.R. 1262, which has 10 original cosponsors, including U.S. Reps. Mike Kelly (R-PA) and Debbie Dingell (D-MI), would combine two initiatives — the original Give Kids a Chance Act and the Creating Hope Reauthorization Act — to spur drug development for pediatric rare diseases, improve outcomes for patients, and close gaps in pediatric drug research for the nearly 16,000 children in the United States who are diagnosed with cancer each year.
“As a longtime advocate for pediatric cancer research, I am proud to reintroduce this legislation, which builds on the success of the Creating Hope Act to further incentivize drug development for children battling rare and deadly diseases and give every child a fighting chance,” Rep. McCaul said.
Rep. Dingell pointed out that while researchers know that children respond differently to cancer treatments, there’s limited research on how these therapies impact them. “This bill will expand pediatric cancer research, offering more children a fighting chance,” she said.
Specifically, H.R. 1262 would reauthorize the Food and Drug Administration (FDA) priority review voucher (PRV) program — originally created under Rep. McCaul’s Creating Hope Act — which allows pharmaceutical companies to expedite FDA review of more profitable drugs in return for developing treatments for rare pediatric diseases.
Since the bill’s passage in 2011, 53 PRVs have been awarded for 35 different rare pediatric diseases, according to a bill summary provided by Rep. McCaul’s staff.
“I urge my colleagues in Congress to pass this bill swiftly and provide hope to families across the country as we continue working to beat cancer once and for all,” said the congressman.