The U.S. House of Representatives on Dec. 1 unanimously passed landmark legislation proposed by U.S. Rep. Michael McCaul (R-TX) that aims to hasten pediatric cancer treatments and expand access to therapies for children battling rare diseases.
The bipartisan Give Kids A Chance Act of 2025, H.R. 1262, 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.
“As a founder of the childhood cancer caucus, I’ve met with countless cancer patients and advocates who have asked me for one thing: to give kids their best chance of beating cancer,” Rep. McCaul said on Monday. “The House of Representatives shined a beacon of hope for those children and their families by unanimously passing the Mikaela Naylon Give Kids A Chance Act.”
Rep. McCaul sponsored H.R. 1262 on Feb. 12 alongside 10 original cosponsors, including U.S. Reps. Debbie Dingell (D-MI) and Mike Kelly (R-PA). The bill, which currently has 313 cosponsors, advanced to the U.S. Senate for consideration on Tuesday.
Once in the Senate, U.S. Sen. Markwayne Mullin (R-OK) renamed the bill to the Mikaela Naylon Give Kids a Chance Act in honor of Naylon, an American teenager with osteosarcoma who spent nearly six years traveling across the country pursuing treatment, while also advocating for other children with cancer. Naylon died on Oct. 29 at age 16.
“Mikaela represents all the children who have advocated for this bill and suffered with this heartbreaking disease,” said Rep. McCaul. “Losing some of these kids has been the hardest part of my career, but today, I’m encouraged because I know Mikaela’s legacy — and all of their legacies — will live on in this bill forever and help save countless lives.”
If enacted, the measure would expand the Food and Drug Administration’s (FDA’s) authority with respect to research on rare pediatric diseases, including by permitting the FDA to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements and by reauthorizing programs that support pediatric research.
The bill also would reauthorize the FDA priority review voucher (PRV) program, which allows pharmaceutical companies to expedite FDA review of more profitable drugs in return for developing treatments for rare pediatric diseases, among other provisions.
“Children respond to cancer treatments differently than adults, but there is not enough research to fully understand how therapies impact them,” said Rep. Dingell. “This bill will expand pediatric cancer research, offering more children a fighting chance.”