Give Kids a Chance Act of 2025

The Mikaela Naylon Give Kids a Chance Act was signed into law on February 3, 2026! This moment is a result of our community's collective, relentless advocacy, and it means that more children will have a chance to beat cancer and live long, healthy lives.

There are close to 7,000 rare “orphan” diseases without appropriate treatments, and the vast majority affect children. Despite the significant unmet need for new FDA-approved pediatric cancer therapies, pharmaceutical companies have been reluctant to develop new pediatric oncology drugs since they likely will not recoup the high costs associated with their research, development, marketing, and distribution following approval. As a result, a unique blend of federal incentives and requirements — “carrots and sticks”— are needed to usher in the next generation of newer, less toxic treatments for kids.

The Mikaela Naylon Give Kids a Chance Act of 2025 addresses some of the most pressing research needs of children and families with cancer, including extending vital research incentives, ensuring children with cancer continue to have access to the newest cures, and guaranteeing pediatric studies happen in a timely manner. The bill expands on multiple landmark rare disease laws to reflect the changing landscape of pediatric drug development.

It includes provisions of the Innovation in Pediatric Drugs Act, which gives FDA the authority to penalize drug companies that do not fulfill their pediatric study requirements -- a long-standing priority of Children's Cancer Cause.

This bill was introduced in the House in February 2025 by Rep. Michael McCaul alongside Representatives Gus Bilirakis (R-Fla.), Debbie Dingell (D-Mich.), Kim Schrier (D-Wash.), Diana Harshbarger (R-Tenn.), Kathy Castor (D-Fla.), Mike Kelly (R-Pa.), Doris Matsui (D-Calif.), Dan Crenshaw (R-Texas), Lori Trahan (D-Mass.) and Randy Weber (R-Texas). In the Senate, the bill was introduced in March 2025 by Senators Markwayne Mullin (R-Oklahoma) and Michael Bennett (D-Colorado).