The Innovation in Pediatric Drugs Act is a bipartisan bill introduced in the Senate (S.705) in February 2025 that would strengthen the development of childhood cancer drugs. We thank Senators Jack Reed and Shelley Moore Capito for their leadership as sponsors of this bill, which will help speed therapies to children who need them by making needed changes to pediatric drug laws.

For the past several years, Children’s Cancer Cause has advocated that the FDA have the same authority to penalize companies who fail to complete required studies for pediatric drugs as they currently have for studies of adult drugs. The Innovation in Pediatric Drugs Act strives to achieve that equity.

There are close to 7,000 rare diseases without appropriate treatments, and the vast majority of these diseases affect children. Unfortunately, in most cases, drugs for rare diseases, also known as orphan drugs, are not required to be studied in children. Yet the majority of new drugs approved are orphan drugs, meaning that the majority of newly approved drugs are exempt from pediatric study requirements, leaving doctors, parents, and sick kids in the dark about possible treatments.

The Innovation In Pediatric Drugs Act of 2023 would make needed improvements to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) and builds upon the promise of the Research To Accelerate Cures and Equity (RACE) Act.

In the last Congress, provisions of this bill passed the U.S. House as part of a larger legislative package of pediatric drug development bills but it failed to advance in a year-end package. Please join us in asking your Members of Congress to support this bill in the 119th Congress.