Urge Congress to Make Kids with Cancer a Priority with the “Childhood Cancer Package”

Please join us in urging Congress to pass the “Childhood Cancer Package” - the Accelerating Kids’ Access to Care Act (H.R.1509/S.752) and the Mikaela Naylon Give Kids a Chance Act (H.R.1262) - in any January spending package.

It is more critical than ever that Congress prioritize the needs of children with cancer and their families by passing these two critical childhood cancer bills related to pediatric drug development, clinical trials, and access to care.

Both bills were included in the 118th Congress bipartisan negotiated end-of-year deal but never received a vote.

Together, these bills represent the most influential childhood cancer legislation in over a decade.

Read on to learn the details of these crucial bipartisan bills that, together, make up the Childhood Cancer Package. We need every passionate voice in the childhood cancer community speaking up to help secure their passage before the current Continuing Resolution runs out on January 31st, 2026.

Improving the “Carrots and Sticks” of Pediatric Drug Development 

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. 

H.R. 1262, 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. Under the Pediatric Research Equity Act (PREA), drug companies are required to study adult drug indications in children when children could benefit from pediatric studies. Unfortunately, FDA’s existing authorities to enforce required post-market pediatric study deadlines have proven insufficient, as many required post-market pediatric studies are still delinquent years later. Current law allows FDA to assess civil monetary penalties for late post-market study requirements for adults, but exemptions under PREA forbid FDA from doing the same for children. The Mikaela Naylon Give Kids a Chance Act would give FDA the tools it needs to ensure these deadlines are met, and children with cancer can benefit from potential new, less toxic treatments.  

The Orphan Drug Act (ODA) is landmark legislation that has impacted pediatric drug development. Since the ODA was enacted into law in 1983, Congress has interpreted its exclusivity to apply only to the approved indication within a rare disease or condition rather than the initial designation. Unfortunately, due to a recent court decision1, Congress and FDA’s longstanding interpretation of the ODA has been materially weakened and is now at risk of locking children out of newly approved drugs that don’t impact pediatric populations. The Mikaela Naylon Give Kids a Chance Act would codify Congress’ interpretation of the ODA as it was initially intended. 

Since 2012 the FDA priority review voucher program has been a critical incentive for pharmaceutical manufacturers to invest in drugs with indications for rare pediatric diseases. Through this program, FDA has awarded vouchers that offer new hope for children with cancer. Unfortunately, due to congressional inaction, this program expired at the end of 2024. The Mikaela Naylon Give Kids a Chance Act of 2025 would reauthorize the rare pediatric disease priority review voucher program until 2029. 

The Mikaela Naylon Give Kids a Chance Act of 2025, which enjoys 313 bipartisan cosponsors in the House, unanimously passed the U.S. House of Representatives on December 1st, 2025. 

Cutting Red Tape to Treat Children Without Delay 

Every child facing a health crisis deserves access to the treatment they need. However, many children live in states where specialized care is not available locally. Even some states with leading medical centers lack health providers with expertise in rare conditions. As a result, children with complex medical needs like cancer often must travel outside their states to receive treatment. This might include travel to participate in a clinical trial, which, for many kids, offers the best treatment available.  

More than half of children in the U.S. rely on Medicaid and the Children’s Health Insurance Program (CHIP) for their health insurance coverage. But bureaucratic rules in these programs often limit kids’ ability to get timely treatment outside their home state.  

Today, if a child’s condition requires treatment from an out-of-state provider, that provider – or sometimes the entire care team – must go through a lengthy enrollment process with the child’s home state Medicaid program. This paperwork can take months, leaving children desperately waiting for care. This process needlessly results in delays in treatment that can cause a child's condition to worsen.  

For children facing a cancer diagnosis or relapse, every minute matters. In fact, pediatric cancers are often treated as emergencies, with families frequently urged to initiate treatment as quickly as possible. 

H.R. 1509/S. 752, the Accelerating Kids’ Access to Care Act, can help eliminate these delays. This bill allows pediatric providers to enroll more efficiently in multiple state Medicaid programs for a five-year period, allowing them to provide essential, time-sensitive care to children who need it.  

Simply put, the Accelerating Kids’ Access to Care Act will ensure better, faster healthcare for kids who need it most by reducing the burden on the doctors who treat them.  

The bill was included in the House-passed version of H.R. 1, the One Big Beautiful Bill Act and enjoys over 40 bipartisan cosponsors in the Senate.