HHS Lends Support to Stalled "Give Kids a Chance" Legislation

Federal Advocacy,

The U.S. Department of Health and Human Services (HHS) has formally lent its support to the Give Kids A Chance Act - landmark legislation designed to accelerate pediatric cancer research and expand access to life-saving therapies for children affected by rare diseases. HHS’s endorsement comes at a critical juncture as the bill remains stalled in the Senate despite broad bipartisan backing in the House.  

The Give Kids A Chance Act of 2025 (H.R. 1262), also known as the Mikaela Naylon Give Kids A Chance Act, would reauthorize the FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) Program, strengthen pediatric drug research pathways, and grant the U.S. Food and Drug Administration (FDA) additional authority to require combination cancer drug trials for children - a strategy experts say could uncover new, more effective treatments.  

Background on the Legislation: 
  • What it does: The bill would reauthorize and improve key pediatric research incentives — including reauthorizing the Rare Pediatric Disease PRV program, enhancing enforcement of pediatric study requirements, and promoting research into combinations of cancer drugs for pediatric use.  

  • House action: The House unanimously passed the bill in December 2025, a rare example of bipartisan unity on health policy — underscoring both its urgency and broad appeal. 

  • Current status: The Senate has yet to pass the bill into law, leading HHS and childhood cancer advocacy groups to urge swift action.  

Children with cancer and rare diseases face unique treatment challenges. While thousands of new therapies are developed for adults, pediatric research lags behind, in part due to smaller markets and higher regulatory hurdles. The Give Kids A Chance Act aims to close that gap by incentivizing investment and giving regulators more tools to ensure that promising treatments reach young patients.  

HHS’s support signals federal recognition that re-energizing pediatric research incentives is not only a public health priority but also a driver of clinical innovation with life-changing implications for families.  

MichBio has been a strong advocate for the bill, highlighting its importance for biotech innovation and the patients served by Michigan’s life sciences community. MichBio’s advocacy includes encouraging support among members of Congress and raising awareness of the legislation’s potential to catalyze industry investment in pediatric therapeutics.  

Members of Michigan’s U.S. House delegation who have shown support include: Rep. Debbie Dingell (D-MI-6) - Cosponsor of the legislation and a vocal advocate for expanding pediatric cancer research, along with Reps. Bergman, Moolenaar, Scholten, Huizenga, Walberg, Stevens, McDonald Rivet, Tlaib, and Thanedar. 

MichBio continues to engage and support both delegates, emphasizing how the legislation aligns with Michigan’s industry priorities and the needs of patients and families across the state.  

The Give Kids A Chance Act represents a major opportunity to reinvigorate pediatric cancer and rare disease research through proven, cost-effective policy tools. With HHS’s recent endorsement and continued advocacy from industry stakeholders like MichBio and members of Michigan’s delegation, momentum is building for Senate passage - a critical step toward giving children battling serious illness a fighting chance.