Give Kids a Chance Act of 2025

This bill aims to get better treatments to children faster. It strengthens FDA rules for pediatric cancer drug studies, including allowing some studies that combine a new drug with certain already‑approved ingredients, and it requires useful data by age group. It also lets the FDA decide early which pediatric rules apply to a drug application. If a company fails to do required pediatric studies and shows a lack of effort, the FDA can take action after giving a 45‑day chance to respond; this does not apply to products no longer sold, and these enforcement powers start 180 days after the law takes effect .

The bill extends the “priority review voucher” program for rare pediatric diseases through September 30, 2029, sets when voucher fees are due, and orders a federal study to check if the program truly speeds up treatments for kids with rare diseases . It clarifies that seven‑year market exclusivity for rare‑disease (“orphan”) drugs blocks approval of the same drug only for the same approved use—not for all uses in the same disease—and applies this rule to past and future approvals. It also renews support for pediatric drug studies at the National Institutes of Health with $5 million each year for 2025–2027. Overall, it expands the FDA’s tools to protect children’s health and supports research programs that help kids with cancer and rare diseases.

Beyond medicines, the bill updates the organ transplant system by encouraging better data sharing (like using electronic health records and a public dashboard), allowing HHS to collect registration fees from network members to support operations, and requiring clear, quarterly reporting on how those fees are used, with an independent review after two years and a three‑year sunset on the fee authority. It also creates an Abraham Accords Office within the FDA, to be based in a country that signed the Abraham Accords, to share regulatory know‑how and help align medical product standards; a report to Congress is due three years after enactment on how the office is working .

• Who is affected
  • Children and families facing cancer or rare diseases; drug makers; FDA and NIH; organ procurement organizations and transplant centers; partners in Abraham Accords countries .
• What changes
  • Stronger, clearer pediatric study rules (including some combo studies) and enforcement with due‑diligence checks .
  • Priority review vouchers for rare pediatric diseases extended to 2029; study of their impact; voucher fee timing set .
  • Orphan‑drug exclusivity clarified to cover only the same approved use/indication.
  • NIH pediatric research funding for 2025–2027.
  • Transplant network tech upgrades, transparency, and temporary registration fees.
  • New FDA office to deepen cooperation with Abraham Accords countries.
• When
  • FDA enforcement of missed pediatric studies begins 180 days after enactment.
  • Some pediatric study requirements apply to applications submitted three years after enactment.
  • Rare pediatric disease vouchers run through September 30, 2029.
  • Transplant registration fee authority ends three years after enactment.
  • The new FDA Abraham Accords Office must be set up within two years; a report on its work is due at three years .