HR 1262 · Passed House · 12-02-25
Mikaela Naylon Give Kids a Chance Act
What does the Mikaela Naylon Give Kids a Chance Act do?
HR 1262 is a House bill sponsored by Rep. Michael T. McCaul (R-TX). Requires drug companies to study whether their targeted adult cancer drugs work in children — including when used in combination with other cancer drugs — and lets FDA seek penalties from companies that skip required pediatric studies without a good-faith effort. It also extends the rare pediatric disease priority review voucher program through September 30, 2029, modernizes the organ transplant network, and raises the Medicare Improvement Fund from $1.40B to $2.62B.
Did HR 1262 pass? Where it stands
As of July 17, 2026, HR 1262 has passed the House.
Status: Passed House
Latest vote: House Passed by voice vote on December 1, 2025
Outlook: Likely
Key provisions
- Pediatric Cancer Drug Studies
- Required studies now reach combination cancer therapies
- Applies to drug applications filed 3 years after enactment
- Penalties possible for sponsors lacking due diligence on studies
- Rare Disease Incentives
- Priority review voucher awards extended through September 30, 2029
- Vouchers grant 6-month FDA review and can be sold
- Orphan-drug exclusivity narrowed to the approved use or indication
- Transplant Network and Medicare Fund
- Transplant-network registration fees authorized for 3 years
- Electronic health-record integration for organ donor referrals
- Medicare Improvement Fund raised from $1.40B to $2.62B
Last updated July 10, 2026