One Pagers

Mikaela Naylon Give Kids a Chance Act, HR 1262

The Mikaela Naylon Give Kids a Chance Act was introduced in the House by Representatives Michael McCaul (R-TX), Debbie Dingell (D-MI) and Gus Bilirakis (R-FL).

Last year, on December 2024, the Give Kids a Chance Act was about to be passed by Congress as part of healthcare package attached to an end-of-year funding bill. Three hours before the vote, Elon Musk tweeted that for every Republican who voted for the end-of-year package with the health package attached, he would fund someone to run against them in a primary. The bill fell apart. The health package was cut. The Give Kids a Chance Act did not pass.

This year, on December 1, 2025, the House renamed the Give Kids a Chance Act after Mikaela Naylon.

The House then passed the Act unanimously with 313 cosponsors.

Give Kids a Chance Act, S 3302 

The Mikaela Naylon Give Kids a Chance Act was re-introduced in the Senate by Senator Markwayne Mullin (R-OK) and Senator Michael Bennet (D-CO) and renamed after Mikaela Naylon. It has the exact same language as HR 1262, which was passed by the House..

On December 19, 2025, the Senate debated the Act. Senator Cassidy (R-LA), Chair of the Senate Health, Education, Labor and Pensions Committee, committed to Senator Sander’s community health centers priority, which constituted $500 million in funding for FY 2026.

Senator Sanders asked that the community health centers bill as well as three other of his priorities totalling another $500 million for FY2026, be voted on as part of the Act. Senator Maggie Hassan (D-NH) asked Senator Sanders to vote “aye” on the unamended Act, noting that there was no path to passage of Senator Sander’s priorities in the House and that if attached to the Mikaela Naylon Give Kids a Chance Act, Senator Sander’s priorities would sink the entire bill.

A unanimous consent vote was taken on the Mikaela Naylon Give Kids a Chance Act. Senator Bernie Sanders blocked it.

A unanimous consent vote was taken on the Mikaela Naylon Give Kids a Chance Act with Senator Sanders’ priorities. Senator Markwayne Mullin blocked it.

Review of the Mikaela Naylon Give Kids a Chance Act

Sec 2 of Give Kids a Chance Act, HR 1262, Give Kids a Chance Act Combination Therapies: Provides the FDA with authority to direct pediatric cancer trials for combination drugs when the drugs are owned by the same company or are generics.  Combinations have been demonstrated to be the best chance of new cures for kids with cancer.   This provision is from the Give Kids a Chance Act, HR 3433 of the 118th Congress.

Sec 5 of HR 1262, Reauthorization of Rare Pediatric Priority Review Voucher Program through FY 2029 to incentivize the development of drugs for rare pediatric diseases.  This program has expired despite bringing 60 new drugs for kids to market.  This provision is from the Creating Hope Reauthorization Act, HR 7384, of the 118th Congress.

Sec 3 of HR 1262, Innovation in Pediatric Drugs Act: Provides the FDA the same authority to enforce against companies that do not complete their pediatric study requirements as the FDA has to enforce against companies that do not complete other post market study requirements.  This provision is from part of the Innovation in Pediatric Drugs Act, HR 6664, of the 118th Congress.

Sec 6 of HR 1262, RARE Act: Clarification that Orphan Drug Exclusivity applies to the approved indication rather than the potentially broader designation.  This provision is from the RARE Act, HR 7382, of the 118th Congress.

Sec 7 of HR 1262, Pediatric drug studies: requires that $25,000 in a designated NIH fund be used to study pediatric drugs.

Sec 8 of HR 1262, Organ Procurement:  Provides for the collection of fees from members of the Organ Procurement and Transplantation Network (OPTN) to support the operation.   This provision is from the Securing the U.S. Organ Procurement and Transplantation Network Act, HR 2544, of the 118th Congress.

Sec 9 of HR 1262, FDA Office: The FDA shall establish an office in an Abraham Accord country.  This provision is from the United States-Abraham Accords Cooperation and Security Act of 2024, HR 7155, of the 118th Congress.

Sec 10 of HR 1262 , Generic Drugs: Requires the FDA to inform generic applicants of differences in ingredients between their product and the brand-name reference drug

Sec 11 of HR 1262, Extends Medicare Improvement Fund through FY26: This Fund adjusts the amounts that Medicare pays to health care providers and suppliers.