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House Version of Give Kids a Chance Act, HR 1262

Give Kids a Chance Act, HR 1262

 The Give Kids a Chance Act seeks to accelerate the development of novel treatments for children with cancer and rare diseases.   It was introduced in the House by Reps. McCaul, Dingell and Bilirakis.

• The 118th House passed the Give Kids a Chance Act passed unanimously as a stand-alone bill

• Give Kids a Chance Act has over 310 bipartisan cosponsors

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.

New Amendments in the AINS:

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. 

For more information, please contact:

(McCaul) Teddy.Dubuque@mail.house.gov                              
(Dingell) William.Seabrook@mail.house.gov                         (Bilirakis)LeighAnn.Fairly@mail.house.gov