H.R.1262 - Give Kids a Chance Act of 2025 (119th Congress)
Summary
H.R.1262, the Give Kids a Chance Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act to improve research and development of treatments for pediatric cancer. The bill focuses on molecularly targeted pediatric cancer investigations, ensuring the completion of pediatric study requirements, and extending the authority to issue priority review vouchers for rare pediatric diseases. It also addresses limitations on exclusive approval or licensure of orphan drugs and establishes a program for pediatric studies of drugs.
Expected Effects
The likely effect of this bill is to incentivize pharmaceutical companies to invest in pediatric cancer research and drug development. This is achieved through a combination of regulatory changes, financial incentives (priority review vouchers), and increased oversight. The bill also seeks to improve the organ transplantation network and establish an Abraham Accords Office within the FDA to foster international cooperation.
Potential Benefits
- Accelerated Development of Pediatric Cancer Treatments: The bill streamlines the process for molecularly targeted pediatric cancer investigations.
- Increased Accountability for Pediatric Studies: It ensures the completion of required pediatric studies.
- Incentivizes Research for Rare Pediatric Diseases: The extension of priority review vouchers encourages the development of treatments for rare pediatric diseases.
- Improved Organ Transplantation Network: Amendments to the Public Health Service Act aim to enhance the efficiency and transparency of the organ procurement and transplantation network.
- International Collaboration: The establishment of an Abraham Accords Office within the FDA promotes collaboration with Abraham Accords countries on regulatory oversight.
Potential Disadvantages
- Potential for Increased Drug Costs: The priority review voucher program could lead to higher drug prices as companies seek to recoup their investment.
- Administrative Burden: The establishment of new offices and reporting requirements may increase the administrative burden on the FDA.
- Limited Scope: The bill primarily focuses on pediatric cancer and may not address other critical areas of pediatric health.
- Uncertainty in Long-Term Effectiveness: The GAO reports are required to assess the effectiveness of some provisions, indicating uncertainty about their long-term impact.
- Possible unintended consequences related to orphan drug exclusivity: The limitations on orphan drug exclusivity could disincentivize some research, although the intent is to promote more competition.
Constitutional Alignment
The bill primarily amends existing legislation related to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Its focus on regulating pharmaceuticals and healthcare falls under the Commerce Clause (Article I, Section 8), which grants Congress the power to regulate interstate commerce. The establishment of offices and reporting requirements is within the scope of Congress's legislative authority. The bill does not appear to infringe upon any specific constitutional rights or freedoms.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).