Give Kids a Chance Act of 2025
Summary
The "Give Kids a Chance Act of 2025" aims to amend the Federal Food, Drug, and Cosmetic Act, focusing on molecularly targeted pediatric cancer investigations. It seeks to enhance research into pediatric uses of drugs and ensure the completion of pediatric study requirements. The act also addresses orphan drug exclusivity, extends priority review vouchers for rare pediatric diseases, and includes provisions related to organ transplantation and generic drug applications.
Expected Effects
The act is likely to accelerate the development and approval of drugs for pediatric cancer by providing additional incentives and clarifying regulatory pathways. It may also increase transparency in generic drug applications and improve the organ transplantation network. The establishment of an Abraham Accords Office within the FDA aims to foster international cooperation.
Potential Benefits
- Expedited development of pediatric cancer drugs through molecularly targeted investigations.
- Extension of priority review vouchers to encourage treatments for rare pediatric diseases.
- Increased transparency in generic drug applications, potentially leading to more affordable medications.
- Improvements to the Organ Procurement and Transplantation Network, potentially increasing the number of successful transplants.
- Enhanced international cooperation through the establishment of the Abraham Accords Office.
Potential Disadvantages
- Potential for increased costs associated with drug development, which could be passed on to consumers.
- Limitations on exclusive approval of orphan drugs might reduce incentives for companies to invest in treatments for rare diseases.
- The act's reliance on industry coordination may not always align with public health priorities.
- The establishment of the Abraham Accords Office could be viewed as politically motivated, potentially affecting its effectiveness.
- Some provisions, such as registration fees for organ transplantation, could create additional financial burdens.
Constitutional Alignment
The act primarily aligns with Congress's power to regulate interstate commerce (Article I, Section 8) through amendments to the Federal Food, Drug, and Cosmetic Act. The focus on public health and welfare also resonates with the Constitution's broad goals of promoting the general welfare of the population, as stated in the Preamble. The Act does not appear to infringe upon any specific individual rights or liberties outlined in the Bill of Rights.
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).