Mikaela Naylon Give Kids a Chance Act of 2025
Summary
The Mikaela Naylon Give Kids a Chance Act of 2025 aims to amend the Federal Food, Drug, and Cosmetic Act to enhance research into molecularly targeted pediatric cancer investigations. It focuses on streamlining the drug approval process for pediatric cancer treatments and extending the priority review voucher program. The Act also mandates reports and studies to assess the effectiveness of these measures.
Expected Effects
This act will likely accelerate the development and availability of new cancer drugs for children by incentivizing pharmaceutical companies to invest in pediatric cancer research. It also extends the priority review voucher program, providing further incentives for rare pediatric disease treatments. The required reports and studies will provide oversight and accountability for the act's implementation and effectiveness.
Potential Benefits
- Faster development of molecularly targeted cancer drugs for children.
- Increased incentives for pharmaceutical companies to research rare pediatric diseases.
- Streamlined drug approval processes for pediatric cancer treatments.
- Improved data collection and analysis regarding the effectiveness of pediatric cancer drug development.
- Potential for new treatments and improved outcomes for children with cancer.
Potential Disadvantages
- Potential for increased drug costs due to the priority review voucher system.
- Possible shift in research focus towards more profitable rare pediatric diseases, potentially neglecting other areas.
- The act's applicability is delayed by three years, which could slow down immediate progress.
- Increased workload for the FDA due to the priority review voucher program.
- Potential for unintended consequences related to the use of inactive ingredients in drug combinations.
Constitutional Alignment
The act aligns with the Constitution's general welfare clause (Preamble) by promoting public health through incentivizing the development of treatments for pediatric cancer. Congress's power to regulate interstate commerce (Article I, Section 8) provides the basis for amending the Federal Food, Drug, and Cosmetic Act. The Act does not appear to infringe upon any specific constitutional rights or limitations.
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).