S.705 - Innovation in Pediatric Drugs Act of 2025 (119th Congress)
Summary
S.705, the Innovation in Pediatric Drugs Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act to improve pediatric cancer investigations and the study of drugs in children. The bill focuses on ensuring accountability for pediatric study requirements, enhancing FDA reporting on Pediatric Research Equity Act (PREA) enforcement, and modifying funding for pediatric research programs. It also addresses the application of pediatric research requirements to orphan drugs and introduces guidance and studies related to this.
Expected Effects
This act will likely lead to more comprehensive pediatric studies of drugs, especially for cancer and rare diseases. It will also increase transparency and accountability in the enforcement of pediatric study requirements. The changes aim to improve the availability of information on drug safety and efficacy for children, potentially leading to better treatment options.
Potential Benefits
- Improved Pediatric Cancer Treatment: Encourages innovation in molecularly targeted pediatric cancer drugs.
- Increased Accountability: Holds drug companies accountable for completing pediatric studies.
- Enhanced Transparency: Requires the FDA to report on penalties for non-compliance with pediatric study requirements.
- Better Orphan Drug Studies: Improves the applicability of pediatric research requirements to orphan drugs, ensuring studies are conducted when meaningful therapeutic benefits are possible.
- More Informed Treatment Decisions: Provides more information on the safety and efficacy of drugs for children.
Most Benefited Areas:
Potential Disadvantages
- Increased Costs for Drug Development: The requirement for pediatric studies, even for orphan drugs, may increase the cost and complexity of drug development, potentially discouraging investment in certain areas.
- Delays in Drug Availability: The additional studies and regulatory hurdles could delay the availability of new drugs, including those for rare diseases.
- Potential for Unnecessary Studies: Requiring pediatric studies for orphan drugs even when the benefit is uncertain could expose children to unnecessary risks.
- Administrative Burden: The FDA will face an increased administrative burden in managing the new requirements and guidance.
- Uncertain Impact on Rare Disease Drug Development: The GAO study is needed to assess the actual impact on rare disease drug development, highlighting the uncertainty of the bill's effects.
Constitutional Alignment
The bill aligns with the Constitution's general welfare clause (Preamble) by promoting the health and well-being of children through improved drug studies and access to information. It also falls under Congress's power to regulate interstate commerce (Article I, Section 8) as it pertains to the regulation of drugs and pharmaceuticals. The bill does not appear to infringe on any specific individual rights or freedoms guaranteed by 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).