Overview
Title
To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes.
ELI5 AI
S. 932, named the "Give Kids a Chance Act of 2025," is a new rule that asks people who make medicine to look into special kinds of treatments for kids with cancer. It also lets the government keep giving out special rewards to companies that make rare disease medicines for kids for a few more years.
Summary AI
S. 932, also known as the "Give Kids a Chance Act of 2025," proposes amendments to the Federal Food, Drug, and Cosmetic Act. The bill aims to improve research into pediatric cancer by requiring drug makers to conduct investigations into drugs targeted for children's cancer treatments. It also seeks to extend the authority of the Food and Drug Administration (FDA) to issue priority review vouchers for rare pediatric diseases to September 2029, and calls for reviews and reports on the effectiveness of these measures in encouraging the development of pediatric cancer treatments.
Published
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AnalysisAI
General Summary of the Bill
The proposed legislation titled the "Give Kids a Chance Act of 2025," seeks to amend the Federal Food, Drug, and Cosmetic Act. The core purpose of the bill is to enhance the investigation of drugs used for pediatric cancer treatment, with a particular emphasis on those that are molecularly targeted. In addition, the bill extends the authority for priority review vouchers for rare pediatric diseases, which incentivize the development of drugs by providing expedited review processes.
Summary of Significant Issues
Complex Language and Rapid Implementation Timelines: Section 2 of the bill contains intricate legal and medical language that might be difficult for the general public to grasp. Moreover, the schedule for implementing these changes, including issuing guidance within a year, may lead to rushed processes and insufficient public feedback.
Unclear Criteria for Application: The bill lacks explicit guidelines on how to determine the applicability of certain subsections. This absence might create inconsistencies in how the law is applied, potentially leading to legal and operational challenges.
Priority Review Voucher Extension: Extending the authority for priority review vouchers until 2029 raises questions about their long-term efficacy and necessity, as there is no current evidence supporting the need for such an extension.
Equity Concerns for Companies: The bill does not sufficiently address how different sizes of companies—large or small—might be affected by the allocation of these priority review vouchers, potentially leading to unequal competitive advantages.
Delayed Accountability and Feedback: The timelines for the reports required by the bill, extending from six to ten years, may delay assessments of the amendments' effectiveness, thus delaying any necessary policy adjustments.
Impact on the Public
This bill aims to improve pediatric cancer treatments by encouraging more comprehensive research and development in this area. If successful, these efforts could lead to significant advancements in medical treatments available to children with cancer. However, the rapid timelines and complex language involved could impact public understanding and trust in the legislative process.
Impact on Specific Stakeholders
Pharmaceutical Companies: The changes proposed could intensify regulatory requirements for companies developing drugs for pediatric cancer, potentially increasing research investments and operational complexities. The extension of the priority review vouchers could benefit these entities by providing faster time-to-market for novel treatments, but it might also favor larger companies with more resources.
Regulatory Bodies: The FDA will bear increased responsibilities, from issuing guidance to implementing new regulations and reporting to Congress. This increased workload might strain resources and impact other regulatory activities.
Children with Cancer and Their Families: The potential development of more effective pediatric cancer treatments could give families hope for better clinical outcomes. However, if the bill's provisions lead to delays or prioritize profit over public health, the intended benefits might not reach those in need timely.
Small and Medium Enterprises (SMEs): These companies could face challenges in competing with larger firms for priority review vouchers and in meeting new, potentially costly research requirements.
In conclusion, while the bill has the potential to improve pediatric cancer treatments, the outlined issues suggest a need for greater clarity, realistic timelines for implementation, and careful consideration of the equitable distribution of benefits among stakeholders.
Issues
The rapid timeline for the Secretary to issue draft guidance and finalize it within a year of the comment period might lead to inadequate public input or rushed implementation. This is found in Section 2(b) and could impact the development process and stakeholder engagement.
The lack of clear criteria or guidelines in determining whether subparagraph (A) or (B) of Section 505B(a)(1) applies could result in inconsistent application by the Secretary, creating legal ambiguities and potential inequities. This is highlighted in Section 2(a)(2) and 2(a)(3).
The bill extends the priority review voucher authority for rare pediatric diseases from December 20, 2024, to September 30, 2029, without clear evidence of its continued necessity or effectiveness, potentially prolonging governmental obligations. This is covered in Section 3(a) and could spark political and financial debates around its value.
There is a concern that the bill does not address potential inequities for large versus small companies in receiving, transferring, or utilizing the priority review vouchers, which could influence the competitive landscape in drug development. This issue relates to Section 3 and might have legal and ethical implications.
The section regarding molecularly targeted pediatric cancer investigations contains complex language, making it difficult for the general public to comprehend. This could lead to misunderstandings or misinterpretations of its legal and practical implications, as mentioned in Section 2(a).
The GAO study lacks specified criteria to evaluate the success of priority review vouchers for rare pediatric diseases, which could result in inconclusive findings. This issue is covered in Section 3(c), affecting the ability to measure the policy's impact effectively.
The timeline for implementation and subsequent reports (6 to 10 years) delays accountability and feedback on the efficacy of the amendments, which may impede timely policy adjustments. This concern is noted in Section 2(d).
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Short title Read Opens in new tab
Summary AI
The first section of the Act states that it will be officially named the “Give Kids a Chance Act of 2025.”
2. Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs Read Opens in new tab
Summary AI
The bill outlines new requirements for the Food and Drug Administration (FDA) to investigate drugs for use in treating pediatric cancers, focusing on those that are molecularly targeted. It allows for the submission of drug applications and requires the FDA to issue guidance, submit reports to Congress, and coordinate with industry to implement these changes, aiming to improve drug development for treating childhood cancers.
3. Extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases Read Opens in new tab
Summary AI
The section extends the authority to issue priority review vouchers for rare pediatric diseases from December 2024 to September 2029 and outlines the conditions for user fees related to using these vouchers. It also mandates a study by the Government Accountability Office (GAO) to assess the impact and effectiveness of these vouchers in promoting the development of treatments for rare pediatric diseases.