Overview
Title
To advance research to achieve medical breakthroughs in brain tumor treatment and improve awareness and adequacy of specialized cancer and brain tumor care.
ELI5 AI
The "BRAIN Act" is a bill that wants to find better ways to treat brain tumors and help more people know about special care for these tumors. It plans to do this by sharing research, creating teams to work on new treatments, and telling more people about how they can join in studies to learn more about brain health.
Summary AI
H.R. 9113, titled the "Bolstering Research And Innovation Now Act" or the "BRAIN Act," aims to enhance research for medical breakthroughs in treating brain tumors and to improve awareness and access to specialized care. The bill proposes developing a transparent system for reporting biospecimen collections from brain cancer research, establishing a Glioblastoma Therapeutics Network, and supporting CAR-T cell therapy for brain tumors. It also calls for a national public awareness campaign focusing on clinical trials and biomarker testing, pilot programs for monitoring brain tumor survivors, and FDA guidance to help brain tumor patients access clinical trials.
Published
Keywords AI
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Bill Statistics
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AnalysisAI
The Bolstering Research And Innovation Now Act or the BRAIN Act seeks to advance research and treatment in the area of brain tumors. The legislation, introduced in the House of Representatives, is aimed at promoting transparency in brain cancer research, supporting the development of new therapies, and improving public awareness and access to specialized healthcare. Key components include establishing a Glioblastoma Therapeutics Network, launching a national awareness campaign on clinical trials and biomarker testing, and creating pilot programs to care for brain tumor survivors.
General Summary of the Bill
The bill is structured to enhance the understanding and treatment of brain tumors, a condition affecting over a million people in the United States. It emphasizes collaboration among institutions, with significant appropriations dedicated to research and public awareness initiatives. The Act also stresses the importance of clinical trials and provides guidance to ensure that brain tumor patients have fair access to these trials. Another critical aspect is the establishment of a public database for biospecimen collections, ensuring that data is accessible and transparent.
Summary of Significant Issues
Several notable issues arise from the language and structure of the bill:
General Language and Lack of Specific Goals: The bill's stated purposes are broad, with few clearly defined metrics or outcomes. This generality makes it difficult to ascertain measurable achievements or evaluate the Act's effectiveness once implemented.
Funding and Budget Concerns: There are no detailed funding sources or budget allocations for certain initiatives, such as the searchable database for biospecimen collections, potentially leading to unexpected costs.
High Authorized Appropriations Without Clear Justification: The significant funds allocated for initiatives like the Glioblastoma Therapeutics Network are not justified with specific outcomes or success metrics, raising questions about financial prudence.
Lack of Clear Selection Criteria: The process for selecting grant recipients or collaborators is not well defined, which could lead to issues regarding fairness or transparency.
Privacy Concerns: The bill does not specify measures to protect patient privacy, particularly concerning biospecimen data, leading to potential ethical and legal issues.
Potential Impact on the Public and Stakeholders
Broadly speaking, if implemented effectively, the BRAIN Act could lead to significant advances in brain tumor research and treatment, benefiting patients and healthcare providers alike. Enhanced public awareness could foster greater participation in clinical trials, which are crucial for developing new treatments.
Positive Impacts:
- Patients and Families: Individuals affected by brain tumors might benefit from new therapies, improved survival rates, and better quality of life.
- Healthcare Providers and Researchers: The Act's focus on research funding could enable breakthroughs in treatment methodologies and support the professional development of medical practitioners and scientists.
Negative Impacts:
- Organizations and Entities: Without clear selection criteria, the allocation of funds may not be equitable or transparent, potentially leading to skepticism or dissatisfaction among stakeholders.
- Patient Privacy Advocates: The bill's lack of specific privacy measures might raise concerns about the ethical use and protection of sensitive patient data.
Overall, while the BRAIN Act aims to address significant challenges in brain tumor research and treatment, careful consideration of these issues is critical to ensure its successful implementation and to maximize its benefits to the public and key stakeholders.
Financial Assessment
The analysis of the financial aspects of H.R. 9113, also known as the "Bolstering Research And Innovation Now Act" or the "BRAIN Act," highlights several funding initiatives and issues related to the bill's proposed allocations. This commentary provides an overview of these financial references and aligns them with the identified issues.
Financial Allocations Summary
The BRAIN Act includes several specific funding authorizations aimed at addressing brain tumor treatment and awareness:
Glioblastoma Therapeutics Network: The bill authorizes $50,000,000 annually for five fiscal years (2026-2030) to support a Glioblastoma Therapeutics Network, which is intended to improve glioblastoma treatment through collaborative research and clinical trials.
Brain Tumor CAR–T Team Science Award: A separate allocation authorizes $10,000,000 annually for the same five-year period (2026-2030) to support research using CAR-T cell therapy for brain tumors.
Public Awareness Campaign: To enhance awareness of clinical trials and biomarker testing, the Act authorizes $10,000,000 for the period of fiscal years 2026 through 2030, specifically targeted at public engagement initiatives.
Pilot Programs for Brain Tumor Survivors: The Act provides for an allocation of $5,000,000 annually from 2026 to 2030, focused on developing and evaluating care models for brain tumor survivors.
Financial Allocations and Identified Issues
Several issues arise in relation to the financial allocations outlined in the BRAIN Act:
- Lack of Detailed Budget Allocations:
The public awareness campaign (Section 5) lacks a detailed breakdown of how the $10,000,000 will be specifically used. This could lead to potential mismanagement or inefficient distribution of resources, as the bill does not specify expenditures for each component of the campaign, such as the creation of materials, outreach efforts, and engagement strategies.
High Appropriation Amounts:
The appropriations of $50,000,000 annually for the Glioblastoma Therapeutics Network and $10,000,000 annually for CAR-T team research, both spanning five fiscal years, demand clear justification and expected outcomes to prevent concerns regarding fund utility. Without explicit projected outcomes or metrics to gauge success, these large funding amounts may be questioned for their necessity or efficacy.
Oversight and Accountability:
Across various sections, especially Sections 4, 5, and 6, there is a lack of clear oversight mechanisms to ensure that the allocated funds are utilized as intended. This absence might lead to resource misallocation or inefficiencies, affecting the programs' potential success and undermining the purpose of the financial investments.
Unspecified Funding for Infrastructure Projects:
- The act proposes establishing platforms, such as the searchable website for biospecimen collections (Section 3), without specifying funding for these infrastructure projects. This absence raises concerns of unforeseen costs and financial planning inadequacies, potentially impacting their development and implementation.
Overall, while the BRAIN Act promises significant financial investment towards advancing brain tumor research and care, these issues highlight the need for a more detailed allocation framework, clearer oversight protocols, and measurement guidelines to ensure that funds achieve intended objectives effectively and transparently.
Issues
The language in the 'purposes' section (Section 2) is quite general and may not clearly define measurable goals or outcomes, making it difficult to evaluate the effectiveness of the Act once implemented.
The bill does not provide details on funding sources or budget allocations for some key initiatives, such as the establishment and maintenance of a searchable website for biospecimen collections (Section 3), potentially leading to unforeseen costs.
The section on Clinical trials and biomarker testing national public awareness campaign (Section 5) lacks a clear breakdown of how the authorized appropriation of $10,000,000 will be allocated, which could lead to potential mismanagement or inefficient use of resources.
In Sections 4, "Glioblastoma Therapeutics Network; Brain tumor CAR–T team science award", high amounts of authorized appropriations ($50,000,000 annually for 5 years for the Glioblastoma Therapeutics Network and $10,000,000 annually for the Brain tumor CAR–T team) may raise questions without clear justification or projected outcomes.
There is a lack of specific metrics or outcomes defined to measure the success of various initiatives such as the national campaign or demonstration projects (Section 5) and the pilot programs for brain tumor survivors (Section 6), making it challenging to assess their success or justify the spending.
The power granted to the Director of NIH in Section 6 to make awards to eligible entities to establish pilot programs could lead to favoritism or lack of transparency if not strictly regulated.
The language regarding the competitive selection process for awarding funding in Sections 4 and 5 lacks specificity, which might lead to concerns about fairness and transparency in the selection process.
There is no mention in Section 404P (Section 3) or other sections on the protection of privacy for patients whose biospecimens may be used, leading to potential ethical and legal concerns.
The oversight mechanisms or accountability measures to ensure that funds are used as intended are not clearly defined across multiple sections, particularly in Sections 4, 5, and 6, which could open the door to inefficient or improper use of resources.
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; table of contents Read Opens in new tab
Summary AI
The BRAIN Act (Bolstering Research And Innovation Now Act) lays out its key components, including promoting transparency in brain cancer research, supporting glioblastoma treatment networks, raising awareness for clinical trials and biomarker tests, and initiating pilot programs for brain tumor survivor care. Additionally, the Act focuses on ensuring that patients with brain tumors have access to clinical trials through FDA guidance.
2. Findings; purposes Read Opens in new tab
Summary AI
Congress highlights that brain tumors affect over a million people in the U.S., with minimal improvements in treatment over decades. The purpose of the Act is to boost research and treatment development for brain tumors and enhance access to specialized healthcare.
3. Fostering transparency of biospecimen collections for brain cancer research Read Opens in new tab
Summary AI
The section establishes a requirement for individuals or entities, who collect or acquire brain tumor biospecimens funded by the National Institutes of Health (NIH), to report detailed information about these collections to the NIH. It also allows the creation of a public website to make this information accessible and enforces compliance by withholding funding from those who repeatedly or significantly violate the reporting requirements.
404P. Reporting of brain tumor biospecimen collections Read Opens in new tab
Summary AI
The section outlines requirements for reporting brain tumor biospecimen collections that are funded by the NIH. It mandates that existing collections be reported within 180 days and any new collections within 60 days, with the NIH Director responsible for establishing a public website for these collections and enforcing compliance through potential funding withdrawal for violations.
4. Glioblastoma Therapeutics Network; Brain tumor CAR–T team science award Read Opens in new tab
Summary AI
The text outlines amendments to the Public Health Service Act to establish two research initiatives: the Glioblastoma Therapeutics Network and the Brain Tumor CAR–T Team Science Award. These initiatives aim to support collaborative research and clinical trials for treating glioblastoma and brain tumors using advanced therapies, with authorized funding of $50 million and $10 million per year respectively from 2026 to 2030.
Money References
- “(b) Authorization of appropriations.—There is authorized to be appropriated $50,000,000 for each of fiscal years 2026 through 2030, to remain available until expended, to the Director of the Institute to carry out this section.
- “(b) Use of funds.—Funds received through an award under this section shall be used— “(1) to support collaborative multi-institutional research activities, including pre-clinical and investigational new drug studies; and “(2) for the purpose of supporting clinical trials to evaluate CAR–T therapeutic approaches to treating brain tumors. “(c) Authorization of appropriations.—There is authorized to be appropriated $10,000,000 for each of fiscal years 2026 through 2030, to remain available until expended, to the Director of the Institute to carry out this section.”
417H. Glioblastoma Therapeutics Network Read Opens in new tab
Summary AI
The Glioblastoma Therapeutics Network is a research program run by the Director of the Institute, focusing on improving glioblastoma treatments by supporting collaborative studies from early research to human clinical trials. The program is set to receive $50 million annually from 2026 to 2030 to facilitate these efforts.
Money References
- (b) Authorization of appropriations.—There is authorized to be appropriated $50,000,000 for each of fiscal years 2026 through 2030, to remain available until expended, to the Director of the Institute to carry out this section.
417I. Brain tumor CAR–T team science award Read Opens in new tab
Summary AI
The section describes a program where the Director of the Institute will provide competitive awards to support teams from multiple institutions using CAR-T cell therapy to treat brain tumors in adults and children. The funds are meant to facilitate research and clinical trials, with $10 million authorized annually from 2026 to 2030 for this purpose.
Money References
- (c) Authorization of appropriations.—There is authorized to be appropriated $10,000,000 for each of fiscal years 2026 through 2030, to remain available until expended, to the Director of the Institute to carry out this section.
5. Clinical trials and biomarker testing national public awareness campaign Read Opens in new tab
Summary AI
The section outlines a national public awareness campaign to educate people and health care providers about the significance of clinical trials and biomarker testing, particularly in cancer treatment. It mandates culturally sensitive outreach efforts for high-risk and underserved communities, involves collaboration with various stakeholders, and authorizes $10 million in funding for related programs from 2026 to 2030.
Money References
- “(c) Authorization of appropriations.—For the purpose of carrying out this section, there is authorized to be appropriated $10,000,000 for the period of fiscal years 2026 through 2030.”.
399V–8. Clinical trials and biomarker testing national public awareness campaign Read Opens in new tab
Summary AI
The section describes a national campaign organized by the Secretary to raise awareness about the importance of clinical trials and biomarker testing in cancer treatment. It includes activities like providing educational materials, public service announcements, and engaging with specific communities at higher risk of cancer, while also funding demonstration projects to improve education strategies for cancer and brain tumor patients with a budget of $10 million for fiscal years 2026 through 2030.
Money References
- (c) Authorization of appropriations.—For the purpose of carrying out this section, there is authorized to be appropriated $10,000,000 for the period of fiscal years 2026 through 2030. ---
6. Pilot programs to develop, study, or evaluate approaches to monitoring and caring for brain tumor survivors Read Opens in new tab
Summary AI
The proposed amendment to the Public Health Service Act allows the Director of NIH to fund pilot programs for developing, studying, or evaluating new ways to monitor and care for brain tumor survivors. It includes provisions for supporting diverse healthcare facilities across different regions, addressing follow-up care, multidisciplinary approaches, and providing information on appropriate care practices, with an appropriations authorization of $5 million annually from 2026 to 2030.
Money References
- “(3) USE OF FUNDS.—Funds from awards under this section may be used to develop, study, or evaluate one or more models for monitoring and caring for brain tumor survivors, which may include— “(A) evaluating follow-up care, educational accommodations, monitoring, and other survivorship programs (including peer support and mentoring programs); “(B) developing and evaluating models for providing multidisciplinary care; “(C) disseminating information to health care providers about culturally and linguistically appropriate follow-up care for brain tumor survivors and their families, as appropriate and practicable; “(D) developing and evaluating existing psychosocial evaluations, counseling, and support programs to improve the quality of life of brain tumor survivors and their families, which may include peer support and mentoring programs; “(E) designing and evaluating tools to support the secure electronic transfer of treatment information and care summaries from brain tumor care providers to other health care providers (including primary care providers), which information and care summaries shall include risk factors and a plan for recommended follow-up care; “(F) developing and evaluating initiatives that promote the coordination and effective transition of care between brain tumor care providers, primary care providers, mental health professionals, and other health care professionals, as appropriate, including models that use a team-based or multi-disciplinary approach to care; and “(G) disseminating information described in subparagraphs (A) through (F), including with respect to models, evaluations, programs, systems, and initiatives described in such subparagraphs, to other health care providers (including primary care providers) and to pediatric brain tumor survivors and their families, where appropriate and in accordance with Federal and State law. “(c) Authorization of appropriations.—There are authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2026 through 2030.”. ---
409K. Pilot programs to develop, study, or evaluate approaches to monitoring and caring for brain tumor survivors Read Opens in new tab
Summary AI
The section outlines a program, overseen by the NIH Director, to fund eligible entities for creating and studying methods to support brain tumor survivors. These methods include post-treatment care coordination, peer support programs, and initiatives for transferring medical information, with a budget of $5 million annually from 2026 to 2030.
Money References
- (3) USE OF FUNDS.—Funds from awards under this section may be used to develop, study, or evaluate one or more models for monitoring and caring for brain tumor survivors, which may include— (A) evaluating follow-up care, educational accommodations, monitoring, and other survivorship programs (including peer support and mentoring programs); (B) developing and evaluating models for providing multidisciplinary care; (C) disseminating information to health care providers about culturally and linguistically appropriate follow-up care for brain tumor survivors and their families, as appropriate and practicable; (D) developing and evaluating existing psychosocial evaluations, counseling, and support programs to improve the quality of life of brain tumor survivors and their families, which may include peer support and mentoring programs; (E) designing and evaluating tools to support the secure electronic transfer of treatment information and care summaries from brain tumor care providers to other health care providers (including primary care providers), which information and care summaries shall include risk factors and a plan for recommended follow-up care; (F) developing and evaluating initiatives that promote the coordination and effective transition of care between brain tumor care providers, primary care providers, mental health professionals, and other health care professionals, as appropriate, including models that use a team-based or multi-disciplinary approach to care; and (G) disseminating information described in subparagraphs (A) through (F), including with respect to models, evaluations, programs, systems, and initiatives described in such subparagraphs, to other health care providers (including primary care providers) and to pediatric brain tumor survivors and their families, where appropriate and in accordance with Federal and State law. (c) Authorization of appropriations.—There are authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2026 through 2030. ---
7. FDA guidance to ensure brain tumor patient access to clinical trials Read Opens in new tab
Summary AI
The section requires the Secretary of Health and Human Services to create guidelines within one year to prevent brain tumor patients and those with rare cancers from being unfairly excluded from clinical trials for other treatments.