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 plan to find better ways to treat brain tumors and make sure people know how to get help, like using more money to study new treatments and telling everyone about cancer research programs.
Summary AI
The BRAIN Act aims to enhance research and treatment for brain tumors by increasing transparency of biospecimen collections and establishing programs like the Glioblastoma Therapeutics Network for testing new treatments. It proposes a national awareness campaign to educate about cancer clinical trials and biomarker testing, while also setting up pilot programs to improve care for brain tumor survivors. Additionally, it directs the FDA to issue guidance to ensure brain tumor patients have access to clinical trials.
Published
Keywords AI
Sources
Bill Statistics
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Language
Complexity
AnalysisAI
General Summary of the Bill
The BRAIN Act, or "Bolstering Research And Innovation Now Act," aims to enhance efforts in brain tumor treatment and raise awareness about cancer care in general. The legislation outlines various initiatives, such as promoting transparency in biospecimen collections, creating the Glioblastoma Therapeutics Network, and launching a public awareness campaign on cancer clinical trials. Additionally, it seeks to set up pilot programs for monitoring brain tumor survivors and to issue guidance to ensure brain tumor patients can access clinical trials.
Significant Issues
One significant issue with the bill is the authorization of extensive funding without a detailed breakdown. Sections 4 and 417H, for example, allocate $50 million annually for the Glioblastoma Therapeutics Network but lack transparency in how these funds will be used efficiently. This absence of financial specifics raises concerns about potential wastefulness and accountability in fund allocation.
Moreover, provisions for creating a searchable website, as laid out in Sections 3 and 404P, do not specify funding mechanisms or budgets, thereby leaving room for potentially unmonitored and inefficient spending. This lack of clarity extends to Sections 5 and 399V–8 as well, which allocates $10 million for a public awareness campaign without laying out criteria or metrics for measuring success.
Vague language and undefined terms also hinder the bill's implementation. Terms like "covered biospecimen collection" and "cooperative agreements, or other awards" are not clearly defined, leading to potential ambiguity and subjective interpretation.
Broad Public Impact
If enacted, the bill could reshape how brain tumors and rarer cancers are researched and treated, possibly leading to medical breakthroughs and heightened awareness. Public campaigns and collaborative research efforts might make treatments more accessible and effective, potentially improving survival rates over time.
However, the potential for inefficient spending due to unspecified fund allocation could mean that resources might not be utilized in the most effective way. The public could see nominal changes unless rigorous oversight mechanisms are put in place to ensure the efficient use of taxpayer dollars.
Specific Stakeholder Impact
On a positive note, the bill might positively impact healthcare providers and institutions focusing on cancer treatment and research by providing substantial funding and resources. The collaboration opportunities within this bill could facilitate advancements in treatment strategies and encourage innovation.
Patients with brain tumors and their families could see tangible benefits if the research leads to more effective therapies and if awareness campaigns help raise participation in clinical trials, potentially improving their quality of life.
Conversely, smaller entities required to report biospecimen collections may face administrative burdens. The vague language in the bill might also create inconsistencies in implementation, potentially disadvantaging some stakeholders. Additionally, if the funding is not scrutinized or used effectively, stakeholders might not see the intended improvements, leading to public frustration and skepticism about government-led health initiatives.
In summary, while the BRAIN Act has the potential to advance medical research and improve care for brain tumor patients, the issues around funding transparency and procedural ambiguities could affect its broader impact and efficacy.
Financial Assessment
The BRAIN Act, proposed to advance research and treatment for brain tumors, includes several financial allocations aimed at enhancing research and increasing public awareness. These financial references are integral to the implementation of the bill's objectives, but they also raise certain concerns.
Financial Allocations
The bill makes several significant financial commitments:
Glioblastoma Therapeutics Network: It authorizes an annual appropriation of $50,000,000 from fiscal years 2026 through 2030. This funding is aimed at improving the treatment of glioblastoma by supporting collaborative research through cooperative agreements or other awards.
Brain Tumor Cellular Immunotherapy (including CAR–T) Team Science Award: The bill allocates $10,000,000 annually, also for fiscal years 2026 through 2030. This funding is intended to support multi-institutional research and clinical trials related to cellular immunotherapy for brain tumors.
Cancer Clinical Trials and Biomarker Testing Public Awareness Campaign: An amount of $10,000,000 is authorized for the period of fiscal years 2026 through 2030 to conduct a national campaign increasing awareness of cancer clinical trials and biomarker testing.
Pilot Programs for Brain Tumor Survivors: Another $5,000,000 is allocated annually for pilot programs focused on developing, studying, or evaluating approaches to monitor and care for brain tumor survivors.
Issues and Concerns
The financial allocations, while substantial and potentially impactful, bring forth several concerns:
The $50,000,000 annual allocation for the Glioblastoma Therapeutics Network lacks detailed breakdowns or justifications, as pointed out in the issues section. This absence of detailed financial planning could lead to potential wasteful spending and lack of accountability in fund allocation.
Both the creation of a biospecimen collection website and the financial commitment of $10,000,000 for a public awareness campaign are not accompanied by specific funding mechanisms or criteria for measuring the success of these initiatives. This raises the risk of inefficient use of resources and funds.
Regarding the pilot programs for caring for brain tumor survivors with an annual funding of $5,000,000, there is a lack of specific guidance on how artificial intelligence and machine learning tools will be used. Without clear parameters, these investments could become unnecessary or overly ambitious.
Another concern relates to the vague language used for financial mechanisms, such as "cooperative agreements, or other awards," which may contribute to uncertainty in the applicability and implementation of these rules. Similarly, the undefined nature of terms such as "repeated or egregious violations" could hinder consistent enforcement of oversight mechanisms.
In conclusion, while the financial allocations in the BRAIN Act are substantial and suggest a strong commitment to advancing brain tumor research and care, the undefined expenditures and vague criteria present potential risks for accountability and efficient use of funds. Addressing these concerns could strengthen the bill's implementation and ensure that the allocated resources effectively achieve their intended outcomes.
Issues
The provisions in Sections 4 and 417H authorize significant funding ($50,000,000 annually from 2026 to 2030) for the Glioblastoma Therapeutics Network, but lack detailed breakdowns or justifications for these expenses, raising concerns about potential wasteful spending and lack of accountability in fund allocation.
Sections 3 and 404P mandate the establishment of a searchable website for brain tumor biospecimen collections but fail to specify the funding mechanism or budget involved, leading potentially to unmonitored spending and operational inefficiencies.
Sections 5 and 399V–8 authorize $10,000,000 for a public awareness campaign regarding cancer clinical trials, with vague language regarding criteria and metrics for measuring success, posing a risk of inefficient use of funds and resources.
The lack of specific guidance in Sections 6 and 409K regarding the use of artificial intelligence and machine learning tools in pilot programs could lead to potentially wasteful technological investments without clear necessity or scope.
Sections 404P and 417H use vague language such as 'covered biospecimen collection' and 'cooperative agreements, or other awards,' which may lead to uncertainty and ambiguity in the applicability and implementation of these funding mechanisms.
Section 7 lacks clarity on budget allocation details and does not specify criteria or methods for guidance development, potentially leading to unclear or ineffective policy outcomes.
Sections 3 and 404P do not define 'repeated or egregious violations,' leading to potential inconsistencies and ambiguities in enforcement of the oversight mechanism.
Sections 4 and 417I allocate $10,000,000 annually for research on brain tumor-related cellular immunotherapy but do not specify criteria or metrics for evaluating research effectiveness, posing accountability challenges.
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 first section of the BRAIN Act provides the short title of the legislation, which is “Bolstering Research And Innovation Now Act” or “BRAIN Act”, and outlines the table of contents that highlights the key areas the Act will address. These areas include transparency in brain cancer research, support for glioblastoma therapies, awareness campaigns for cancer trials, and access for brain tumor patients to clinical trials.
2. Findings; purposes Read Opens in new tab
Summary AI
Congress acknowledges the challenges posed by brain tumors, noting the lack of significant progress in survival rates and treatment options over the years. This Act aims to promote research and improve access to care for individuals with brain tumors and other rare cancers in the United States.
3. Fostering transparency of biospecimen collections for brain cancer research Read Opens in new tab
Summary AI
The section amends the Public Health Service Act to improve transparency regarding brain cancer research by creating a publicly accessible website containing information on biospecimen collections funded by the NIH. It requires individuals or entities to report information about existing and new biospecimen collections and allows the NIH to withhold funding from those who do not comply with these requirements.
404P. Reporting of brain tumor biospecimen collections Read Opens in new tab
Summary AI
In this section, the regulations specify that any biospecimens related to brain tumors, collected with NIH funding, must be reported to the NIH within specific timeframes for tracking and public access. Additionally, the NIH will oversee compliance and may withhold funding for repeated non-compliance.
4. Glioblastoma Therapeutics Network; brain tumor related cellular immunotherapy (including CAR–T) team science award Read Opens in new tab
Summary AI
The bill proposes the establishment of the Glioblastoma Therapeutics Network to improve glioblastoma treatments through collaborative research and early clinical trials, with $50 million authorized annually from 2026 to 2030. It also introduces funding for developing cellular immunotherapy for brain tumors, like CAR–T, with $10 million authorized annually for the same years.
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 brain tumor related cancer cellular immunotherapy, including CAR–T. “(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.”. (b) Transition for the Glioblastoma Therapeutics
417H. Glioblastoma Therapeutics Network Read Opens in new tab
Summary AI
The section establishes the "Glioblastoma Therapeutics Network," a research program led by the Director of the Institute aimed at improving treatments for glioblastoma. It authorizes $50 million per year from 2026 to 2030 for this purpose, using cooperative agreements and other awards through the National Institutes of Health to support collaborations between institutions from the early stages of drug development through early clinical trials.
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 related cellular immunotherapy (including CAR–T) team science award Read Opens in new tab
Summary AI
The bill section outlines a plan to fund research on brain tumor treatments using cellular immunotherapy, like CAR-T. It allows the National Institutes of Health to allocate $10 million annually from 2026 to 2030 to support research and clinical trials across multiple institutions.
Money References
- (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 brain tumor related cancer cellular immunotherapy, including CAR–T. (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. Cancer clinical trials and biomarker testing national public awareness campaign Read Opens in new tab
Summary AI
The bill section establishes a national public awareness campaign on cancer clinical trials and biomarker testing, urging the Secretary to increase awareness among health care providers and the public, including specific populations at higher risk of cancer. It also introduces demonstration projects for outreach and education strategies, with an allocated budget of $10 million 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. Cancer clinical trials and biomarker testing national public awareness campaign Read Opens in new tab
Summary AI
The text outlines a national campaign led by the Secretary to raise awareness among healthcare providers and the public about the importance of cancer clinical trials and biomarker testing. It includes distributing materials, public service announcements, and consulting with various organizations. Additionally, it describes a program to fund demonstration projects that explore outreach strategies for cancer and brain tumor education, with an appropriation of $10 million authorized for these efforts 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.
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 bill section allows the NIH Director to provide funding to qualified organizations like medical schools and hospitals to create pilot programs for helping those who have survived brain tumors. These programs will explore ways to monitor survivors' health, plan follow-up care, share medical information securely, and provide support to improve their quality of life.
Money References
- “(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 allows the Director of the NIH to fund pilot programs aimed at developing, studying, or evaluating methods for monitoring and caring for brain tumor survivors, covering both adults and children. Eligible entities like medical schools, hospitals, and cancer centers can use these funds for a range of activities, such as follow-up care, educational support, psychosocial programs, and the improvement of care coordination, with a budget of $5,000,000 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, which may include tools generated by artificial intelligence and machine learning, to support the secure electronic transfer of treatment information and care summaries from brain tumor care providers to other health care providers (including primary and specialty 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 and specialty 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 and specialty 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 Secretary of Health and Human Services, through the FDA Commissioner, must provide guidance within a year to find ways to reduce the exclusion of brain tumor and rare cancer patients from clinical trials targeting other conditions.