BRAIN Act
- Sponsor
- Rep. Fitzpatrick, Brian K. [R-PA-1]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Apr 9, 2025
Bottom line
The BRAIN Act aims to accelerate brain tumor research and improve patient outcomes by increasing funding for specific research initiatives, enhancing public awareness of clinical trials, and supporting comprehensive survivor care.
What it actually does
The Bolstering Research And Innovation Now (BRAIN) Act establishes new research programs at the National Institutes of Health (NIH) for glioblastoma and brain tumor cellular immunotherapy, authorizing significant funding. It mandates a national public awareness campaign for cancer clinical trials and biomarker testing, including targeted outreach to underserved populations. Additionally, the bill creates pilot programs for comprehensive brain tumor survivor care and directs the Food and Drug Administration (FDA) to issue guidance to minimize the exclusion of brain tumor patients from clinical trials.
Proponents argue
Proponents argue that the bill addresses the urgent need for more effective brain tumor treatments and better patient support, citing stagnant survival rates and the devastating impact of these diseases, especially on children. They emphasize that increased research funding, improved clinical trial access, and enhanced survivor care are crucial steps toward finding cures and significantly improving the quality of life for patients.
Opponents contend
No specific organized opposition to this bill is evident in the provided text or public discourse. Potential general opposition might focus on the overall cost of new federal programs or concerns about expanding federal involvement in healthcare research without clear metrics for success, or prioritization over other diseases.
The bill is concise and clearly structured, allowing an informed reader to understand its provisions within a reasonable timeframe.
Sec. 3, adding Sec. 404P to Part A of title IV of the Public Health Service Act
Fostering Transparency of Biospecimen Collections for Brain Cancer Research
This provision authorizes the NIH Director to establish a searchable website for information on brain tumor biospecimen collections funded by NIH. It mandates that individuals or entities maintaining such collections report their existence, location, and description to the NIH, and includes an oversight mechanism allowing NIH to withhold funding for repeated violations.
Supporters argue
Proponents argue this provision will enhance research efficiency by making valuable biospecimen collections more discoverable and accessible to the broader scientific community, preventing duplication of effort and accelerating breakthroughs in brain tumor treatment.
Critics contend
No specific opposition is typically raised against transparency measures for publicly funded research resources, though some institutions might express concerns about the administrative burden of new reporting requirements.
Tradeoffs
This provision balances the administrative burden on research institutions with the benefit of increased transparency and resource sharing for the broader scientific community, aiming to optimize the use of federally funded research materials.
Sec. 4, adding Sec. 417H and 417I to Subpart 1 of part C of title IV of the Public Health Service Act
Glioblastoma Therapeutics Network and Cellular Immunotherapy Team Science Award
This section directs the Director of the National Cancer Institute to establish a Glioblastoma Therapeutics Network to evaluate therapeutic agents from pre-clinical development through early-phase clinical trials, authorizing $50 million annually for fiscal years 2026-2030. It also mandates competitive awards for a multi-institutional team science approach to develop brain tumor related cellular immunotherapy, including CAR-T treatments, authorizing $10 million annually for the same period.
Sec. 5, adding Sec. 399V-8 to Part P of title III of the Public Health Service Act
Cancer Clinical Trials and Biomarker Testing National Public Awareness Campaign
This section directs the Secretary of Health and Human Services to conduct a national campaign to increase awareness among healthcare providers and the public about cancer clinical trials and biomarker testing. Activities include written materials, public service announcements, and targeted communications for high-risk and rural populations. It also establishes a grant program for demonstration projects to evaluate outreach strategies, with $10 million authorized for the period of fiscal years 2026-2030.
Sec. 6, adding Sec. 409K to Part B of title IV of the Public Health Service Act
Pilot Programs for Brain Tumor Survivor Care
This section authorizes the NIH Director to award grants to eligible entities (such as medical schools, children's hospitals, and cancer centers) to establish pilot programs. These programs will develop, study, or evaluate approaches for monitoring and caring for adult and pediatric brain tumor survivors throughout their lifespan, including post-treatment care transition and coordination. $5 million is authorized annually for fiscal years 2026-2030.
Sec. 7
FDA Guidance to Ensure Brain Tumor Patient Access to Clinical Trials
This section mandates the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance within one year of enactment. This guidance will identify ways to minimize the potential exclusion of brain tumor patients and patients with rare and recalcitrant cancers from clinical trials evaluating treatments for other indications.
Directs the Director of the National Cancer Institute to ensure an orderly transition from the existing Glioblastoma Therapeutics Network to the new research program authorized by the bill, ensuring consistency with previous policies and procedures.
Sec. 4(b)
Why it matters:This is standard legislative practice to ensure continuity and avoid disruption when establishing new programs that supersede or formalize existing ones, aiming for a smooth administrative handover.
Case for: Ensures that valuable ongoing research and established best practices within the existing network are preserved and integrated into the new, expanded program, maximizing efficiency and minimizing loss of momentum during the transition.
Case against: No specific case against; this is a technical provision for smooth administration.
Estimated impact: Ensures the continuity of a significant research program, preventing potential delays or inefficiencies during the transition period and preserving institutional knowledge.
Defines 'biospecimen' for the purpose of reporting requirements as a brain tumor tissue, cerebral spinal fluid, or other specimen type listed by the Specimen Resource Locator of the National Cancer Institute (or a successor database).
Sec. 3(a)(2)
Why it matters:This is standard legislative practice to incorporate existing agency definitions and databases by reference, avoiding the need to enumerate a potentially exhaustive and evolving list within the statute itself.
Case for: Ensures that the scope of biospecimens covered by the reporting requirements is consistent with established scientific and NCI standards, allowing for flexibility as scientific practices evolve without requiring statutory amendment.
Case against: No specific case against, though some might argue that relying on external definitions can make the law less self-contained and potentially subject to changes outside direct legislative control.
Estimated impact: Determines the precise scope of biospecimen collections subject to the new transparency requirements, affecting numerous NIH-funded research projects and their administrative obligations.
Allows funds from pilot programs for brain tumor survivor care to be used for designing and evaluating tools, including those generated by artificial intelligence and machine learning, to support the secure electronic transfer of treatment information and care summaries.
Sec. 6(b)(3)(E)
Why it matters:It is a specific technological detail within a broader programmatic authorization, reflecting an intent to modernize care coordination without making it the sole or primary focus of the section.
Case for: Proponents argue that leveraging advanced technologies like AI and machine learning can significantly improve the efficiency and security of health information transfer, leading to better coordinated and more effective survivor care.
Case against: No specific case against, but some might raise concerns about data privacy, algorithmic bias, or the cost-effectiveness of developing such tools within pilot programs, especially if not scaled effectively.
Estimated impact: Potentially modernizes health information exchange for brain tumor survivors, improving care coordination and reducing administrative burdens for healthcare providers.