BRAIN Act
- Bill Number
- S. 1330
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-04-08: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2026-05-19T11:03:44Z
AI-Generated Summary
Purpose of the Legislation
The BRAIN Act (Bolstering Research And Innovation Now Act) aims to boost research into brain tumor treatments, foster medical breakthroughs, and enhance public awareness and access to specialized care for brain tumors and certain hard-to-treat cancers. It addresses stagnant survival rates, limited treatment options, and gaps in biospecimen sharing, clinical trials, and survivor support.
Key Provisions
- Findings and Purposes (Sec. 2): Outlines statistics on brain tumors (e.g., over 1 million U.S. cases, low survival rates for malignant types like glioblastoma at 6.9% over 5 years) and emphasizes the need for cures, better survival, and quality-of-life improvements. Purposes include strengthening research and improving access to specialized care.
- Transparency for Biospecimen Collections (Sec. 3): Amends the Public Health Service Act to require reporting of NIH-funded brain tumor biospecimens (e.g., tissue or fluid samples used in research). Creates a public searchable website listing these collections' locations, descriptions, and contacts. Existing collections must report within 180 days; new ones within 60 days. Includes oversight, such as withholding funds for non-compliance.
- Glioblastoma Therapeutics Network and Cellular Immunotherapy (Sec. 4): Establishes a National Cancer Institute (NCI) research program via competitive grants to collaborate on glioblastoma treatments from early lab studies to initial human trials. Authorizes $50 million annually (FY 2026–2030). Also funds multi-institution teams for cellular immunotherapies (e.g., CAR-T cell therapy, where immune cells are engineered to target cancer) for adult and pediatric brain tumors, including preclinical and clinical trials. Authorizes $10 million annually (FY 2026–2030). Transitions an existing NCI glioblastoma network to this new program.
- Public Awareness Campaign for Clinical Trials and Biomarker Testing (Sec. 5): Launches a national HHS campaign to educate providers, patients, and caregivers on cancer clinical trials (research studies testing new treatments) and biomarker testing (lab tests identifying genetic markers to guide personalized cancer care). Includes materials, public service announcements, and targeted outreach to high-risk groups (e.g., by race, rural areas). Funds demonstration grants for outreach strategies focused on brain tumors. Authorizes $10 million (FY 2026–2030). Requires consultation with providers, nonprofits, and educators.
- Pilot Programs for Brain Tumor Survivors (Sec. 6): Authorizes NIH awards to entities like medical schools, hospitals, and cancer centers to test care models for adult and pediatric survivors. Focuses on lifelong monitoring, transitions to post-treatment care, multidisciplinary support (e.g., psychological counseling, peer mentoring), and tools like AI for sharing care plans. Prioritizes diverse geographic and size-based recipients. Authorizes $5 million annually (FY 2026–2030).
- FDA Guidance on Clinical Trial Access (Sec. 7): Directs the FDA to issue guidance within one year to reduce exclusion of brain tumor patients (and those with rare, treatment-resistant cancers) from trials for other conditions, promoting broader participation.
Significant Changes to Existing Law
This bill amends the Public Health Service Act by adding new sections (e.g., 404P for biospecimens, 417H/I for research networks, 399V-8 for awareness, 409K for pilots) to expand NIH and NCI programs. It builds on existing efforts like the NCI's Specimen Resource Locator database and glioblastoma network but introduces mandatory reporting, new funding mechanisms (e.g., U19 and U series grants for collaborative research), and public-facing tools. No outright repeals, but it mandates transitions and oversight to integrate with current systems.
Potential Impacts
- Government Agencies: Increases responsibilities and funding for NIH, NCI, HHS, and FDA, including new websites, campaigns, and guidance. Authorizations total up to $75 million annually (FY 2026–2030), contingent on congressional appropriations, potentially straining budgets if not fully funded.
- Citizens: Improves access to research, trials, and survivor care for brain tumor patients (over 1 million affected), families, and high-risk groups, potentially leading to better treatments, earlier detection awareness, and quality-of-life support. Enhances equity in rural and underserved areas.
- International Relations: No direct impacts; focuses on domestic U.S. research and health programs.
Main Stakeholders Affected
- Patients and Families: Brain tumor survivors, those with rare/recalcitrant cancers, children/young adults (leading cancer death cause), and caregivers benefit from research, awareness, and care models.
- Healthcare Providers: Physicians, nurses, hospitals, and specialists gain tools for trials, biomarker testing, and survivor monitoring; required to engage in education and coordination.
- Researchers and Institutions: Universities, cancer centers, and nonprofits receive grants for collaborative studies, immunotherapy, and pilots.
- Government and Nonprofits: NIH, NCI, FDA, HHS, and organizations like the National Brain Tumor Society drive implementation and outreach.
- Public: Broader awareness campaigns target diverse communities, including racial/ethnic minorities and rural populations.
Notable Legal, Constitutional, or Political Implications
- Legal: Relies on existing authorities under the Public Health Service Act; introduces enforceable reporting and funding withholding for compliance, but no new regulatory burdens on private entities beyond NIH grantees. Guidance is advisory, not binding rules.
- Constitutional: Aligns with federal spending power for public health; no apparent free speech, privacy, or equal protection issues, though biospecimen data sharing must comply with health privacy laws (e.g., HIPAA).
- Political: Bipartisan sponsorship (e.g., Sens. Blumenthal, Rounds) signals broad support for cancer research. Authorizations promote innovation without mandating spending, allowing flexibility amid fiscal debates. Could influence future health policy by prioritizing brain tumors amid stagnant progress.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Sen. Blumenthal, Richard [D-CT]
Cosponsors (14)
Sen. Rounds, Mike [R-SD], Sen. Reed, Jack [D-RI], Sen. Barrasso, John [R-WY], Sen. Kelly, Mark [D-AZ], Sen. Coons, Christopher A. [D-DE], Sen. Van Hollen, Chris [D-MD], Sen. Banks, Jim [R-IN], Sen. Alsobrooks, Angela D. [D-MD], Sen. Gillibrand, Kirsten E. [D-NY], Sen. Blunt Rochester, Lisa [D-DE], Sen. Gallego, Ruben [D-AZ], Sen. Daines, Steve [R-MT], Sen. Schiff, Adam B. [D-CA], Sen. Shaheen, Jeanne [D-NH]
Recent Actions
- 2025-04-08: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2025-04-08: Introduced in Senate
Bill Versions
- Bolstering Research And Innovation Now Act — issued 2025-04-08 — PDF (18 pages)