BRAIN Act
- Bill Number
- H.R. 2767
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-04-09: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-07-10T08:06:17Z
AI-Generated Summary
Purpose
The BRAIN Act (H.R. 2767), or "Bolstering Research And Innovation Now Act," aims to advance medical research for breakthroughs in brain tumor treatment. It seeks to strengthen research efforts, improve access to specialized care for brain tumors and rare, hard-to-treat cancers, and raise public awareness about treatment options like clinical trials and biomarker testing (a method to identify specific molecules in the body that indicate cancer characteristics).
Key Provisions
- Transparency in Biospecimen Collections (Sec. 3): Requires individuals or entities funded by the National Institutes of Health (NIH) to report details of brain tumor-related biospecimens (such as tissue or fluid samples) to NIH. This creates a public searchable website listing these collections, their descriptions, and contact information to aid research. Existing collections must report within 180 days of enactment; new ones within 60 days. NIH can withhold funding for non-compliance.
- Glioblastoma Therapeutics Network and Cellular Immunotherapy Awards (Sec. 4): Establishes a research program through NIH's National Cancer Institute to fund collaborative studies on glioblastoma (a common, aggressive brain tumor) from early lab testing to initial human trials. It also creates awards for multi-institution teams to develop cellular immunotherapies, including CAR-T (a type of immune cell therapy where T-cells are engineered to target cancer). Authorizes $50 million annually (2026–2030) for the network and $10 million annually for immunotherapy awards. Includes a transition plan for an existing similar program.
- National Awareness Campaign for Clinical Trials and Biomarker Testing (Sec. 5): Directs the Secretary of Health and Human Services (HHS) to launch a campaign educating healthcare providers, patients, and caregivers on cancer clinical trials (research studies testing new treatments) and biomarker testing. Activities include distributing materials, public service announcements, and targeted outreach to high-risk groups (e.g., based on race, ethnicity, or rural location). Also funds demonstration projects via grants to test outreach strategies for brain tumor and cancer patients. Authorizes $10 million (2026–2030).
- Pilot Programs for Brain Tumor Survivors (Sec. 6): Allows NIH to award grants to medical schools, hospitals, cancer centers, and other eligible entities for pilot programs studying long-term care models for adult and pediatric brain tumor survivors. Focuses on monitoring, care coordination, multidisciplinary support (involving multiple specialists), psychosocial programs, and tools like AI for sharing treatment info. Prioritizes diverse geographic and size-based entities. Authorizes $5 million annually (2026–2030).
- FDA Guidance on Clinical Trial Access (Sec. 7): Requires the Food and Drug Administration (FDA), within one year of enactment, to issue guidance minimizing exclusion of brain tumor patients (and those with rare/hard-to-treat cancers) from trials for other diseases, ensuring broader access.
Significant Changes to Existing Law
The Act amends the Public Health Service Act by adding new sections (e.g., 404P for biospecimen reporting, 417H–I for research programs, 399V-8 for awareness campaigns, and 409K for survivor pilots). It builds on existing NIH and FDA frameworks by mandating new reporting, funding mechanisms, and public resources. It transitions an ongoing Glioblastoma Therapeutics Network to a formalized, funded program and introduces specific authorizations of appropriations, which were not previously detailed for these brain tumor initiatives.
Potential Impacts
- Government Agencies: Increases workload and funding for NIH (research coordination, database maintenance, oversight), FDA (guidance development), and HHS (campaign implementation). Authorizes over $750 million total (2026–2030) across programs, potentially straining budgets if not appropriated, but enhancing research efficiency through transparency and collaboration.
- Citizens: Improves access to innovative treatments, clinical trials, and survivor care for the estimated 1 million+ Americans living with brain tumors, including children. Raises awareness to boost trial participation (currently low), potentially leading to better survival rates (stagnant at ~35% for malignant tumors) and quality of life. Targets underserved groups, promoting health equity.
- International Relations: Minimal direct impact; focuses on U.S. domestic research and care, though shared biospecimen data could indirectly support global cancer research collaborations.
Main Stakeholders Affected
- Patients and Families: Brain tumor survivors, especially pediatric and those with glioblastoma or rare cancers, benefit from enhanced research, care models, and awareness.
- Healthcare Providers: Physicians, nurses, and specialists gain tools for better coordination, education, and trial access; rural and minority-serving providers may see more resources.
- Researchers and Institutions: Universities, cancer centers, and hospitals receive funding for collaborative studies, immunotherapy, and pilots, fostering innovation.
- Government and Nonprofits: NIH, FDA, HHS, and organizations like the National Brain Tumor Society drive implementation; nonprofits may partner on campaigns and outreach.
- General Public: All Americans, as brain tumors affect all demographics, with broader benefits for cancer research.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens federal oversight of NIH-funded research via reporting and funding withholding, ensuring compliance without new regulatory burdens. Guidance from FDA could influence drug trial designs, potentially expanding patient rights under existing clinical trial laws. All activities must align with privacy laws (e.g., for biospecimen data) and peer review processes.
- Constitutional: No apparent conflicts; supports the government's role in public health under the general welfare clause, promoting equal access without infringing on individual rights.
- Political: Bipartisan introduction (by Reps. Fitzpatrick, Trahan, Joyce, and Schrier) signals broad support for cancer research funding. Authorizes but does not appropriate funds, leaving allocation to Congress, which could spark debates on healthcare spending priorities amid stagnant brain tumor outcomes. Emphasizes equity for underserved populations, aligning with ongoing political pushes for health disparities reduction.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Fitzpatrick, Brian K. [R-PA-1]
Cosponsors (63)
Rep. Trahan, Lori [D-MA-3], Rep. Joyce, John [R-PA-13], Rep. Schrier, Kim [D-WA-8], Rep. Auchincloss, Jake [D-MA-4], Rep. Lieu, Ted [D-CA-36], Rep. Davids, Sharice [D-KS-3], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Jackson, Jonathan L. [D-IL-1], Rep. Carbajal, Salud O. [D-CA-24], Rep. Tlaib, Rashida [D-MI-12], Rep. Lawler, Michael [R-NY-17], Rep. McBride, Sarah [D-DE-At Large], Rep. Riley, Josh [D-NY-19], Rep. McBath, Lucy [D-GA-6], Rep. Elfreth, Sarah [D-MD-3], Rep. Stevens, Haley M. [D-MI-11], Rep. Sorensen, Eric [D-IL-17], Rep. Gottheimer, Josh [D-NJ-5], Rep. DesJarlais, Scott [R-TN-4], Rep. Budzinski, Nikki [D-IL-13], Rep. Kim, Young [R-CA-40], Rep. Vindman, Eugene Simon [D-VA-7], Del. King-Hinds, Kimberlyn [R-MP-At Large], Rep. Crow, Jason [D-CO-6], Rep. Lee, Summer L. [D-PA-12], Rep. Raskin, Jamie [D-MD-8], Rep. Thompson, Mike [D-CA-4], Rep. Johnson, Julie [D-TX-32], Rep. DelBene, Suzan K. [D-WA-1], Rep. Magaziner, Seth [D-RI-2], Rep. Dingell, Debbie [D-MI-6], Rep. Pettersen, Brittany [D-CO-7], Rep. Soto, Darren [D-FL-9], Rep. Bresnahan, Robert P. [R-PA-8], Rep. Ross, Deborah K. [D-NC-2], Rep. Mullin, Kevin [D-CA-15], Rep. Clarke, Yvette D. [D-NY-9], Rep. Keating, William R. [D-MA-9], Rep. Castor, Kathy [D-FL-14], Rep. Latimer, George [D-NY-16], Rep. Levin, Mike [D-CA-49], Rep. Peters, Scott H. [D-CA-50], Rep. Neguse, Joe [D-CO-2], Rep. Van Orden, Derrick [R-WI-3], Rep. Wasserman Schultz, Debbie [D-FL-25], Rep. Bacon, Don [R-NE-2], Rep. Tonko, Paul [D-NY-20], Rep. Brownley, Julia [D-CA-26], Rep. McCollum, Betty [D-MN-4], Rep. Ryan, Patrick [D-NY-18] and 13 more
Recent Actions
- 2025-04-09: Referred to the House Committee on Energy and Commerce.
- 2025-04-09: Introduced in House
- 2025-04-09: Introduced in House
Bill Versions
- Bolstering Research And Innovation Now Act — issued 2025-04-09 — PDF (18 pages)