The Bolstering Research And Innovation Now (BRAIN) Act aims to accelerate brain tumor research, improve patient access to clinical trials and specialized care, and enhance long-term survivor support through new funding, transparency requirements, and public awareness campaigns.
Brian Fitzpatrick
Representative
PA-1
The Bolstering Research And Innovation Now (BRAIN) Act aims to significantly advance the fight against brain tumors by increasing research funding and improving patient access to care. This legislation establishes new networks for glioblastoma research, creates a public database for tracking biospecimens, and launches a national awareness campaign about clinical trials. Furthermore, the Act funds pilot programs to improve long-term care for survivors and directs the FDA to ensure brain tumor patients are not unfairly excluded from relevant clinical trials.
The new Bolstering Research And Innovation Now Act—or the BRAIN Act—is a major push to tackle brain tumors, especially the most aggressive types like glioblastoma. This legislation immediately sets out to fix what Congress calls a "grim" situation, noting that despite decades of effort, the survival rate for malignant brain tumors hasn't budged much, and for glioblastoma, it’s still tragically low at just 6.9 percent. The bill’s core purpose is to inject dedicated funding into research, make existing scientific resources easier to find, and improve long-term care for survivors.
One of the biggest hurdles in cancer research is simply finding and accessing existing biological samples (biospecimens). Think of it like trying to build a complex engine when half the parts are sitting in different garages across the country, and you don't even have an inventory list. Section 3 of the BRAIN Act tries to solve this by requiring the NIH to create a public, searchable website detailing every brain tumor biospecimen collection purchased or funded with federal money. If an institution holds samples when this law passes, they have 180 days to report it; new collections must be reported within 60 days. This is huge for researchers, who will now have a clear map of available resources, potentially speeding up discoveries. For institutions that repeatedly or seriously fail to report, the NIH is given the authority to withhold future funding, which is a significant enforcement mechanism.
This bill doesn't just shuffle papers; it authorizes serious money for specific, cutting-edge research. Section 4 establishes two new, competitive funding streams. First, it authorizes $50,000,000 annually from 2026 through 2030 for a new Glioblastoma Therapeutics Network. This network will fund teams across multiple institutions to take new glioblastoma treatments from the lab directly into early-phase human trials. Second, it authorizes $10,000,000 annually for the same period specifically for a Cellular Immunotherapy Team Science Award. This is aimed squarely at advancing treatments like CAR T-cell therapy for both adult and pediatric brain tumors. This dedicated, multi-year funding stream offers stability that researchers need to pursue high-risk, high-reward projects.
For patients and their families, navigating clinical trials and understanding modern diagnostic tools can feel like learning a new language under pressure. Section 5 mandates a new national public awareness campaign about cancer clinical trials and biomarker testing. This campaign targets both the public and healthcare providers, ensuring materials are culturally and linguistically appropriate. The goal is to demystify these options—like what biomarker testing is and why it’s critical for personalized treatment—and encourage people to talk to their doctors about them. The bill authorizes $10 million over five years for this campaign and related demonstration projects, aiming to close the knowledge gap that often prevents patients from accessing the best available care.
Surviving a brain tumor is just the start of a long journey, often involving complex follow-up care. Section 6 addresses this by setting up pilot programs to develop and test new models for monitoring and caring for brain tumor survivors, both children and adults. The NIH will award grants to institutions—like children’s hospitals and cancer centers—to study things like team-based care models, mental health support, and, crucially, tools (potentially AI-driven) to securely share treatment summaries and follow-up plans with the survivor’s primary care doctor. This is designed to smooth out the often-bumpy transition from cancer specialist to general practitioner, ensuring that long-term risks are managed effectively. This effort is backed by an authorization of $5,000,000 annually from 2026 through 2030.
Finally, Section 7 tackles a systemic issue: brain tumor patients and those with other rare cancers are sometimes automatically excluded from clinical trials for treatments that could potentially help them, simply because the trial is focused on a different disease. The BRAIN Act requires the FDA to issue guidance within one year to help researchers and the FDA identify and correct these unfair exclusion practices. This provision aims to ensure that if a drug being tested for, say, a neurological disorder could benefit a brain tumor patient, that patient has a fair shot at accessing the trial, removing a blanket barrier that currently exists in many study protocols.