HR3491

The DeOndra Dixon INCLUDE Project Act of 2025, HR3491, establishes the 'INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE Project' (INCLUDE Project) within the NIH. This program mandates expanded research, training, and investigation into Down syndrome, including high-risk/high-reward research on trisomy 21 effects, cohort studies, clinical trials for novel interventions, research on biological mechanisms, and improved diagnosis and treatment of co-occurring conditions like Alzheimer's disease and autoimmunity. The bill's referral to the House Committee on Energy and Commerce, with bipartisan sponsorship including Ms. DeGette (D-CO-1) and Mr. Hudson (R-NC-9), indicates a standard legislative path for health initiatives with moderate momentum. The bill does not specify an appropriation amount, but it directs the NIH to carry out the program, implying a reallocation or increase in federal research funding for Down syndrome. This funding will flow through NIH grants to academic institutions, research hospitals, and private companies engaged in relevant research. Diagnostic companies providing genetic sequencing and biomarker identification services are positioned to capture contracts for research support. Pharmaceutical companies with existing pipelines or research capabilities in neurological disorders, developmental conditions, and Alzheimer's disease will see increased opportunities for grant funding and clinical trial participation. Historically, increased NIH funding for specific disease research has led to advancements and commercial opportunities. For example, the Alzheimer's Accountability Act of 2014 (Public Law 113-196) directed the NIH to prioritize Alzheimer's research. Following this, NIH funding for Alzheimer's research increased from approximately $500 million in 2014 to over $3 billion by 2021. This sustained funding led to increased R&D in the sector, benefiting companies like Biogen ($BIIB) and Eli Lilly ($LLY) through expanded research and clinical trial opportunities, though direct stock impacts are tied to drug approval milestones rather than funding alone. The 21st Century Cures Act of 2016 also boosted NIH funding for various research initiatives, including the BRAIN Initiative, which saw increased investment in neuroscience research. Specific winners include companies providing genetic sequencing and diagnostic services, such as Illumina ($ILMN) and Thermo Fisher Scientific ($TMO), as well as clinical diagnostic labs like LabCorp ($LH) and Quest Diagnostics ($DGX). Pharmaceutical companies with strong neurological pipelines or research interests in Alzheimer's disease, such as Merck ($MRK), Pfizer ($PFE), Eli Lilly ($LLY), Biogen ($BIIB), and Vertex Pharmaceuticals ($VRTX) (given its focus on genetic diseases), stand to gain from expanded research grants and clinical trial opportunities. There are no clear losers from this bill, as it expands research funding without imposing new regulations or restrictions. This bill is currently in the House Committee on Energy and Commerce. The next step is committee consideration, which may include hearings and markups. If it passes committee, it will move to the House floor for a vote. If passed by the House, it proceeds to the Senate. The timeline for passage is uncertain but typically takes several months to over a year for health-related legislation. The bill's bipartisan sponsorship improves its chances of moving through the legislative process.