Senators Collins, Lujan Introduce Bill to Spur Research on Neurological Diseases Like Alzheimer’s

Washington, D.C.—In a bipartisan effort to accelerate the prevention, treatment, and cure of neurological diseases, U.S. Senators Susan Collins (R-ME) and Ben Ray Luján (D-NM) introduced the Neuroscience Center of Excellence Act.  The legislation would establish a Neuroscience Center of Excellence at the Food and Drug Administration (FDA) and is modeled after the FDA’s successful Oncology Center of Excellence. 

The new Neuroscience Center of Excellence will establish several programs aimed at supporting innovative research that will encompass more than 20 neurological diseases, from conditions that are tragically all too common, such as Alzheimer’s disease, to conditions that are very rare, such as Huntington’s disease.  These diseases not only exact a human toll, but a financial toll as well.  According to researchers at the University of South Florida, the nine most prevalent and costly diagnosed neurological disorders have an annual total cost of nearly $800 billion.

“Neuroscience is an area of medicine where there is tremendous unmet need, and neurodegenerative diseases are particularly challenging from both a research and a drug development perspective,” said Senator Collins.  “We desperately need to change the trajectory of neurological diseases and renew our focus on promoting research to find effective means of prevention, treatments, and cures for these debilitating conditions that affect millions of Americans and their families.  This legislation Senator Luján and I have introduced would make critical advances for those living with neurological diseases.”

“I’m honored to join Senator Collins to introduce bipartisan legislation to establish a Neuroscience Center of Excellence to address Central Nervous System diseases that impact millions of Americans,” said Senator Luján. “Building on the success of existing Centers of Excellence, this legislation will aid the development of new therapies to better treat Americans.”

The Neuroscience Center of Excellence Act has several components:

• Neuroscience Therapeutics Program (NTP).  The NTP would address the problems related to the development of neuroscience products, including the need for more drug development tools, through the following activities: 1) foster development of biomarkers such as predictive biomarkers; 2) investigate novel endpoints—using both existing and emerging technologies— that more fully characterize the clinical benefit of therapeutics; 3) evaluate novel drug development programs and pathways that enhance the neuroscience drug development paradigm and account for the unique aspects of neuroscience-related therapeutics; and 4) foster collaborations with patient advocacy, scientific, and professional organizations with expertise in neurosciences to identify and address potential challenges for translating scientific advances at the bench into therapeutic advances for patients.

• Neuroscience Patient-Focused Development Program.  This program would facilitate the collection of patient experience data, and the systematic use of such data and related information, in the development of medical products for neuroscience diseases and disorders.

• Neuroscience Natural History Studies Program.  This program would help inform the design and implementation of natural history studies that can be used to support the development of drugs, biologics, and devices for neuroscience diseases.

• Digital Health Technologies Program.  This program would center on how to better integrate digital health technology tools—such as remote patient monitoring, digital biomarkers, and cloud data acquisition/extraction/storage/transfer—into the neuroscience product review process.

• COVID Impacts Program.  To improve the understanding of the neurological impacts of COVID-19, this program would foster collaboration between the FDA and external stakeholders, including on real world data collection and evidence development.

Click HERE to read the text of the bill.

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