Statements on Introduced Bills and Joint Resolutions

Floor Speech

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Ms. COLLINS. Mr. President I rise today with my colleague, Senator Ben Ray Lujan, to introduce the Neuroscience Center of Excellence Act of 2021, legislation that would establish a Neuroscience Center of Excellence at the Food and Drug Administration, FDA. This program would be modeled after FDA's Oncology Center or Excellence, which was authorized through the 2lst Century Cures Act. Building off that successful and bipartisan model, I hope we can make critical advances for those living with neurological diseases.

In July, FDA's Director of the Center for Drug Evaluation and Research testified that 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. I have seen this firsthand as founder and cochairman of the Senate Alzheimer's Disease Caucus. I have vigorously advocated for record funding increases to support additional NIH research over the past 25 years. Over the past year, many have noted the success of Operation Warp Speed and wondered why we can't achieve the same rapid progress in other health conditions.

The Neuroscience Center of Excellence would encompass more than 20 neurological diseases, including conditions that are very rare. For example, Huntington's disease is an inherited disease characterized by the progressive loss of brain and muscle function. It has sometimes been described as having ALS, Parkinson's, and Alzheimer's simultaneously. It is an autosomal dominant condition, so families with a history of Huntington's disease can see it appear in every generation. In Maine, Nancy Patterson has seen Huntington's disease in four generations of family. In addition, I lost a friend and coworker in former Senator Bill Cohen's office to this devastating disease. Sadly, there is no cure.

Through our bill, this new Neuroscience Center of Excellence would establish several programs aimed at supporting innovation. The first is to identify some of the current and emerging regulatory science and public policy challenges associated with developing medical products for neuroscience diseases and disorders through a series of public meetings and guidances. The Center of Excellence would also establish a program to facilitate both the collection and the systematic use of patient experience data in the development of medical products for neuroscience diseases and disorders.

Another component of the Center's work would be around using digital technologies, an area of much promise. In 2018, the National Academies of Medicine Forum on Neuroscience and Nervous System Disorders hosted a workshop on using mobile technology to advance research and treatment of central nervous system disorders. As Dr. William Marks, head of clinical neurology at Verily Life Sciences, observed, the current state of assessing brain disorders is ``exquisitely crude'' and there is a large unmet need for better measures of disease burden that are objective, quantitative, more frequently measured, and in the context of normal life.

Finally, the center would help promote inclusion of traditionally underrepresented populations in the research and development of medical products for neuroscience diseases and disorders through public meetings and industry guidance. Senator Lujan and I have worked together on this issue before as part of our Equity in Neuroscience and Alzheimer's Clinical Trials Act of 2021. Whether the barrier to participation is a distrust of the medical community or logistics concerns like time and travel, we need to overcome those hurdles in order to ensure the best possible science.

Researchers from the University of South Florida looked at the nine most prevalent and costly diagnosed neurological disorders and found the annual cost totaled nearly $800 billion. We desperately need to change this trajectory and renew our focus on these critical unmet needs. I urge my colleagues to support this important legislation.

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