[Congressional Record Volume 167, Number 217 (Thursday, December 16, 2021)]
[Senate]
[Pages S9263-S9264]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS (for herself and Mr. Lujan):
  S. 3427. A bill to authorize the Secretary of Health and Human 
Services to establish a Neuroscience Center of Excellence; to the 
Committee on Health, Education, Labor, and Pensions.
  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

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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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