[Congressional Record Volume 167, Number 171 (Thursday, September 30, 2021)]
[Extensions of Remarks]
[Page E1050]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]





  INTRODUCTION OF THE BRINGING REGULATORY ADVANCES INTO NEUROSCIENCE 
                          (BRAIN) ACT OF 2021

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                          HON. EARL BLUMENAUER

                               of oregon

                    in the house of representatives

                      Thursday, September 30, 2021

  Mr. BLUMENAUER. Madam Speaker, today I am pleased to introduce the 
Bringing Regulatory Advances into Neuroscience (BRAIN) Act of 2021.
  Today, brain and central nervous system (CNS) disorders account for 
an incredible burden both on individual patients and their families as 
well as the United States health care system. One in five adults in 
America--more than 50 million people--live with a mental illness while 
20 million Americans suffer from a neurological condition. Brain 
diseases and disorders cost the U.S. more than $1.5 trillion per year, 
a significant portion of which is paid for by the Medicare program. 
Seven of the 21 chronic conditions tracked by the Centers for Medicare 
and Medicaid Services (CMS) are related to the brain and this 
represents an average annual cost of $23,325 per Medicare beneficiary, 
higher than the average cost for all other chronic conditions.
  The BRAIN Act of 2021 would establish a Neuroscience Center of 
Excellence (NCOE) under the Food and Drug Administration. Modeled after 
the FDA's Oncology Center of Excellence, an NCOE would create 
opportunities for innovation in the development and regulation of 
treatments for brain diseases and disorders. By focusing on patients, 
it would ensure that investments in research are more likely to produce 
safe and effective treatments which would provide relief for those who 
have been waiting too long.
  The blueprint for a center of excellence like this was included in a 
discussion draft of 21st Century Cures 2.0, circulated by my colleagues 
Representatives DeGette and Upton. The draft legislation would require 
the FDA to create at least two new intercenter institutes, including 
one focusing on high prevalence and burdensome diseases like those 
affecting the brain and CNS.
  It is clear that there is an enormous need to address these 
conditions and a Neuroscience Center of Excellence would make 
significant progress for people who have been suffering for far too 
long.
  I urge my colleagues to support this bipartisan legislation.

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