The publication is reproduced in full below:
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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SOURCE: Congressional Record Vol. 167, No. 171
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