Sec. 2. Findings
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/bill/117/s/3427/is/section-2·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Congress finds the following: Neuroscience at the Food and Drug Administration encompasses a broad range of neurological and psychiatric diseases and disorders, including— addiction; Alzheimer’s disease and other neurodegenerative conditions that cause dementia; amyotrophic lateral sclerosis; autism spectrum disorder, Down syndrome, and other neurodevelopmental disorders; bipolar disorder; brain aneurysms; brain tumors; cerebral palsy; anxiety and depression; dyspraxia; dystonia; epilepsy and other seizure disorders; hereditary brain and central nervous system diseases; headaches and migraine disease;
Huntington’s disease; multiple sclerosis; pain; Parkinson’s disease and other movement disorders, including parkinsonisms; personality disorders; psychotic disorders; traumatic brain injury and chronic traumatic encephalopathy; and rare diseases that impact the brain and central nervous system. Neurological and psychiatric diseases and disorders are highly prevalent. According to the National Institutes of Health, neurological disorders affect an estimated 50,000,000 people in the United States each year, and 51,500,000 adults in the United States live with a mental illness.
The prevalence of neuroscience diseases and disorders continues to grow. The Centers for Disease Control and Prevention forecasts that the burden of dementias in the United States will double by 2060 to 13,900,000 people, which will be 3.3 percent of the population. Neurological and psychiatric diseases and disorders have a significant impact on health care expenditures and the United States economy as a whole. The impact of common neurological diseases, including Alzheimer’s disease and Parkinson’s disease, on the United States economy is estimated by the American Neurological Association at over $789,000,000,000.
Factors associated with the COVID–19 pandemic, including job loss and social isolation, have exacerbated the prevalence and impact of psychiatric diseases and disorders. According to the Centers for Disease Control and Prevention, during the pandemic, more than one-third of adults in the United States reported symptoms of anxiety or depression. The National Institute of Neurological Disorders and Stroke has recognized that the SARS–CoV–2 virus can lead to serious neurological complications, such as anosmia, headache, impaired consciousness, and stroke, which may affect individuals’ ability to function or work after the pandemic ends.
Despite the large societal need, medical products for neurological and psychiatric diseases and disorders are approved by the Food and Drug Administration at a much lower rate than products for other disease areas. According to a 2018 study conducted by the Tufts Center for the Study of Drug Development, central nervous system drugs take 20 percent longer to develop and approve than non-central nervous system drugs.