QuesGen support of a Neuroscience Center of Excellence

American Brain Coalition’s initiative to establish a “Neuroscience Center of Excellence”

July 15, 2021 

The Honorable Diana DeGette The Honorable Fred Upton 2111 Rayburn House Office Building 2183 Rayburn House Office Building Washington, D.C. 20515 Washington, D.C. 20515 

Dear Congresswoman DeGette and Congressman Upton: 

On behalf of the American Brain Coalition and the 107 undersigned organizations, we write to offer our  strong support for Section 306 of the 21st Century Cures 2.0 proposal to authorize a new intercenter  institute at the Food and Drug Administration (FDA) focusing on high prevalence and burdensome  diseases, like those affecting the brain and central nervous system (CNS). The Brain Research through  Advancing Innovative Neurotechnologies (BRAIN) Initiative, created through 21st Century Cures Act, has  set the nation on a course towards unprecedented neuroscience discovery. Despite these advances,  patients continue to lack access to enough safe and effective treatments for brain and CNS conditions  due, in part, to the unique regulatory challenges facing treatments that target the body’s most complex  organ system. A Neuroscience Center of Excellence will allow the FDA to consolidate its neuroscience  expertise to create the guidance and processes necessary to ease the review and approval of safe and  effective brain and CNS treatments.  

Brain and CNS diseases impose staggering personal and financial costs on Americans. Nearly one in five  U.S. adults – more than 50 million – live with a mental illness, disproportionately impacting women,  people reporting two or more races, and individuals under age fifty.1 Neuropsychiatric disorders are also  the leading cause of disability in the nation, making up 18.7% of years lost to disability and premature  death.2 Neurological conditions are troublingly prevalent as well – twenty million Americans suffer from  a neurological condition, with 16% of households including an individual with a brain impairment.3 Brain  and CNS diseases also harm older Americans, with more than one in nine people over age 65 having  Alzheimer’s dementia.4The enormous personal costs of brain and CNS conditions also translate into  financial hardship for individuals and families and burden the U.S. economy. Brain disorders and  diseases cost the U.S. more than $1.5 trillion per year,5a significant portion of which is borne by the Medicare program. Seven of the twenty-one chronic conditions tracked by the Centers for Medicare and  

1 National Institute of Mental Health, Mental Illness, at: https://www.nimh.nih.gov/health/statistics/mental-illness2 Office of Disease Prevention and Health Promotion, Mental Health and Mental Disorders, at:  https://www.healthypeople.gov/2020/topics-objectives/topic/mental-health-and-mental-disorders3S. Pal, Incidence and Prevalence of Major Neurologic Disorders. US Pharm, at:  

https://www.uspharmacist.com/article/incidence-and-prevalence-of-major-neurologic-disorders 4 Alzheimer’s Association, Facts and Figures, at: https://www.alz.org/alzheimers-dementia/facts-figures5Information Technology & Innovation Foundation, A Trillion-Dollar Opportunity: How Brain Research Can Drive  Health and Prosperity,

Medicaid Services are related to the brain, representing an average annual cost of $23,325 per Medicare  beneficiary – higher than the average cost for all other chronic conditions.6 

Sadly, SARS-CoV-2 and the ongoing COVID-19 pandemic have only exacerbated the burden of brain and  CNS conditions. During the pandemic, 40% of American adults have reported symptoms of anxiety or  depression, up from 10% in 2019.7The COVID-19 pandemic has also worsened the ongoing opioid  epidemic, with monthly overdose deaths jumping from 6,638 in January 2020 to 9,362 in May 2020 – an  increase of more than 40%.8The SARS-CoV-2 virus itself also harms the brain and CNS in a variety of  ways. A recent study found that nearly one third of patients diagnosed with COVID-19 were diagnosed  with a psychiatric or neurologic condition within six months of contracting COVID-19.9 COVID-19  patients also report a wide variety of psychiatric and neurological symptoms, including strokes,  psychosis, delirium, and loss of smell and taste.  

Despite the enormous prevalence and impact of brain and CNS conditions, there remains a troubling  lack of effective treatments that go beyond symptom mitigation to address the underlying disease.  Product development is difficult for any disease or disorder, but brain and CNS conditions suffer from  greater failures and more costly clinical trials than others.10 Brain-targeting drugs, devices, and other  therapeutics reviewed by the FDA are approved at a much lower rate than those for other disease areas,  with one recent study finding that the mean approval phase time for CNS compared to non-CNS was an astonishing 57% longer.11 Another recent report indicated that the probability of a drug successfully  making its way through a Phase 1 clinical trial to the point of approval is only 15% for brain and CNS  treatments —compared to 32% for ophthalmology, 25% for cardiovascular problems, and 25% for  infectious disease.12 

To respond to these unique challenges and spur innovation in safe and effective treatments for brain  diseases and disorders, FDA should establish a Neuroscience Center of Excellence using the intercenter  institute authority proposed in the Cures 2.0 Discussion Draft. Building upon the successful  implementation of the 21st Century Cures Act’s Oncology Center of Excellence, a Neuroscience Center of  Excellence will similarly create opportunities for innovation in the development and regulation of  treatments for brain diseases and disorders, giving patients access to more effective treatment options.  Creating a Neuroscience Center of Excellence could simplify regulatory review of brain-focused  

6 Center for Medicare & Medicaid Services Chronic Conditions Utilization/Spending State Level: All Beneficiaries  2017. The average per capita spending for a chronic condition is $22,099. 

7 N. Panchal et al., The Implications of COVID-19 for Mental Health and Substance Use, at:  https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-19-for-mental-health-and substance-use/.  

8J.C. Baumgartner & D.C. Radley, The Spike in Drug Overdose Deaths During the COVID-19 Pandemic and Policy  Options to Move Forward, at: https://www.commonwealthfund.org/blog/2021/spike-drug-overdose-deaths during-covid-19-pandemic-and-policy-options-move-forward.  

9 M. Taquet, et al. 6-month neurological and psychiatric outcomes in 236,379 survivors of COVID-19: a  retrospective cohort study using electronic health records. Lancet Psychiatry, at:  

https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(21)00084-5/fulltext10 J.A. Dimasi, CNS drugs take 20% longer to develop and to approve vs. non-CNS drugs. Tufts Center for the Study  of Drug Development. 

11 See Bio, Clinical Development Success Rates and Contributing Factors 2011-2020, at:  https://www.bio.org/clinical-development-success-rates-and-contributing-factors-2011-2020; J.A. Dimasi, CNS  drugs take 20% longer to develop and to approve vs. non-CNS drugs. Tufts Center for the Study of Drug  Development. 

12 C. Heem Wong, et al. Estimation of clinical trial success rates and related parameters. Biostatistics, kxx069.

products, allowing federal and private investments in brain research to more quickly translate into safe  and effective treatments for brain and CNS diseases and disorders. 

In authorizing of a Neuroscience Center of Excellence, Cures 2.0 will build upon the successes of the 21st  Century Cures Act by creating an environment for regulatory innovation that speeds access to safe and  effective treatments and cures for brain disease. Doing so will relieve stress on an overburdened  Medicare program and spur innovation – both in biomedical research and the regulation of brain and  CNS treatments. We thank you for including the authority to create an additional intercenter institute focusing on high prevalence and burdensome diseases in Cures 2.0 and look forward to the enactment  of this important provision as the bill moves through the legislative process.  


American Brain Coalition 

Alliance for Aging Research 

Alliance for Patient Access 

ALS Association 

Alzheimer’s Impact Movement 

American Academy of Addiction Psychiatry 

American Academy of Neurology 

American Association for Geriatric Psychiatry 

American Brain Foundation 

American Brain Tumor Association 

American College of Neuropsychopharmacology 

American Epilepsy Society 

American Headache Society 

American Neurological Association (ANA) 

American Parkinson Disease Association 

American Psychiatric Association 

American Society of Clinical Psychopharmacology 

American Society of Neuroradiology (ASNR) 

Anxiety and Depression Association of America  

Association of University Professors of Neurology 

Autoimmune Encephalitis Alliance, Inc. 

Brain & Behavior Research Foundation 

Brain Aneurysm Foundation 

Brain Injury Association of America 

Brian Grant Foundation 

Bridge the Gap – SYNGAP Education and Research Foundation 

Caregiver Action Network 

Center for BrainHealth 

Center for Law, Brain & Behavior at Massachusetts General Hospital 

Child Neurology Foundation 

Childhood Brain Tumor Foundation 

CJD Foundation 

Cohen Veterans Bioscience 

Cure Alliance for Mental Illness 

Cure Alzheimer’s Fund 

CURE Epilepsy 

Cure Sanfilippo Foundation 



Davis Phinney Foundation 

Dementia Society of America 

Depression and Bipolar Support Alliance 

Down with Dystonia 

Dup15q Alliance 

Dyspraxia USA 

Dystonia Medical Research Foundation 

Epilepsy Foundation 

FND Hope 

Focused Ultrasound Foundation 

Hawaii Parkinson Association 

Headache and Migraine Policy Forum 


Hope for HIE 

Huntington’s Disease Society of America 

Hydrocephalus Association 

Inadcure Foundation  

International Alliance for Pediatric Stroke 

International Bipolar Foundation 

International Essential Tremor Foundation 

International Rett Syndrome Association 

LEAD Coalition (Leaders Engaged on Alzheimer’s Disease) Les Turner ALS Foundation 

Looms for Lupus 

Lundbeck Pharmaceuticals LLC 

Lupus and Allied Diseases Association, Inc. 

M-CM Network 

MdDS Balance Disorder Foundation 

MLD Foundation 

Movement Disorders Policy Coalition 

National Alliance on Mental Illness 

National Aphasia Association 

National Association of State Head Injury Administrators (NASHIA) National Ataxia Foundation 

National Headache Foundation 

National MPS Society 

National Multiple Sclerosis Society 

National Organization for Tardive Dyskinesia 

National Tay-Sachs & Allied Diseases Association (NTSAD) NBIA Disorders Association 

Neurocrine Biosciences, Inc 

Neuropathy Action Foundation 

NORSE Institute 

Northwest Noggin 

One Mind 

Oregon Health & Sciences University 

Parkinson and Movement Disorder Alliance (PMD Alliance) Parkinson Association of the Rockies 

Parkinson’s Foundation

Patrick Risha CTE Awareness Foundation  

Phelan-McDermid Syndrome Foundation 

QuesGen Systems, Inc. 


Ring14 USA 

Sage Therapeutics 

Schizophrenia and Related Disorders Alliance of America  SLC6A1 Connect 

Spina Bifida Association 

Sturge-Weber Foundation 

SynGAP Research Fund, Inc. 

Teva Pharmaceuticals 

The Association for Frontotemporal Degeneration 

The Brain Donor Project 

The Brain Recovery Project: Childhood Epilepsy Surgery Foundation The EndBrainCancer Initiative (EBCI) 

The Gerontological Society of America 

The Michael J. Fox Foundation for Parkinson’s Research The STARR Coalition 

United Cerebral Palsy