II 117th CONGRESS 1st Session S. 3427 IN THE SENATE OF THE UNITED STATES December 16, 2021 Ms. Collins (for herself and Mr. Luján ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To authorize the Secretary of Health and Human Services to establish a Neuroscience Center of Excellence.

1. Short title This Act may be cited as the Neuroscience Center of Excellence Act of 2021 . 2. Findings Congress finds the following: (1) Neuroscience at the Food and Drug Administration encompasses a broad range of neurological and psychiatric diseases and disorders, including— (A) addiction; (B) Alzheimer’s disease and other neurodegenerative conditions that cause dementia; (C) amyotrophic lateral sclerosis; (D) autism spectrum disorder, Down syndrome, and other neurodevelopmental disorders; (E) bipolar disorder; (F) brain aneurysms; (G) brain tumors; (H) cerebral palsy; (I) anxiety and depression; (J) dyspraxia; (K) dystonia; (L) epilepsy and other seizure disorders; (M) hereditary brain and central nervous system diseases; (N) headaches and migraine disease; (O) Huntington’s disease; (P) multiple sclerosis; (Q) pain; (R) Parkinson’s disease and other movement disorders, including parkinsonisms; (S) personality disorders; (T) psychotic disorders; (U) traumatic brain injury and chronic traumatic encephalopathy; and (V) rare diseases that impact the brain and central nervous system. (2) 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. (3) 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. (4) 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. (5) 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. (6) 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. (7) 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. 3. Establishment of a Neuroscience Center of Excellence (a) Establishment required The first sentence of section 1014(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399g(a) ) is amended by inserting , at least 1 of which shall be focused on neuroscience diseases and disorders (as defined in section 1015) before the period at the end. (b) Timing of establishment Subsection (c) of section 1014 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399g(c) ) is amended to read as follows: (c) Timing Not later than 1 year after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall establish, in accordance with this section and section 1015, an Institute under subsection (a) focused on neuroscience diseases and disorders, to be known as the Neuroscience Center of Excellence. . (c) Activities Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq. ) is amended by adding at the end the following: 1015. Neuroscience Center of Excellence (a) Activities The Neuroscience Center of Excellence established under section 1014(a), shall— (1) carry out the activities described in section 1014(a); (2) coordinate collaborations among the Centers (within the meaning of section 1014(a)) and stakeholders to support the development of medical products for neuroscience diseases and disorders; (3) establish and carry out the programs described in subsection (c); and (4) issue reports to Congress on the activities of the Neuroscience Center of Excellence, as described in subsection (d). (b) Definitions In this section: (1) Neuroscience diseases and disorders The term neuroscience diseases and disorders means— (A) addiction; (B) Alzheimer’s disease and other neurodegenerative conditions that cause dementia; (C) amyotrophic lateral sclerosis; (D) autism spectrum disorder, Down syndrome, and other neurodevelopmental disorders; (E) bipolar disorder; (F) brain aneurysms; (G) brain tumors; (H) cerebral palsy; (I) anxiety and depression; (J) dyspraxia; (K) dystonia; (L) epilepsy and other seizure disorders; (M) hereditary brain and central nervous system diseases; (N) headaches and migraine disease; (O) Huntington’s disease; (P) multiple sclerosis; (Q) pain; (R) Parkinson’s disease and other movement disorders, including parkinsonisms; (S) personality disorders; (T) psychotic disorders; (U) traumatic brain injury and chronic traumatic encephalopathy; and (V) rare diseases that impact the brain and central nervous system. (2) Medical product The term medical product means a drug, biological product, or device, or a combination product described in section 503(g). (3) Patient experience data The term patient experience data has the meaning given such term in section 569C(c). (c) Programs The Neuroscience Center of Excellence shall establish and implement the following programs: (1) Neuroscience therapeutics program (A) Public engagement (i) Public meeting Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , and not less than once per year thereafter, the Secretary shall convene a public meeting of stakeholders (including scientists, researchers, patient advocacy organizations, disease research foundations, and representatives of the drug and device industries) to identify and make recommendations to address current and emerging regulatory science and public policy challenges associated with developing medical products for neuroscience diseases and disorders. Issues addressed during such meetings shall include— (I) methods to support the accelerated qualification of appropriate biomarkers and endpoints, including predictive biomarkers and endpoints, for neuroscience diseases and disorders; and (II) novel drug development methodologies and study designs to better support the rapid development and approval of medical products for neuroscience diseases and disorders. (ii) Report Not later than 3 months after the conclusion of each public meeting under clause (i), the Secretary shall publish a report identifying the challenges and opportunities for rapid improvement discussed during such public meeting, and as applicable, any recommendations to Congress regarding how to address such challenges and ensure that patients benefit from optimizing development of medical products for neurosciences diseases and disorders. The Secretary shall make such report public on the website of the Department of Health and Human Services. (B) Guidance Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall issue one or more final guidances that address— (i) recommendations to sponsors of medical products for neuroscience diseases and disorders regarding master protocols to simultaneously evaluate more than 1 investigational medical product or more than 1 type of disease or disorder within the same overall trial structure, as well as other novel or collaborative study designs and approaches; and (ii) approaches that may be used to incorporate clinical outcome assessments, including patient-reported outcomes, into endpoints for the development of medical products for neuroscience diseases and disorders. (2) Neuroscience patient-focused drug development program (A) In general The Secretary shall establish, within the Neuroscience Center of Excellence, a program to facilitate the collection of patient experience data, and the systematic use of such data and related information, in the development of medical products for neuroscience diseases and disorders. (B) Public engagement Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , and not less than once per year thereafter, the Secretary shall convene stakeholders (including patient advocacy groups and disease research foundations) for a public workshop. Such workshop shall— (i) educate stakeholders on current initiatives and activities at the Neuroscience Center of Excellence; (ii) solicit feedback from stakeholders on ongoing initiatives and activities at the Neuroscience Center of Excellence; and (iii) provide an opportunity for stakeholders to discuss their personal experiences, including with respect to symptoms, daily impact, and current approaches to treatment for neuroscience diseases and disorders. (C) Study Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall conduct a study on methods to assess the patient experience in the development of medical products for neuroscience diseases and disorders. The Secretary shall make a report summarizing the results of such study public on the website of the Department of Health and Human Services. (D) Guidance Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall issue final guidance with recommendations on the collection of patient experience data (as defined in section 569C of the Federal Food, Drug, and Cosmetic Act), and the use of such data and related information, in the development of medical products for neuroscience diseases and disorders. (3) Neuroscience natural history studies program (A) Guidance Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall issue final guidance with recommendations for sponsors on implementing natural history studies that can be used to support the development of medical products for neuroscience diseases and disorders. (B) Definition In this paragraph, the term natural history study means a preplanned observational study intended to track the course of the disease. (4) Digital health technologies program (A) Guidance Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall issue final guidance addressing approaches to— (i) using digital technologies and digital endpoints in clinical trials evaluating medical products for neuroscience diseases and disorders; and (ii) using digital technologies for the treatment of such diseases and disorders. (5) COVID–19 impacts program (A) Public meeting (i) In general Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall convene not fewer than 2 public meetings for stakeholders (including scientists, researchers, health care providers, academics, members of the regulated industry, patient advocacy organizations, and disease research foundations) to discuss the impact of COVID–19 on neuroscience diseases and disorders. (ii) Topics The topics discussed at the meeting under clause (i) shall include— (I) the impact of the SARS–CoV–2 virus on patients diagnosed with such diseases and disorders, without regard to whether such diagnoses occurred before or after such patient contracted the SARS–CoV–2 virus; (II) the indirect impact of the COVID–19 pandemic on such diseases and disorders, including the effects of social isolation and heightened levels of stress and anxiety for those with neuroscience disease and disorder diagnoses; and (III) strategies for the rapid development of medical products to address the direct and indirect impacts of COVID–19 on such diseases and disorders, including real-world data collection and real-world evidence development. (B) Report Not later than 1 year after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall publish a report on the direct and indirect impacts of COVID–19 on neuroscience diseases and disorders including, as applicable, any recommendations to Congress on the development of medical products intended to address the impact of COVID–19 for individuals with such conditions. The Secretary shall make such report public on the website of the Department of Health and Human Services. (6) Ensuring equity in neuroscience program (A) Public meeting Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall convene a public meeting of stakeholders whose experience directly relates to patients with neuroscience diseases and disorders (including scientists, health care providers, academics, members of the regulated industry, patient advocacy organizations, and disease research foundations) to discuss how to promote equity and inclusion of traditionally underrepresented populations in the research and development of medical products for neuroscience diseases and disorders. (B) Guidance Not later than 2 years after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , the Secretary shall issue guidance for industry on how to ensure greater diversity in clinical trials for neuroscience diseases and disorders medical products. Such guidance shall consider the feedback and recommendations from the public meeting under subparagraph (A) the study under section 3(d) of the Neuroscience Center of Excellence Act of 2021 . (d) Report Not later than 1 year after the date of enactment of the Neuroscience Center of Excellence Act of 2021 , and annually thereafter, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the activities of the Neuroscience Center of Excellence. Such report shall include— (1) the number of medical products for neuroscience diseases and disorders that were approved by the Food and Drug Administration in the previous 5 calendar years; (2) a summary of challenges to developing medical products for neuroscience diseases and disorders, and as applicable, recommendations to Congress on how to address such challenges; and (3) the direct and indirect impacts of the COVID–19 pandemic on neuroscience diseases and disorders. (e) Authorization of appropriations To carry out this section, there are authorized to be appropriated $25,000,000 for the period of fiscal years 2023 through 2027. . (d) GAO study Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall— (1) complete a study that reviews the participation of traditionally underrepresented populations in clinical trials for medical products (as defined in section 1015 of the Federal Food, Drug, and Cosmetic Act, as added by section 3) for the treatment or diagnosis of neuroscience diseases and disorders (as defined in such section 1015); and (2) submit a report to Congress on the results of such study, including recommendations on potential changes in practices and policies to improve participation by populations that have been traditionally underrepresented in such trials.