[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3427 Introduced in Senate (IS)]
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117th CONGRESS
1st Session
S. 3427
To authorize the Secretary of Health and Human Services to establish a
Neuroscience Center of Excellence.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 16, 2021
Ms. Collins (for herself and Mr. Lujan) 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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Neuroscience Center of Excellence
Act of 2021''.
SEC. 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.
SEC. 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:
``SEC. 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.
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