[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6584 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 6584
To direct the Commissioner of Food and Drugs to amend certain
regulations to increase clinical trial diversity, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 3, 2022
Ms. Eshoo (for herself, Mr. Fitzpatrick, and Ms. Kelly of Illinois)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To direct the Commissioner of Food and Drugs to amend certain
regulations to increase clinical trial diversity, and for other
purposes.
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 ``Diverse and Equitable Participation
in Clinical Trials Act'' or the ``DEPICT Act''.
SEC. 2. PREMARKET REPORTING OF DIVERSITY PLANS FOR CLINICAL TRIALS AND
STUDIES.
(a) Drugs.--The Commissioner of Food and Drugs shall issue
regulations revising part 312 of title 21, Code of Federal Regulations,
to require sponsors of applications for an exemption for
investigational use of a drug to include--
(1) in any such application--
(A) the estimated prevalence in the United States
of the disease or condition for which the drug is being
developed or investigated, disaggregated by demographic
subgroup, where such data is available, including age
group, sex, race, and ethnicity;
(B) the sponsor's targets for enrollment in the
clinical trial or trials involved, disaggregated by age
group, sex, race, and ethnicity;
(C) the rationale for the sponsor's enrollment
targets referred to in subparagraph (B), which may
include--
(i) the estimated prevalence referred to in
subparagraph (A);
(ii) what is known about the disease or
condition for which the drug is being developed
or investigated;
(iii) any relevant pharmacokinetic or
pharmacogenomic data;
(iv) what is known about the patient
population, including co-morbidities and
potential barriers to enrolling diverse
participants, such as patient population size
and geographic location; and
(v) any other data or information the
sponsors deems relevant to selecting
appropriate enrollment targets, disaggregated
by demographic subgroup; and
(D) a diversity action plan for how the sponsor
will meet such targets, including demographic-specific
outreach and enrollment strategies, study-site
selection, clinical trial inclusion and exclusion
practices, and any diversity training for trial
personnel; and
(2) in an annual report described in section 312.33 of
title 21, Code of Federal Regulations--
(A) the sponsor's progress in meeting the targets
referred to in paragraph (1)(B); and
(B) if the sponsor does not expect to meet those
targets referred to in paragraph (1)(B)--
(i) any updates needed to be made to the
diversity action plan referred to in paragraph
(1)(D) to meet such targets; or
(ii) the sponsor's justification for why
the sponsor does not expect to meet such
targets, including--
(I) any factors outside of the
sponsor's control, including a lack of
retention of participants;
(II) any differences in the
enrollment targets, disaggregated by
demographic subgroup, and actual
enrollment that the sponsor determines
are insignificant in nature;
(III) potential for selection bias;
and
(IV) information not available to
the sponsor at the time such targets
were chosen, but that impacted
enrollment of diverse participants.
(b) Devices.--The Commissioner of Food and Drugs shall issue
regulations revising part 812 of title 21, Code of Federal Regulations,
to require sponsors of applications for an exemption for
investigational use of a device to include--
(1) in any such application--
(A) a description of the patient population in the
United States expected to use the device, disaggregated
by demographic subgroup, where such data is available,
including age group, sex, race, and ethnicity;
(B) the sponsor's targets for enrollment in the
clinical trial or trials involved, disaggregated by age
group, sex, race, and ethnicity;
(C) the rationale for the sponsor's enrollment
targets referred to in subparagraph (B), which may
include--
(i) the estimated prevalence referred to in
subparagraph (A);
(ii) what is known about the disease or
condition for which the drug is being developed
or investigated;
(iii) any relevant pharmacokinetic or
pharmacogenomic data;
(iv) what is known about the patient
population, including co-morbidities and
potential barriers to enrolling diverse
participants, such as patient population size
and geographic location; and
(v) any other data or information the
sponsors deems relevant to selecting
appropriate enrollment targets, disaggregated
by demographic subgroup; and
(D) a diversity action plan for how the sponsor
will meet such targets, including demographic-specific
outreach and enrollment strategies, study-site
selection, clinical trial inclusion and exclusion
practices, and any diversity training for trial
personnel; and
(2) in an annual report described in section 812.150 of
title 21, Code of Federal Regulations--
(A) the sponsor's progress in meeting those targets
referred to in paragraph (1)(B); and
(B) if the sponsor does not expect to meet those
targets referred to in paragraph (1)(B)--
(i) any updates needed to be made to the
diversity action plan referred to in paragraph
(1)(D) to meet such targets; or
(ii) the sponsor's justification for why
the sponsor does not expect to meet such
targets, including--
(I) any factors outside of the
sponsor's control, including a lack of
retention of participants;
(II) any differences in the
enrollment targets, disaggregated by
demographic subgroup, and actual
enrollment that the sponsor determines
are insignificant in nature;
(III) potential for selection bias;
and
(IV) information not available to
the sponsor at the time such targets
were chosen, but that impacted
enrollment of diverse participants.
(c) Additional Clinical Trial Data.--The Commissioner of Food and
Drugs shall issue regulations revising sections 807.92 and 814.20 of
title 21, Code of Federal Regulations, to require that applications for
devices approved under section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e) and devices cleared under section 510(k)
of such Act (21 U.S.C. 360(k)) whose submission includes clinical
data--
(1) a description of the patient population in the United
States expected to use the device, disaggregated by demographic
subgroup, where such data is available, including age group,
sex, race, and ethnicity; and
(2) in summarizing the clinical investigations involving
human subjects in such applications, a description of study
subjects by demographic subgroup, including age group, sex,
race, and ethnicity.
(d) Deadline for Promulgation.--The Commissioner of Food and Drugs
shall issue--
(1) any proposed rules required under this section not
later than 2 years after the date of the enactment of this Act;
and
(2) any final rules required under this section not later
than 3 years after the date of the enactment of this Act.
SEC. 3. FDA AUTHORITY TO MANDATE POSTAPPROVAL STUDIES OR POSTMARKET
SURVEILLANCE DUE TO INSUFFICIENT DEMOGRAPHIC SUBGROUP
DATA.
(a) Drugs.--
(1) In general.--Section 505(o)(3)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(B)) is amended by
adding at the end the following:
``(iv) To provide safety and effectiveness
data for the drug involved for a demographic
subgroup or subgroups, if--
``(I) the clinical trials conducted
in support of the approval of the drug
did not meet the applicable targets of
enrollment, as described in section 2
of the DEPICT Act; and
``(II) in the judgment of the
Secretary, additional data could inform
drug labeling.''.
(2) Waiver.--Section 505(o)(3)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)(D)) is amended by
adding at the end the following:
``(iii) Clinical trial diversity
enrollment.--The Secretary may not require
postapproval studies or postapproval clinical
trials for the purpose specified under
subparagraph (B)(iv) if the sponsor provides to
the Secretary a sufficient justification for
not meeting the enrollment targets referred to
in such subparagraph, which may include--
``(I) factors outside of the
sponsor's control, such as a lack of
retention of participants;
``(II) differences in the
enrollment targets, disaggregated by
demographic subgroup, and actual
enrollment that are determined by the
Secretary to be insignificant in
nature;
``(III) information not available
to the sponsor at the time such
enrollment targets were chosen, but
that impacted enrollment of diverse
participants;
``(IV) potential for selection
bias; and
``(V) any other reason that the
Secretary determines is sufficient
justification.''.
(3) Use of real world evidence.--Section 505(o)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)) is
amended by adding at the end the following:
``(G) Use of real world evidence.--Real world
evidence (as defined in section 505F(b)) may be used to
support or satisfy the requirements under this
paragraph.''.
(b) Devices.--Section 522(a)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360l(a)(1)(A)) is amended--
(1) in subparagraph (A)--
(A) in clause (ii), by striking ``or'' at the end;
(B) in clause (iii)(II), by striking ``facility.''
and inserting ``facility; or''; and
(C) by adding at the end the following:
``(iv) with respect to which--
``(I) clinical studies submitted to
support that approval or clearance did
not meet the applicable targets of
enrollment, as described in section 2
of the DEPICT Act; and
``(II) with respect to which a
justification described in subparagraph
(D) is not provided.''; and
(2) by adding at the end the following:
``(C) Use of real world evidence.--Real world
evidence (as defined in section 505F(b)) may be used to
support or satisfy the requirements under this
paragraph.
``(D) Clinical trial diversity enrollment.--The
Secretary may not require a manufacturer to conduct
postmarket surveillance under subparagraph (A) with
respect to a device for the purpose specified in clause
(iv) of such subparagraph if the manufacturer provides
to the Secretary a sufficient justification for not
meeting the enrollment targets referred to in such
subparagraph, which may include--
``(i) factors outside of the manufacturer's
control, such as a lack of retention of
participants;
``(ii) differences in the enrollment
targets, disaggregated by demographic subgroup,
and actual enrollment that are determined by
the Secretary to be insignificant in nature;
``(iii) information not available to the
manufacturer at the time such enrollment
targets were chosen, but that impacted
enrollment of diverse participants;
``(iv) potential for selection bias; and
``(v) any other reason that the Secretary
determines is sufficient justification.''.
(c) Reports for Certain Devices.--The Commissioner of Food and
Drugs shall issue regulations revising section 814.84 of title 21, Code
of Federal Regulations, to require holders of an application approved
under section 515 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e) to include in the reports submitted under such section
814.84, to the extent possible, any data not previously submitted under
such section 814.84 that may inform the safety and effectiveness of the
device involved in underrepresented demographic subgroups.
(d) Registry and Results Data Bank Inclusion.--Section 402(j)(1)(A)
of the Public Health Service Act (282(j)(1)(A)) is amended--
(1) in clause (ii)--
(A) in subclause (I), by striking ``and'' at the
end;
(B) in subclause (II), by striking the period at
the end and inserting ``; and''; and
(C) by adding at the end the following:
``(III) postmarket surveillance for
any device as required under clause
(iv) of section 522(a)(1)(A) of the
Federal Food, Drug, and Cosmetic
Act.''; and
(2) in clause (iii)(I), by striking the period at the end
and inserting the following: ``, including any postapproval
study or postapproval clinical trial for a drug as required
under section 505(o)(3)(B)(iv) of the Federal Food, Drug, and
Cosmetic Act.''.
(e) Public Meeting.--
(1) In general.--Not later than 270 days after the date of
enactment of this Act, the Secretary, acting through the
Commissioner of Food and Drugs, and in consultation with drug
sponsors, medical device manufacturers, patients, and other
stakeholders, shall convene a public meeting to consider the
ways by which--
(A) drug sponsors and medical device manufacturers
may disseminate information to the public on clinical
trial enrollment demographic data in a timely and
accessible manner;
(B) drug and device sponsors, in consultation with
the Commissioner of Food and Drugs, may publicly
disseminate information on subgroup analyses conducted
by the sponsors in cases where--
(i) such data is not sufficient for the
purpose of updating drug and device labels; or
(ii) such analyses do not show significant
differences between demographic subgroups; and
(C) drug and device sponsors, in consultation with
the Commissioner of Food and Drugs, may collect and
publicly disseminate real world evidence that may
provide information on the safety and effectiveness of
drugs or devices for a demographic subgroup or
subgroups.
(2) Report.--Not later than 180 days after the date on
which the public meeting is convened under paragraph (1), the
Secretary shall make available on the website of the Food and
Drug Administration a report on the topics discussed at such
meeting. The report shall include a summary of, and response
to, recommendations raised in such meeting.
SEC. 4. ANNUAL REPORT ON PROGRESS TO INCREASE DIVERSITY IN CLINICAL
TRIALS AND STUDIES.
(a) In General.--Beginning not later than 2 years after the date of
the enactment of this Act, and each year thereafter, the Secretary of
Health and Human Services, acting through the Commissioner of Food and
Drugs, shall submit to Congress, and publish on the public website of
the Food and Drug Administration, a report that addresses progress on
increasing diversity in clinical trial and study enrollment.
(b) Contents of Report.--The report submitted under subsection (a)
shall include, with respect to applications for drugs or devices
approved or cleared under section 505, 510(k), or 515 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), or 360e) or
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262) during the calendar year that immediately precedes the year in
which the report is submitted--
(1) an analysis of the extent to which clinical trials
conducted with respect to such applications have met the
demographic subgroup enrollment targets for clinical trials and
studies required by the regulations amended pursuant to section
2 and the amendments made by section 3;
(2) the frequency with which enrollment targets by
demographic subgroup set for a clinical trial conducted under
an exemption for investigational use of a drug under section
505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(i)) or section 351 of the Public Health Service Act (42
U.S.C. 262) or an exemption for investigational use of a device
under section 520(g) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j(g)) do not adequately reflect the incidence
in the United States population of the disease or condition
being studied in the clinical trial and a summary of the
rationales provided for enrollment targets by demographic
subgroup in such cases;
(3) a summary of the justifications sponsors provided in
the cases where sponsors did not meet the enrollment targets
specified pursuant to section 2, disaggregated by demographic
subgroup; and
(4) the Secretary's recommendations, as appropriate, for
strategies presented in such diversity plans to attain
enrollment targets that should be adopted by sponsors as best
practices.
(c) Postmarket Studies.--Beginning 3 years after the first instance
in which the Secretary requires the sponsor of an application for a
drug or device approved or cleared under section 505, 510(k), or 515 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), or
360e) or licensed under section 351 of the Public Health Service Act
(42 U.S.C. 262) to conduct postmarket studies or postmarket
surveillance under clause (iv) of section 505(o)(3)(B) and clause (iv)
of section 522(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (as
added by subsections (a) and (b) of section 3), and each year
thereafter, the report submitted under subsection (a) shall also
include--
(1) the number of such applications that were required to
initiate postmarket studies or surveillance in the previous
calendar year under clause (iv) of section 505(o)(3)(B) and
clause (iv) of section 522(a)(1)(A) of the Federal Food, Drug,
and Cosmetic Act (as added by subsections (a) and (b) of
section 3), the numbers of such applications that have, as of
the end of the calendar year immediately preceding the year in
which the report is submitted, in-progress postmarket
requirements, and the number of such applications that have
completed postmarket requirements for each year, beginning on
the date of the enactment of this Act;
(2) an analysis of the average amount of time for
completion of such postmarket requirements, disaggregated by
type of application and type of postmarket requirement;
(3) an analysis of how the imposition of such postmarket
requirements has impacted the availability of demographic
subgroup-specific safety and efficacy data for drugs,
biologics, and devices; and
(4) the Secretary's recommendations, as appropriate, for
additional guidance or postmarket requirements to facilitate
the collection and reporting of representative demographic
subgroup data in support of applications for the approval or
clearance of, or updates to the labeling of, drugs and devices
under section 505, 510(k), or 515 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355, 360(k), or 360e) or licensure
of biological products under section 351 of the Public Health
Service Act (42 U.S.C. 262).
(d) Confidentiality.--Nothing in this section shall be construed as
authorizing the Secretary to disclose any information that is a trade
secret or confidential information subject to section 552(b)(4) of
title 5, United States Code, or section 1905 of title 18, United States
Code.
SEC. 5. PUBLIC MEETING ON CLINICAL TRIAL FLEXIBILITIES INITIATED IN
RESPONSE TO COVID-19 PANDEMIC.
(a) In General.--Not later than 180 days after the date on which
the COVID-19 emergency period ends, the Secretary of Health and Human
Services shall convene a public meeting to discuss the regulatory
flexibilities adopted by the Food and Drug Administration during the
COVID-19 emergency period to mitigate disruption of clinical studies
and clinical trials, including flexibilities detailed in the March 2020
guidance entitled ``Conduct of Clinical Trials of Medical Products
During the COVID-19 Public Health Emergency, Guidance for Industry,
Investigators, and Institutional Review Boards'', and any subsequent
updates to such guidance. The Secretary shall invite to such meeting
representatives from the pharmaceutical and medical device industries
who sponsored clinical trials and clinical studies during the COVID-19
emergency period and organizations representing patients.
(b) Topics.--Not later than 90 days after the date on which the
public meeting under subsection (a) is convened, the Secretary shall
make available on the public website of the Food and Drug
Administration a report on the topics discussed at such meeting. Such
topics shall include discussion of--
(1) the actions drug sponsors took to utilize such
regulatory flexibilities and the frequency at which such
flexibilities were employed;
(2) the characteristics of the sponsors, trials, and
patient populations impacted by such regulatory flexibilities;
(3) a consideration of how regulatory flexibilities to
mitigate disruption of clinical trials during the COVID-19
emergency period, including decentralized clinical trials, may
have affected access to clinical studies and trials for certain
patient populations, especially unrepresented racial and ethnic
minorities; and
(4) recommendations for incorporating certain clinical
trial disruption mitigation flexibilities into current or
additional guidance to improve clinical trial access and
enrollment of diverse patient populations.
(c) COVID-19 Emergency Period Defined.--In this section, the term
``COVID-19 emergency period'' has the meaning given the term
``emergency period'' in section 1135(g)(1)(B) of the Social Security
Act (42 U.S.C. 1320b-5(g)(1)(B)).
SEC. 6. COMMUNITY ENGAGEMENT AND OUTREACH TO IMPROVE INCLUSION OF
UNDERREPRESENTED MINORITIES IN CLINICAL TRIALS AND
RESEARCH.
(a) In General.--The Secretary of Health and Human Services, acting
through the Director of the National Institutes of Health, shall
conduct, coordinate, and support activities for purposes of community
engagement with, and outreach to, underserved communities to facilitate
inclusion of underrepresented minorities in clinical research and
clinical trials.
(b) Activities.--Activities conducted, coordinated, or supported
under this section may be for any of the following purposes:
(1) Developing and disseminating best practices for
community engagement and outreach and for inclusive
participation in clinical research and trials.
(2) Creating and providing tools and educational
resources--
(A) to facilitate adoption of such best practices
by researchers and clinical trial sponsors; and
(B) to encourage awareness of, and participation
in, clinical trials and research among underrepresented
minorities.
(3) Engaging community stakeholders in underrepresented
racial and ethnic minority communities and fostering
partnerships with community-based organizations serving
underrepresented racial and ethnical minority populations to
encourage participation in clinical trials and research.
(4) Conducting and supporting community engagement
research.
(c) Supplement, Not Supplant.--Grants under this subsection shall
be used to supplement and not supplant existing initiatives and
programs at the National Institutes of Health to improve diversity in
clinical trials and research.
SEC. 7. GRANTS TO INCREASE THE CAPACITY OF COMMUNITY HEALTH CENTERS TO
PARTICIPATE IN CLINICAL TRIALS AND RESEARCH.
(a) In General.--The Secretary of Health and Human Services, acting
through the Administrator of the Health Resources and Services
Administration and in consultation with the Director of the National
Institutes of Health, shall award grants to, and enter into cooperative
agreements with, qualified entities to increase capacity at such
qualified entities to participate in clinical trials and research by--
(1) enhancing and expanding infrastructure at community
health centers to support participation in clinical trials and
research, including information technology improvements and the
hiring and training of healthcare personnel, such as patient
navigators and culturally trained site personnel to conduct, or
recruit for, clinical trials;
(2) reimbursing administrative costs and patient care costs
incurred by qualified entities in the course of clinical
research and trials that are not otherwise reimbursable by
existing payers; and
(3) implementing community education and outreach
strategies.
(b) Qualified Entities Defined.--In this section, the term
``qualified entity'' means--
(1) rural health clinics, as defined in section 1861(aa)(2)
of the Social Security Act (42 U.S.C. 1395x(aa)(2));
(2) federally-qualified health centers described in section
1861(aa)(4)(B) of the Social Security Act (42 U.S.C.
1395x(aa)(4)(B));
(3) facilities operated by the Indian Health Service, an
Indian Tribe, Tribal Organization, or an Urban Indian
organization, as those terms are defined in section 4 of the
Indian Health Care Improvement Act (25 U.S.C. 1603); and
(4) entities eligible to receive funds under section 330 of
the Public Health Service Act (42 U.S.C. 254b).
SEC. 8. AUTHORIZATION OF APPROPRIATIONS.
There is authorized to be appropriated to carry out this Act,
$100,000,000 for the period of fiscal years 2022 through 2025.
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