[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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