Advancing Safe Medications for Moms and Babies Act of 2023



<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1117 Introduced in House (IH)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                H. R. 1117

   To implement certain recommendations to promote the inclusion of 
   pregnant and lactating women in clinical research, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 21, 2023

Ms. Castor of Florida (for herself, Mr. Fitzpatrick, and Ms. Underwood) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To implement certain recommendations to promote the inclusion of 
   pregnant and lactating women in clinical research, 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 ``Advancing Safe Medications for Moms 
and Babies Act of 2023''.

SEC. 2. UPDATING FDA REGULATIONS TO REMOVE PREGNANT WOMEN AS A 
              VULNERABLE RESEARCH POPULATION.

    (a) Purposes.--The purposes of this section are--
            (1) to facilitate compliance with applicable Federal 
        regulations relating to the protection of pregnant women 
        participating in research as subjects; and
            (2) to promote the inclusion of pregnant women in clinical 
        research.
    (b) Harmonization.--For the purposes specified in subsection (a), 
the Secretary of Health and Human Services (in this Act referred to as 
the ``Secretary'') shall, to the extent practicable and consistent with 
other applicable statutes, issue such regulations as may be appropriate 
to harmonize the regulations of the Food and Drug Administration 
relating to the protection of human subjects, including parts 50 and 56 
of title 21, Code of Federal Regulations, with the latest regulations 
of the Department of Health and Human Services relating to the 
inclusion of pregnant women as subjects in clinical research.
    (c) Deadline.--The Secretary of Health and Human Services shall 
finalize the regulations required by subsection (b) not later than 180 
days after the date of enactment of this Act.

SEC. 3. CLEARINGHOUSE OF CLINICAL TRIALS AND REGISTRIES.

    (a) In General.--The Secretary, acting through the Director of the 
National Institutes of Health, and in consultation with the 
Commissioner of Food and Drugs and the heads of other relevant Federal 
departments and agencies, shall establish and maintain a national 
clearinghouse of educational materials and current information on 
registries and clinical trials that enroll pregnant and lactating women 
in order to--
            (1) enable pregnant and lactating women, their families, 
        and health care professionals to easily identify and enroll in 
        registries and clinical trials;
            (2) educate pregnant and lactating women, their families, 
        and health care professionals on the importance of enrolling in 
        registries and clinical trials; and
            (3) inform pregnant and lactating women, their families, 
        and health care professionals about the general requirements, 
        commitments, and benefits associated with participating in a 
        registry or clinical trial.
    (b) Requirements.--The Secretary, acting through the Director of 
the National Institutes of Health, and in consultation with the 
Commissioner of Food and Drugs and the heads of other relevant Federal 
departments and agencies, shall ensure that the clearinghouse under 
subsection (a)--
            (1) is accessible by means of the internet;
            (2) is updated on a regular basis, not less than quarterly;
            (3) is designed for consumers, incorporates a user-friendly 
        interface, and is searchable;
            (4) includes links to related public and private sector 
        resources on registries and clinical trials described in 
        subsection (a); and
            (5) is available to the public by October 1, 2025.
    (c) Planning.--
            (1) In general.--In establishing the clearinghouse under 
        subsection (a), the Secretary, shall--
                    (A) develop criteria for which registries and 
                clinical trials are eligible for listing in the 
                clearinghouse under subsection (a);
                    (B) establish a procedure for archiving closed 
                registries and clinical trials; and
                    (C) identify educational resources needed for the 
                clearinghouse.
            (2) Public input.--The Secretary shall solicit public input 
        on content to be included in the clearinghouse under subsection 
        (a).
    (d) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated--
            (1) $4,000,000 for the period of fiscal years 2024 through 
        2025; and
            (2) $3,000,000 for the period of fiscal years 2026 through 
        2028.

SEC. 4. COORDINATING COMMITTEE ON RESEARCH SPECIFIC TO PREGNANT AND 
              LACTATING WOMEN.

    (a) Establishment.--Not later than 90 days after the date of 
enactment of this Act, the Secretary shall establish a committee, in 
accordance with the Federal Advisory Committee Act (5 U.S.C. App.), to 
be known as the Committee on Research Specific to Pregnant and 
Lactating Women or the PRGLAC Committee (in this section referred to as 
the ``Committee'') to advise on coordinating Federal activities to 
address gaps in knowledge and research regarding safe and effective 
therapies for pregnant and lactating women.
    (b) Duties.--The Committee shall--
            (1) advise on coordinating Federal activities to promote 
        the inclusion of pregnant and lactating women in clinical 
        research;
            (2) promote opportunities for Federal agencies and private 
        actors to advance the inclusion of pregnant and lactating women 
        in clinical research;
            (3) develop and annually update a summary of Federal agency 
        progress toward implementing recommendations included in the 
        September 2018 Report to the Secretary of Health and Human 
        Services, and the August 2020 Report Implementation Plan to the 
        Secretary of Health and Human Services, prepared by the Task 
        Force on Research Specific to Pregnant Women and Lactating 
        Women;
            (4) identify new recommendations for the Secretary 
        regarding Federal activities to address gaps in knowledge and 
        research regarding safe and effective therapies for pregnant 
        and lactating women; and
            (5) receive updates on private sector and international 
        efforts to include pregnant and lactating women in clinical 
        research.
    (c) Membership.--
            (1) In general.--The Committee shall be composed of--
                    (A) the Federal members listed in paragraph (2); 
                and
                    (B) the non-Federal members appointed pursuant to 
                paragraph (3).
            (2) Federal members.--The Federal members of the Committee 
        shall consist of the following Federal officials (or their 
        designees):
                    (A) The Director of the Centers for Disease Control 
                and Prevention.
                    (B) The Director of the National Institutes of 
                Health, the Director of the Eunice Kennedy Shriver 
                National Institute of Child Health and Human 
                Development, the Director of the Office of Research on 
                Women's Health of the National Institutes of Health, 
                and the directors of such other national research 
                institutes and national centers of the National 
                Institutes of Health as the Secretary determines 
                appropriate.
                    (C) The Commissioner of Food and Drugs.
                    (D) The Director of the Agency for Healthcare 
                Research and Quality.
                    (E) The Director of the Office on Women's Health of 
                the Department of Health and Human Services.
                    (F) The Director of the National Vaccine Program.
                    (G) The Director of the Office for Human Research 
                Protections of the Department of Health and Human 
                Services.
                    (H) The Administrator of Health Resources and 
                Services Administration.
                    (I) The head of any other research-related agency 
                or department not described in subparagraphs (A) 
                through (H) as the Secretary determines appropriate, 
                which may include the Department of Veterans Affairs 
                and the Department of Defense.
            (3) Non-federal members.--
                    (A) In general.--The non-Federal members of the 
                Committee shall consist of--
                            (i) representatives from relevant medical 
                        societies with subject matter expertise on 
                        pregnant women, lactating women, or children;
                            (ii) representatives from nonprofit 
                        organizations with expertise related to the 
                        health of women and children;
                            (iii) relevant industry representatives;
                            (iv) individuals with ethical and legal 
                        expertise in clinical trials and research;
                            (v) representatives from relevant nonprofit 
                        organizations with expertise in clinical 
                        research; and
                            (vi) other representatives, as the 
                        Secretary determines appropriate.
                    (B) Limitations.--The non-Federal members of the 
                Committee shall compose not more than one-half, and not 
                less than one-third, of the total membership of the 
                Committee.
                    (C) Appointment.--The Secretary shall appoint the 
                non-Federal members of the Committee.
                    (D) Terms.--The non-Federal members of the 
                Committee shall serve for a term of 4 years, and may be 
                reappointed for 1 additional 4-year term. Any non-
                Federal member appointed to fill a vacancy for an 
                unexpired term shall be appointed for the remainder of 
                such term. A non-Federal member may serve after the 
                expiration of the member's term until a successor has 
                taken office.
    (d) Administrative Support.--The Secretary shall provide the 
Committee such administrative support as the Secretary determines to be 
necessary for carrying out this section.
    (e) Meetings.--The Committee shall meet at least 2 times each year 
and shall convene public meetings, as appropriate, to fulfill its 
duties under subsection (b).
    (f) Report to Congress.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, and every other year thereafter, the 
        Committee shall prepare and submit to the Secretary, the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate, and the Committee on Energy and Commerce of the House 
        of Representatives a report on--
                    (A) the progress of Federal agencies in 
                implementing the recommendations and implementation 
                plan described in subsection (b)(3);
                    (B) Federal activities undertaken to advance the 
                inclusion of pregnant and lactating women in clinical 
                research; and
                    (C) additional recommendations for the Secretary 
                regarding Federal activities to address gaps in 
                knowledge and research regarding safe and effective 
                therapies for pregnant and lactating women.
            (2) Public availability.--The Secretary shall make the 
        reports required by paragraph (1) available on a public website 
        of the Department of Health and Human Services.
    (g) Supplemental Report on Department Guidance.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Committee shall prepare and submit 
        to the Secretary, the Committee on Health, Education, Labor, 
        and Pensions of the Senate, and the Committee on Energy and 
        Commerce of the House of Representatives a report to inform 
        guidance of the Department of Health and Human Services to 
        facilitate the conduct of clinical research involving pregnant 
        and lactating women.
            (2) Contents.--The report under paragraph (1) shall 
        include--
                    (A) information on which clinical studies require 
                consent from both biological parents, including 
                information quantifying how requiring consent from both 
                biological parents limits participation in such 
                clinical studies;
                    (B) best practices and recommendations for 
                institutional review boards related to the inclusion of 
                pregnant and lactating women in clinical research, 
                including information on successes and challenges of 
                using a centralized institutional review board; and
                    (C) an evaluation of statutory programs enacted to 
                spur pediatric-specific information in Food and Drug 
                Administration-approved therapies, such as the Best 
                Pharmaceuticals for Children Act (Public Law 107-109) 
                and the Pediatric Research Equity Act of 2008 (Public 
                Law 108-155), and how approaches taken in such programs 
                can be applied to clinical research including pregnant 
                and lactating women.
            (3) Public availability.--The Secretary shall make the 
        report required by paragraph (1) available on a public website 
        of the Department of Health and Human Services.
    (h) Termination.--
            (1) In general.--The Committee shall terminate on the date 
        that is 5 years after the date on which the Committee is 
        established under subsection (a).
            (2) Extension.--The Secretary may extend the operation of 
        the Committee for up to 3 additional 2-year periods following 
        the 5-year period described in paragraph (1) if the Secretary 
        determines that the extension is appropriate to monitor the 
        implementation of the recommendations and implementation plan 
        described in subsection (b)(3) or any additional 
        recommendations made by the Committee.

SEC. 5. RAISING AWARENESS OF RESEARCH THAT INCLUDES PREGNANT AND 
              LACTATING WOMEN IN CLINICAL RESEARCH.

    (a) In General.--The Secretary, acting through the Director of the 
National Institutes of Health, in consultation with the heads of other 
relevant Federal agencies, shall establish and implement an education 
campaign designed to--
            (1) educate the public on the importance of--
                    (A) including pregnant and lactating women in 
                clinical research to better inform health care 
                decisions on the safety and effectiveness of 
                medications for pregnant and lactating women before, 
                during, and after pregnancy;
                    (B) registries and clinical trials that include 
                pregnant and lactating women;
            (2) encourage and facilitate participation by pregnant and 
        lactating women in clinical research;
            (3) improve the general understanding of the critical role 
        registries and other postmarket surveillance activities have in 
        collecting data related to the use of medications by pregnant 
        and lactating women;
            (4) improve the understanding of available clinical trials 
        and registries that enroll pregnant and lactating women;
            (5) encourage pregnant and lactating women to seek 
        additional information about such opportunities to participate 
        in clinical research;
            (6) encourage health care providers to make information on 
        clinical research available to pregnant and lactating women; 
        and
            (7) facilitate access to and enrollment in such research by 
        pregnant and lactating women.
    (b) Consultation.--In carrying out this section, the Secretary 
shall consult with--
            (1) nonprofit organizations with expertise related to the 
        health of women and children, including those representing 
        populations with high rates of maternal mortality and 
        morbidity;
            (2) representatives from relevant medical societies with 
        subject matter expertise on pregnant women, lactating women, or 
        children;
            (3) relevant industry representatives; and
            (4) other representatives, as appropriate.
    (c) Planning.--In establishing the campaign under subsection (a), 
the Secretary, acting through the Director of the National Institutes 
of Health, in consultation with the heads of other relevant Federal 
agencies, shall--
            (1) conduct a needs assessment to--
                    (A) evaluate existing resources; and
                    (B) identify barriers to awareness and 
                opportunities to fill gaps and address barriers;
            (2) identify target audiences for the campaign;
            (3) identify best practices to reach each such target 
        audience;
            (4) test appropriate messaging strategies, including risk 
        communication messaging, for each target audience; and
            (5) coordinate with the clearinghouse established under 
        section 3.
    (d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $5,000,000 for the period of 
fiscal years 2024 through 2028.

SEC. 6. RESEARCH PRIORITIZATION PROCESS FOR PREGNANT AND LACTATING 
              WOMEN AT THE EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF 
              CHILD HEALTH AND HUMAN DEVELOPMENT.

    (a) In General.--The Director of the National Institutes of Health, 
acting through the Director of the Eunice Kennedy Shriver National 
Institute of Child Health and Human Development (referred to in this 
section as ``NICHD''), shall carry out priority research projects on 
existing and new medications prescribed for pregnant and lactating 
women.
    (b) Research Prioritization Process.--The Director of the National 
Institutes of Health shall establish a research prioritization process 
to determine which proposed research projects should receive priority 
funding under this section. Such research prioritization process shall 
take into account the following factors:
            (1) The available evidence, including whether there is an 
        unmet medical need or gap in scientific information relevant to 
        treatment of pregnant and lactating women with specific 
        diseases or conditions.
            (2) The feasibility of research, including the prevalence 
        of a disease or condition in pregnant and lactating women and 
        the availability of investigators with expertise in studying 
        such disease or condition.
            (3) The potential impact of research, including the 
        severity of the disease or condition in pregnant and lactating 
        women, the current cost of treating the disease or condition in 
        pregnant and lactating women, the frequency of use of the drug 
        in pregnant and lactating women, and the availability of 
        alternative treatments for the disease or condition in pregnant 
        and lactating women.
    (c) Consultation.--In developing the research prioritization 
process described in subsection (b), the Director of the National 
Institutes of Health shall seek feedback from--
            (1) the existing research networks of the National 
        Institute of Child Health and Human Development with expertise 
        in clinical research involving pregnant and lactating women;
            (2) relevant medical societies with subject matter 
        expertise on pregnant women, lactating women, or children; and
            (3) nonprofit organizations with expertise related to the 
        health of pregnant women, lactating women, or children, 
        including those representing populations with high rates of 
        maternal mortality and morbidity.
    (d) Public Comment.--The Secretary shall provide an opportunity for 
public comment on the program under this section.
    (e) Accountability and Oversight.--
            (1) Work plan.--Not later than 180 days after the date of 
        enactment of this Act, the Director of the National Institutes 
        of Health shall submit to the Committee on Health, Education, 
        Labor, and Pensions and the Committee on Appropriations of the 
        Senate and the Committee on Energy and Commerce and the 
        Committee on Appropriations of the House of Representatives a 
        work plan for--
                    (A) funding priority research projects under 
                subsection (a); and
                    (B) developing the research prioritization process 
                under subsection (b).
            (2) Reports.--Not later than October 1 of each of fiscal 
        years 2024 through 2028, the Director of the National 
        Institutes of Health shall submit to the Committee on Health, 
        Education, Labor, and Pensions and the Committee on 
        Appropriations of the Senate and the Committee on Energy and 
        Commerce and the Committee on Appropriations of the House of 
        Representatives a report on the program under this section, 
        including--
                    (A) the amount of money obligated or expended in 
                the prior fiscal year for each priority research 
                project under subsection (a);
                    (B) a description of each such project; and
                    (C) the rationale for prioritizing each such 
                project according to the process under subsection (b).
    (f) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $50,000,000 for the period of 
fiscals year 2024 through 2028.
                                 &lt;all&gt;
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