Advancing Safe Medications for Moms and Babies Act of 2023
This bill establishes programs and requirements to support the inclusion of pregnant and lactating women in clinical research.
For example, the bill requires the Department of Health and Human Services to align the Food and Drug Administration's regulations for human subjects in clinical trials with other departmental regulations for pregnant women in clinical research.
The bill also establishes (1) a national online clearinghouse with information about clinical trials that enroll pregnant and lactating women, (2) an advisory committee to help coordinate federal activities with respect to clinical research for pregnant and lactating women, and (3) an educational campaign on the importance of including pregnant and lactating women in clinical research.
The National Institutes of Health must also prioritize certain research projects on new and existing medications for pregnant and lactating women based on need, feasibility, and the potential impact of the research.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1117 Introduced in House (IH)]
<DOC>
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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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