I 
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 En-
ergy and Commerce 
A BILL 
To implement certain recommendations to promote the inclu-
sion of pregnant and lactating women in clinical re-
search, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Advancing Safe Medi-
cations for Moms and Babies Act of 2023’’. 
SEC. 2. UPDATING FDA REGULATIONS TO REMOVE PREG-
NANT WOMEN AS A VULNERABLE RESEARCH 
POPULATION. 
(a) PURPOSES.—The purposes of this section are— 
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(1) to facilitate compliance with applicable Fed-
eral regulations relating to the protection of preg-
nant 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 Serv-
ices (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 Adminis-
tration relating to the protection of human subjects, in-
cluding parts 50 and 56 of title 21, Code of Federal Regu-
lations, 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 REG-
ISTRIES. 
(a) IN GENERAL.—The Secretary, acting through the 
Director of the National Institutes of Health, and in con-
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sultation with the Commissioner of Food and Drugs and 
the heads of other relevant Federal departments and agen-
cies, shall establish and maintain a national clearinghouse 
of educational materials and current information on reg-
istries 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 iden-
tify 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 as-
sociated 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 sub-
section (a)— 
(1) is accessible by means of the internet; 
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(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 de-
scribed in subsection (a); and 
(5) is available to the public by October 1, 
2025. 
(c) PLANNING.— 
(1) IN GENERAL.—In establishing the clearing-
house 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 clear-
inghouse under subsection (a). 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated— 
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(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 SPE-
CIFIC 
TO 
PREGNANT 
AND 
LACTATING 
WOMEN. 
(a) ESTABLISHMENT.—Not later than 90 days after 
the date of enactment of this Act, the Secretary shall es-
tablish a committee, in accordance with the Federal Advi-
sory Committee Act (5 U.S.C. App.), to be known as the 
Committee on Research Specific to Pregnant and Lac-
tating 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 re-
search 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 preg-
nant and lactating women in clinical research; 
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(3) develop and annually update a summary of 
Federal agency progress toward implementing rec-
ommendations included in the September 2018 Re-
port to the Secretary of Health and Human Serv-
ices, and the August 2020 Report Implementation 
Plan to the Secretary of Health and Human Serv-
ices, prepared by the Task Force on Research Spe-
cific to Pregnant Women and Lactating Women; 
(4) identify new recommendations for the Sec-
retary regarding Federal activities to address gaps 
in knowledge and research regarding safe and effec-
tive therapies for pregnant and lactating women; 
and 
(5) receive updates on private sector and inter-
national 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 para-
graph (2); and 
(B) the non-Federal members appointed 
pursuant to paragraph (3). 
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(2) FEDERAL MEMBERS.—The Federal mem-
bers of the Committee shall consist of the following 
Federal officials (or their designees): 
(A) The Director of the Centers for Dis-
ease 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. 
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(H) The Administrator of Health Re-
sources and Services Administration. 
(I) The head of any other research-related 
agency or department not described in subpara-
graphs (A) through (H) as the Secretary deter-
mines appropriate, which may include the De-
partment of Veterans Affairs and the Depart-
ment of Defense. 
(3) NON-FEDERAL MEMBERS.— 
(A) IN GENERAL.—The non-Federal mem-
bers of the Committee shall consist of— 
(i) representatives from relevant med-
ical societies with subject matter expertise 
on pregnant women, lactating women, or 
children; 
(ii) representatives from nonprofit or-
ganizations 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 non-
profit organizations with expertise in clin-
ical research; and 
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(vi) other representatives, as the Sec-
retary determines appropriate. 
(B) LIMITATIONS.—The non-Federal mem-
bers 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 Com-
mittee. 
(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 ap-
pointed 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). 
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(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 im-
plementing the recommendations and imple-
mentation plan described in subsection (b)(3); 
(B) Federal activities undertaken to ad-
vance the inclusion of pregnant and lactating 
women in clinical research; and 
(C) additional recommendations for the 
Secretary regarding Federal activities to ad-
dress 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.— 
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(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 Com-
mittee 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, in-
cluding information quantifying how requiring 
consent from both biological parents limits par-
ticipation in such clinical studies; 
(B) best practices and recommendations 
for institutional review boards related to the in-
clusion of pregnant and lactating women in 
clinical research, including information on suc-
cesses and challenges of using a centralized in-
stitutional review board; and 
(C) an evaluation of statutory programs 
enacted to spur pediatric-specific information in 
Food and Drug Administration-approved thera-
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pies, such as the Best Pharmaceuticals for Chil-
dren Act (Public Law 107–109) and the Pedi-
atric Research Equity Act of 2008 (Public Law 
108–155), and how approaches taken in such 
programs can be applied to clinical research in-
cluding 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 termi-
nate 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 addi-
tional 2-year periods following the 5-year period de-
scribed in paragraph (1) if the Secretary determines 
that the extension is appropriate to monitor the im-
plementation of the recommendations and implemen-
tation plan described in subsection (b)(3) or any ad-
ditional recommendations made by the Committee. 
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SEC. 5. RAISING AWARENESS OF RESEARCH THAT IN-
CLUDES PREGNANT AND LACTATING WOMEN 
IN CLINICAL RESEARCH. 
(a) IN GENERAL.—The Secretary, acting through the 
Director of the National Institutes of Health, in consulta-
tion with the heads of other relevant Federal agencies, 
shall establish and implement an education campaign de-
signed 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 effec-
tiveness of medications for pregnant and lac-
tating women before, during, and after preg-
nancy; 
(B) registries and clinical trials that in-
clude 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 surveil-
lance activities have in collecting data related to the 
use of medications by pregnant and lactating 
women; 
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(4) improve the understanding of available clin-
ical 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 in-
formation 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 re-
lated to the health of women and children, including 
those representing populations with high rates of 
maternal mortality and morbidity; 
(2) representatives from relevant medical soci-
eties 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 
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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 op-
portunities 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, in-
cluding risk communication messaging, for each tar-
get audience; and 
(5) coordinate with the clearinghouse estab-
lished 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 PREG-
NANT AND LACTATING WOMEN AT THE EU-
NICE KENNEDY SHRIVER NATIONAL INSTI-
TUTE OF CHILD HEALTH AND HUMAN DEVEL-
OPMENT. 
(a) IN GENERAL.—The Director of the National In-
stitutes of Health, acting through the Director of the Eu-
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nice 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 Di-
rector of the National Institutes of Health shall establish 
a research prioritization process to determine which pro-
posed 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 alter-
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native treatments for the disease or condition in 
pregnant and lactating women. 
(c) CONSULTATION.—In developing the research 
prioritization process described in subsection (b), the Di-
rector of the National Institutes of Health shall seek feed-
back from— 
(1) the existing research networks of the Na-
tional Institute of Child Health and Human Devel-
opment with expertise in clinical research involving 
pregnant and lactating women; 
(2) relevant medical societies with subject mat-
ter expertise on pregnant women, lactating women, 
or children; and 
(3) nonprofit organizations with expertise re-
lated 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 
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the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of 
the Senate and the Committee on Energy and Com-
merce 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 Com-
merce 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 ex-
pended 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 sub-
section (b). 
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(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. 
Æ 
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