What This Bill Does
This bill aims to include more pregnant and lactating women in medical research studies. It requires the federal government to update rules for medical research, create a public website listing available research studies, establish a coordinating committee to oversee progress, and fund education campaigns about research opportunities.
Who It Affects
Pregnant women, lactating women (women who are breastfeeding), health care providers, medical research organizations, pharmaceutical companies, federal health agencies, institutional review boards (groups that approve research studies), and the general public seeking information about medical research.
Key Provisions
• The Food and Drug Administration must update its regulations within 180 days to align with the latest rules about including pregnant women in research (Sec. 2)
• A public website must be created and launched by October 1, 2025 to help pregnant and lactating women find and enroll in research studies and registries (Sec. 3)
• A new federal committee must be established within 90 days to coordinate government efforts and recommend ways to improve research involving pregnant and lactating women (Sec. 4)
• The government must run an education campaign to teach the public and doctors about research opportunities for pregnant and lactating women (Sec. 5)
• The National Institutes of Health must fund priority research projects on medications used by pregnant and lactating women (Sec. 6)
What Changes
If this becomes law, pregnant and lactating women will have easier access to information about medical research they can join. Federal agencies will work together more closely on this issue. There will be more government-funded research specifically studying medications for pregnant and lactating women. The government will invest in educating women and doctors about these research opportunities.
Important Definitions
Clinical research: Medical studies testing whether treatments are safe and effective
Lactating women: Women who are breastfeeding
Registries: Systems that collect and track health information about groups of people with certain conditions
Postmarket surveillance: Monitoring of medications after they are approved and sold to the public
Effective Date
Not specified in bill text
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-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Advancing Safe Medi-
4
cations for Moms and Babies Act of 2023’’.
5
SEC. 2. UPDATING FDA REGULATIONS TO REMOVE PREG-
6
NANT WOMEN AS A VULNERABLE RESEARCH
7
POPULATION.
8
(a) PURPOSES.—The purposes of this section are—
9
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•HR 1117 IH
(1) to facilitate compliance with applicable Fed-
1
eral regulations relating to the protection of preg-
2
nant women participating in research as subjects;
3
and
4
(2) to promote the inclusion of pregnant women
5
in clinical research.
6
(b) HARMONIZATION.—For the purposes specified in
7
subsection (a), the Secretary of Health and Human Serv-
8
ices (in this Act referred to as the ‘‘Secretary’’) shall, to
9
the extent practicable and consistent with other applicable
10
statutes, issue such regulations as may be appropriate to
11
harmonize the regulations of the Food and Drug Adminis-
12
tration relating to the protection of human subjects, in-
13
cluding parts 50 and 56 of title 21, Code of Federal Regu-
14
lations, with the latest regulations of the Department of
15
Health and Human Services relating to the inclusion of
16
pregnant women as subjects in clinical research.
17
(c) DEADLINE.—The Secretary of Health and
18
Human Services shall finalize the regulations required by
19
subsection (b) not later than 180 days after the date of
20
enactment of this Act.
21
SEC. 3. CLEARINGHOUSE OF CLINICAL TRIALS AND REG-
22
ISTRIES.
23
(a) IN GENERAL.—The Secretary, acting through the
24
Director of the National Institutes of Health, and in con-
25
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•HR 1117 IH
sultation with the Commissioner of Food and Drugs and
1
the heads of other relevant Federal departments and agen-
2
cies, shall establish and maintain a national clearinghouse
3
of educational materials and current information on reg-
4
istries and clinical trials that enroll pregnant and lactating
5
women in order to—
6
(1) enable pregnant and lactating women, their
7
families, and health care professionals to easily iden-
8
tify and enroll in registries and clinical trials;
9
(2) educate pregnant and lactating women,
10
their families, and health care professionals on the
11
importance of enrolling in registries and clinical
12
trials; and
13
(3) inform pregnant and lactating women, their
14
families, and health care professionals about the
15
general requirements, commitments, and benefits as-
16
sociated with participating in a registry or clinical
17
trial.
18
(b) REQUIREMENTS.—The Secretary, acting through
19
the Director of the National Institutes of Health, and in
20
consultation with the Commissioner of Food and Drugs
21
and the heads of other relevant Federal departments and
22
agencies, shall ensure that the clearinghouse under sub-
23
section (a)—
24
(1) is accessible by means of the internet;
25
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(2) is updated on a regular basis, not less than
1
quarterly;
2
(3) is designed for consumers, incorporates a
3
user-friendly interface, and is searchable;
4
(4) includes links to related public and private
5
sector resources on registries and clinical trials de-
6
scribed in subsection (a); and
7
(5) is available to the public by October 1,
8
2025.
9
(c) PLANNING.—
10
(1) IN GENERAL.—In establishing the clearing-
11
house under subsection (a), the Secretary, shall—
12
(A) develop criteria for which registries
13
and clinical trials are eligible for listing in the
14
clearinghouse under subsection (a);
15
(B) establish a procedure for archiving
16
closed registries and clinical trials; and
17
(C) identify educational resources needed
18
for the clearinghouse.
19
(2) PUBLIC INPUT.—The Secretary shall solicit
20
public input on content to be included in the clear-
21
inghouse under subsection (a).
22
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry
23
out this section, there are authorized to be appropriated—
24
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(1) $4,000,000 for the period of fiscal years
1
2024 through 2025; and
2
(2) $3,000,000 for the period of fiscal years
3
2026 through 2028.
4
SEC. 4. COORDINATING COMMITTEE ON RESEARCH SPE-
5
CIFIC
TO
PREGNANT
AND
LACTATING
6
WOMEN.
7
(a) ESTABLISHMENT.—Not later than 90 days after
8
the date of enactment of this Act, the Secretary shall es-
9
tablish a committee, in accordance with the Federal Advi-
10
sory Committee Act (5 U.S.C. App.), to be known as the
11
Committee on Research Specific to Pregnant and Lac-
12
tating Women or the PRGLAC Committee (in this section
13
referred to as the ‘‘Committee’’) to advise on coordinating
14
Federal activities to address gaps in knowledge and re-
15
search regarding safe and effective therapies for pregnant
16
and lactating women.
17
(b) DUTIES.—The Committee shall—
18
(1) advise on coordinating Federal activities to
19
promote the inclusion of pregnant and lactating
20
women in clinical research;
21
(2) promote opportunities for Federal agencies
22
and private actors to advance the inclusion of preg-
23
nant and lactating women in clinical research;
24
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•HR 1117 IH
(3) develop and annually update a summary of
1
Federal agency progress toward implementing rec-
2
ommendations included in the September 2018 Re-
3
port to the Secretary of Health and Human Serv-
4
ices, and the August 2020 Report Implementation
5
Plan to the Secretary of Health and Human Serv-
6
ices, prepared by the Task Force on Research Spe-
7
cific to Pregnant Women and Lactating Women;
8
(4) identify new recommendations for the Sec-
9
retary regarding Federal activities to address gaps
10
in knowledge and research regarding safe and effec-
11
tive therapies for pregnant and lactating women;
12
and
13
(5) receive updates on private sector and inter-
14
national efforts to include pregnant and lactating
15
women in clinical research.
16
(c) MEMBERSHIP.—
17
(1) IN
GENERAL.—The Committee shall be
18
composed of—
19
(A) the Federal members listed in para-
20
graph (2); and
21
(B) the non-Federal members appointed
22
pursuant to paragraph (3).
23
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•HR 1117 IH
(2) FEDERAL MEMBERS.—The Federal mem-
1
bers of the Committee shall consist of the following
2
Federal officials (or their designees):
3
(A) The Director of the Centers for Dis-
4
ease Control and Prevention.
5
(B) The Director of the National Institutes
6
of Health, the Director of the Eunice Kennedy
7
Shriver National Institute of Child Health and
8
Human Development, the Director of the Office
9
of Research on Women’s Health of the National
10
Institutes of Health, and the directors of such
11
other national research institutes and national
12
centers of the National Institutes of Health as
13
the Secretary determines appropriate.
14
(C) The Commissioner of Food and Drugs.
15
(D) The Director of the Agency for
16
Healthcare Research and Quality.
17
(E) The Director of the Office on Women’s
18
Health of the Department of Health and
19
Human Services.
20
(F) The Director of the National Vaccine
21
Program.
22
(G) The Director of the Office for Human
23
Research Protections of the Department of
24
Health and Human Services.
25
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(H) The Administrator of Health Re-
1
sources and Services Administration.
2
(I) The head of any other research-related
3
agency or department not described in subpara-
4
graphs (A) through (H) as the Secretary deter-
5
mines appropriate, which may include the De-
6
partment of Veterans Affairs and the Depart-
7
ment of Defense.
8
(3) NON-FEDERAL MEMBERS.—
9
(A) IN GENERAL.—The non-Federal mem-
10
bers of the Committee shall consist of—
11
(i) representatives from relevant med-
12
ical societies with subject matter expertise
13
on pregnant women, lactating women, or
14
children;
15
(ii) representatives from nonprofit or-
16
ganizations with expertise related to the
17
health of women and children;
18
(iii) relevant industry representatives;
19
(iv) individuals with ethical and legal
20
expertise in clinical trials and research;
21
(v) representatives from relevant non-
22
profit organizations with expertise in clin-
23
ical research; and
24
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•HR 1117 IH
(vi) other representatives, as the Sec-
1
retary determines appropriate.
2
(B) LIMITATIONS.—The non-Federal mem-
3
bers of the Committee shall compose not more
4
than one-half, and not less than one-third, of
5
the total membership of the Committee.
6
(C) APPOINTMENT.—The Secretary shall
7
appoint the non-Federal members of the Com-
8
mittee.
9
(D) TERMS.—The non-Federal members of
10
the Committee shall serve for a term of 4 years,
11
and may be reappointed for 1 additional 4-year
12
term. Any non-Federal member appointed to fill
13
a vacancy for an unexpired term shall be ap-
14
pointed for the remainder of such term. A non-
15
Federal member may serve after the expiration
16
of the member’s term until a successor has
17
taken office.
18
(d) ADMINISTRATIVE SUPPORT.—The Secretary shall
19
provide the Committee such administrative support as the
20
Secretary determines to be necessary for carrying out this
21
section.
22
(e) MEETINGS.—The Committee shall meet at least
23
2 times each year and shall convene public meetings, as
24
appropriate, to fulfill its duties under subsection (b).
25
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•HR 1117 IH
(f) REPORT TO CONGRESS.—
1
(1) IN GENERAL.—Not later than 1 year after
2
the date of enactment of this Act, and every other
3
year thereafter, the Committee shall prepare and
4
submit to the Secretary, the Committee on Health,
5
Education, Labor, and Pensions of the Senate, and
6
the Committee on Energy and Commerce of the
7
House of Representatives a report on—
8
(A) the progress of Federal agencies in im-
9
plementing the recommendations and imple-
10
mentation plan described in subsection (b)(3);
11
(B) Federal activities undertaken to ad-
12
vance the inclusion of pregnant and lactating
13
women in clinical research; and
14
(C) additional recommendations for the
15
Secretary regarding Federal activities to ad-
16
dress gaps in knowledge and research regarding
17
safe and effective therapies for pregnant and
18
lactating women.
19
(2)
PUBLIC
AVAILABILITY.—The
Secretary
20
shall make the reports required by paragraph (1)
21
available on a public website of the Department of
22
Health and Human Services.
23
(g) SUPPLEMENTAL
REPORT
ON
DEPARTMENT
24
GUIDANCE.—
25
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(1) IN GENERAL.—Not later than 2 years after
1
the date of enactment of this Act, the Committee
2
shall prepare and submit to the Secretary, the Com-
3
mittee on Health, Education, Labor, and Pensions
4
of the Senate, and the Committee on Energy and
5
Commerce of the House of Representatives a report
6
to inform guidance of the Department of Health and
7
Human Services to facilitate the conduct of clinical
8
research involving pregnant and lactating women.
9
(2) CONTENTS.—The report under paragraph
10
(1) shall include—
11
(A) information on which clinical studies
12
require consent from both biological parents, in-
13
cluding information quantifying how requiring
14
consent from both biological parents limits par-
15
ticipation in such clinical studies;
16
(B) best practices and recommendations
17
for institutional review boards related to the in-
18
clusion of pregnant and lactating women in
19
clinical research, including information on suc-
20
cesses and challenges of using a centralized in-
21
stitutional review board; and
22
(C) an evaluation of statutory programs
23
enacted to spur pediatric-specific information in
24
Food and Drug Administration-approved thera-
25
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•HR 1117 IH
pies, such as the Best Pharmaceuticals for Chil-
1
dren Act (Public Law 107–109) and the Pedi-
2
atric Research Equity Act of 2008 (Public Law
3
108–155), and how approaches taken in such
4
programs can be applied to clinical research in-
5
cluding pregnant and lactating women.
6
(3)
PUBLIC
AVAILABILITY.—The
Secretary
7
shall make the report required by paragraph (1)
8
available on a public website of the Department of
9
Health and Human Services.
10
(h) TERMINATION.—
11
(1) IN GENERAL.—The Committee shall termi-
12
nate on the date that is 5 years after the date on
13
which the Committee is established under subsection
14
(a).
15
(2) EXTENSION.—The Secretary may extend
16
the operation of the Committee for up to 3 addi-
17
tional 2-year periods following the 5-year period de-
18
scribed in paragraph (1) if the Secretary determines
19
that the extension is appropriate to monitor the im-
20
plementation of the recommendations and implemen-
21
tation plan described in subsection (b)(3) or any ad-
22
ditional recommendations made by the
[Text truncated for display. Full text available on Congress.gov.]