[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8651 Introduced in House (IH)]
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119th CONGRESS
2d Session
H. R. 8651
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
May 4, 2026
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 2026''.
SEC. 2. UPDATING FDA REGULATIONS TO INCLUDE PREGNANT WOMEN IN CLINICAL
TRIALS.
(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 (referred to in this Act as
the ``Secretary''), acting through the Commissioner of Food and Drugs,
shall, to the extent practicable and consistent with other applicable
Federal statutory law, 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 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. RAISING AWARENESS OF RESEARCH THAT INCLUDES PREGNANT AND
LACTATING WOMEN.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary)'', in consultation
with the heads of other relevant Federal agencies, including the
Director of the Centers for Disease Control and Prevention and the
Director of the National Institutes of Health, shall establish and
implement an education campaign designed to educate patients, their
families, health care providers, and other target audiences on--
(1) how including pregnant and lactating women in clinical
research can benefit maternal and infant health;
(2) available registries and clinical trials that include
pregnant and lactating women;
(3) the role registries and other postmarket surveillance
activities have in studying drugs used by pregnant and
lactating women; and
(4) how pregnant and lactating women can easily identify
and enroll in clinical trials or registries.
(b) Consultation.--In carrying out this section, the Secretary
shall consult with--
(1) organizations with expertise related to the health of
women and infants, including such organizations 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
infants;
(3) relevant industry representatives; and
(4) other representatives, as appropriate.
(c) Planning.--In establishing the campaign under subsection (a),
the Secretary, 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 resource needs for each target audience and
best practices to reach each such audience; and
(4) test appropriate messaging strategies, including risk
communication messaging, for each target audience.
(d) Dissemination.--The Secretary shall publish on a public
website, and regularly update, the campaign materials described in this
section, and shall ensure that such website--
(1) includes information on clinical trials and registries
enrolling pregnant and lactating women; and
(2) provides a user-friendly interface for patients, their
families, health care providers, and other target audiences.
(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000 for each of fiscal
years 2027 through 2031.
SEC. 4. 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 drugs 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 NICHD 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) organizations with expertise related to the health of
pregnant women, lactating women, or children, including such
organizations representing populations with high rates of
maternal mortality and morbidity.
(d) Research Requirements.--The Director of the National Institutes
of Health shall ensure that--
(1) research projects carried out under subsection (a) are
conducted by individuals who have the expertise to rigorously
evaluate the best-available scientific research; and
(2) the findings from such research projects are based on a
preponderance of the best-available, peer-reviewed scientific
evidence.
(e) Public Comment.--The Secretary shall provide an opportunity for
public comment on the program under this section.
(f) 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 fiscal year
for the 5 fiscal years beginning immediately 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
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).
(g) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section such sums as may be necessary
for each of fiscal years 2027 through 2031.
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