H.R. 8651

[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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