HR 8651

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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. <all>