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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Advancing Safe Medi5 cations for Moms and Babies Act of 2023’’. 

6 SEC. 2. UPDATING FDA REGULATIONS TO REMOVE PREG7 NANT WOMEN AS A VULNERABLE RESEARCH 

8 POPULATION. 

9 (a) PURPOSES.—The purposes of this section are— 


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1 (1) to facilitate compliance with applicable Fed2 eral regulations relating to the protection of preg3 nant women participating in research as subjects; 

4 and 

5 (2) to promote the inclusion of pregnant women 

6 in clinical research. 

7 (b) HARMONIZATION.—For the purposes specified in 

8 subsection (a), the Secretary of Health and Human Serv9 ices (in this Act referred to as the ‘‘Secretary’’) shall, to 

10 the extent practicable and consistent with other applicable 

11 statutes, issue such regulations as may be appropriate to 

12 harmonize the regulations of the Food and Drug Adminis13 tration relating to the protection of human subjects, in14 cluding parts 50 and 56 of title 21, Code of Federal Regu15 lations, with the latest regulations of the Department of 

16 Health and Human Services relating to the inclusion of 

17 pregnant women as subjects in clinical research. 

18 (c) DEADLINE.—The Secretary of Health and 

19 Human Services shall finalize the regulations required by 

20 subsection (b) not later than 180 days after the date of 

21 enactment of this Act. 

22 SEC. 3. CLEARINGHOUSE OF CLINICAL TRIALS AND REG23 ISTRIES. 

24 (a) IN GENERAL.—The Secretary, acting through the 

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1 sultation with the Commissioner of Food and Drugs and 

2 the heads of other relevant Federal departments and agen3 cies, shall establish and maintain a national clearinghouse 

4 of educational materials and current information on reg5 istries and clinical trials that enroll pregnant and lactating 

6 women in order to— 

7 (1) enable pregnant and lactating women, their 

8 families, and health care professionals to easily iden9 tify and enroll in registries and clinical trials; 

10 (2) educate pregnant and lactating women, 

11 their families, and health care professionals on the 

12 importance of enrolling in registries and clinical 

13 trials; and 

14 (3) inform pregnant and lactating women, their 

15 families, and health care professionals about the 

16 general requirements, commitments, and benefits as17 sociated with participating in a registry or clinical 

18 trial. 

19 (b) REQUIREMENTS.—The Secretary, acting through 

20 the Director of the National Institutes of Health, and in 

21 consultation with the Commissioner of Food and Drugs 

22 and the heads of other relevant Federal departments and 

23 agencies, shall ensure that the clearinghouse under sub24 section (a)— 

25 (1) is accessible by means of the internet; 


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1 (2) is updated on a regular basis, not less than 

2 quarterly; 

3 (3) is designed for consumers, incorporates a 

4 user-friendly interface, and is searchable; 

5 (4) includes links to related public and private 

6 sector resources on registries and clinical trials de7 scribed in subsection (a); and 

8 (5) is available to the public by October 1, 

9 2025. 

10 (c) PLANNING.— 

11 (1) IN GENERAL.—In establishing the clearing12 house under subsection (a), the Secretary, shall— 

13 (A) develop criteria for which registries 

14 and clinical trials are eligible for listing in the 

15 clearinghouse under subsection (a); 

16 (B) establish a procedure for archiving 

17 closed registries and clinical trials; and 

18 (C) identify educational resources needed 

19 for the clearinghouse. 

20 (2) PUBLIC INPUT.—The Secretary shall solicit 

21 public input on content to be included in the clear22 inghouse under subsection (a). 

23 (d) AUTHORIZATION OF APPROPRIATIONS.—To carry 

24 out this section, there are authorized to be appropriated— 


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1 (1) $4,000,000 for the period of fiscal years 

2 2024 through 2025; and 

3 (2) $3,000,000 for the period of fiscal years 

4 2026 through 2028. 

5 SEC. 4. COORDINATING COMMITTEE ON RESEARCH SPE6 CIFIC TO PREGNANT AND LACTATING 

7 WOMEN. 

8 (a) ESTABLISHMENT.—Not later than 90 days after 

9 the date of enactment of this Act, the Secretary shall es10 tablish a committee, in accordance with the Federal Advi11 sory Committee Act (5 U.S.C. App.), to be known as the 

12 Committee on Research Specific to Pregnant and Lac13 tating Women or the PRGLAC Committee (in this section 

14 referred to as the ‘‘Committee’’) to advise on coordinating 

15 Federal activities to address gaps in knowledge and re16 search regarding safe and effective therapies for pregnant 

17 and lactating women. 

18 (b) DUTIES.—The Committee shall— 

19 (1) advise on coordinating Federal activities to 

20 promote the inclusion of pregnant and lactating 

21 women in clinical research; 

22 (2) promote opportunities for Federal agencies 

23 and private actors to advance the inclusion of preg24 nant and lactating women in clinical research; 


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1 (3) develop and annually update a summary of 

2 Federal agency progress toward implementing rec3 ommendations included in the September 2018 Re4 port to the Secretary of Health and Human Serv5 ices, and the August 2020 Report Implementation 

6 Plan to the Secretary of Health and Human Serv7 ices, prepared by the Task Force on Research Spe8 cific to Pregnant Women and Lactating Women; 

9 (4) identify new recommendations for the Sec10 retary regarding Federal activities to address gaps 

11 in knowledge and research regarding safe and effec12 tive therapies for pregnant and lactating women; 

13 and 

14 (5) receive updates on private sector and inter15 national efforts to include pregnant and lactating 

16 women in clinical research. 

17 (c) MEMBERSHIP.— 

18 (1) IN GENERAL.—The Committee shall be 

19 composed of— 

20 (A) the Federal members listed in para21 graph (2); and 

22 (B) the non-Federal members appointed 

23 pursuant to paragraph (3). 


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1 (2) FEDERAL MEMBERS.—The Federal mem2 bers of the Committee shall consist of the following 

3 Federal officials (or their designees): 

4 (A) The Director of the Centers for Dis5 ease Control and Prevention. 

6 (B) The Director of the National Institutes 

7 of Health, the Director of the Eunice Kennedy 

8 Shriver National Institute of Child Health and 

9 Human Development, the Director of the Office 

10 of Research on Women’s Health of the National 

11 Institutes of Health, and the directors of such 

12 other national research institutes and national 

13 centers of the National Institutes of Health as 

14 the Secretary determines appropriate. 

15 (C) The Commissioner of Food and Drugs. 

16 (D) The Director of the Agency for 

17 Healthcare Research and Quality. 

18 (E) The Director of the Office on Women’s 

19 Health of the Department of Health and 

20 Human Services. 

21 (F) The Director of the National Vaccine 

22 Program. 

23 (G) The Director of the Office for Human 

24 Research Protections of the Department of 

25 Health and Human Services. 


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1 (H) The Administrator of Health Re2 sources and Services Administration. 

3 (I) The head of any other research-related 

4 agency or department not described in subpara5 graphs (A) through (H) as the Secretary deter6 mines appropriate, which may include the De7 partment of Veterans Affairs and the Depart8 ment of Defense. 

9 (3) NON-FEDERAL MEMBERS.— 

10 (A) IN GENERAL.—The non-Federal mem11 bers of the Committee shall consist of— 

12 (i) representatives from relevant med13 ical societies with subject matter expertise 

14 on pregnant women, lactating women, or 

15 children; 

16 (ii) representatives from nonprofit or17 ganizations with expertise related to the 

18 health of women and children; 

19 (iii) relevant industry representatives; 

20 (iv) individuals with ethical and legal 

21 expertise in clinical trials and research; 

22 (v) representatives from relevant non23 profit organizations with expertise in clin24 ical research; and 


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1 (vi) other representatives, as the Sec2 retary determines appropriate. 

3 (B) LIMITATIONS.—The non-Federal mem4 bers of the Committee shall compose not more 

5 than one-half, and not less than one-third, of 

6 the total membership of the Committee. 

7 (C) APPOINTMENT.—The Secretary shall 

8 appoint the non-Federal members of the Com9 mittee. 

10 (D) TERMS.—The non-Federal members of 

11 the Committee shall serve for a term of 4 years, 

12 and may be reappointed for 1 additional 4-year 

13 term. Any non-Federal member appointed to fill 

14 a vacancy for an unexpired term shall be ap15 pointed for the remainder of such term. A non16 Federal member may serve after the expiration 

17 of the member’s term until a successor has 

18 taken office. 

19 (d) ADMINISTRATIVE SUPPORT.—The Secretary shall 

20 provide the Committee such administrative support as the 

21 Secretary determines to be necessary for carrying out this 

22 section. 

23 (e) MEETINGS.—The Committee shall meet at least 

24 2 times each year and shall convene public meetings, as 

25 appropriate, to fulfill its duties under subsection (b). 


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1 (f) REPORT TO CONGRESS.— 

2 (1) IN GENERAL.—Not later than 1 year after 

3 the date of enactment of this Act, and every other 

4 year thereafter, the Committee shall prepare and 

5 submit to the Secretary, the Committee on Health, 

6 Education, Labor, and Pensions of the Senate, and 

7 the Committee on Energy and Commerce of the 

8 House of Representatives a report on— 

9 (A) the progress of Federal agencies in im10 plementing the recommendations and imple11 mentation plan described in subsection (b)(3); 

12 (B) Federal activities undertaken to ad13 vance the inclusion of pregnant and lactating 

14 women in clinical research; and 

15 (C) additional recommendations for the 

16 Secretary regarding Federal activities to ad17 dress gaps in knowledge and research regarding 

18 safe and effective therapies for pregnant and 

19 lactating women. 

20 (2) PUBLIC AVAILABILITY.—The Secretary 

21 shall make the reports required by paragraph (1) 

22 available on a public website of the Department of 

23 Health and Human Services. 

24 (g) SUPPLEMENTAL REPORT ON DEPARTMENT

25 GUIDANCE.— 


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1 (1) IN GENERAL.—Not later than 2 years after 

2 the date of enactment of this Act, the Committee 

3 shall prepare and submit to the Secretary, the Com4 mittee on Health, Education, Labor, and Pensions 

5 of the Senate, and the Committee on Energy and 

6 Commerce of the House of Representatives a report 

7 to inform guidance of the Department of Health and 

8 Human Services to facilitate the conduct of clinical 

9 research involving pregnant and lactating women. 

10 (2) CONTENTS.—The report under paragraph 

11 (1) shall include— 

12 (A) information on which clinical studies 

13 require consent from both biological parents, in14 cluding information quantifying how requiring 

15 consent from both biological parents limits par16 ticipation in such clinical studies; 

17 (B) best practices and recommendations 

18 for institutional review boards related to the in19 clusion of pregnant and lactating women in 

20 clinical research, including information on suc21 cesses and challenges of using a centralized in22 stitutional review board; and 

23 (C) an evaluation of statutory programs 

24 enacted to spur pediatric-specific information in 

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1 pies, such as the Best Pharmaceuticals for Chil2 dren Act (Public Law 107–109) and the Pedi3 atric Research Equity Act of 2008 (Public Law 

4 108–155), and how approaches taken in such 

5 programs can be applied to clinical research in6 cluding pregnant and lactating women. 

7 (3) PUBLIC AVAILABILITY.—The Secretary 

8 shall make the report required by paragraph (1) 

9 available on a public website of the Department of 

10 Health and Human Services. 

11 (h) TERMINATION.— 

12 (1) IN GENERAL.—The Committee shall termi13 nate on the date that is 5 years after the date on 

14 which the Committee is established under subsection 

15 (a). 

16 (2) EXTENSION.—The Secretary may extend 

17 the operation of the Committee for up to 3 addi18 tional 2-year periods following the 5-year period de19 scribed in paragraph (1) if the Secretary determines 

20 that the extension is appropriate to monitor the im21 plementation of the recommendations and implemen22 tation plan described in subsection (b)(3) or any ad23 ditional recommendations made by the Committee. 


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1 SEC. 5. RAISING AWARENESS OF RESEARCH THAT IN2 CLUDES PREGNANT AND LACTATING WOMEN 

3 IN CLINICAL RESEARCH. 

4 (a) IN GENERAL.—The Secretary, acting through the 

5 Director of the National Institutes of Health, in consulta6 tion with the heads of other relevant Federal agencies, 

7 shall establish and implement an education campaign de8 signed to— 

9 (1) educate the public on the importance of— 

10 (A) including pregnant and lactating 

11 women in clinical research to better inform 

12 health care decisions on the safety and effec13 tiveness of medications for pregnant and lac14 tating women before, during, and after preg15 nancy; 

16 (B) registries and clinical trials that in17 clude pregnant and lactating women; 

18 (2) encourage and facilitate participation by 

19 pregnant and lactating women in clinical research; 

20 (3) improve the general understanding of the 

21 critical role registries and other postmarket surveil22 lance activities have in collecting data related to the 

23 use of medications by pregnant and lactating 

24 women; 


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1 (4) improve the understanding of available clin2 ical trials and registries that enroll pregnant and 

3 lactating women; 

4 (5) encourage pregnant and lactating women to 

5 seek additional information about such opportunities 

6 to participate in clinical research; 

7 (6) encourage health care providers to make in8 formation on clinical research available to pregnant 

9 and lactating women; and 

10 (7) facilitate access to and enrollment in such 

11 research by pregnant and lactating women. 

12 (b) CONSULTATION.—In carrying out this section, 

13 the Secretary shall consult with— 

14 (1) nonprofit organizations with expertise re15 lated to the health of women and children, including 

16 those representing populations with high rates of 

17 maternal mortality and morbidity; 

18 (2) representatives from relevant medical soci19 eties with subject matter expertise on pregnant 

20 women, lactating women, or children; 

21 (3) relevant industry representatives; and 

22 (4) other representatives, as appropriate. 

23 (c) PLANNING.—In establishing the campaign under 

24 subsection (a), the Secretary, acting through the Director 


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1 of the National Institutes of Health, in consultation with 

2 the heads of other relevant Federal agencies, shall— 

3 (1) conduct a needs assessment to— 

4 (A) evaluate existing resources; and 

5 (B) identify barriers to awareness and op6 portunities to fill gaps and address barriers; 

7 (2) identify target audiences for the campaign; 

8 (3) identify best practices to reach each such 

9 target audience; 

10 (4) test appropriate messaging strategies, in11 cluding risk communication messaging, for each tar12 get audience; and 

13 (5) coordinate with the clearinghouse estab14 lished under section 3. 

15 (d) AUTHORIZATION OF APPROPRIATIONS.—To carry 

16 out this section, there is authorized to be appropriated 

17 $5,000,000 for the period of fiscal years 2024 through 

18 2028. 

19 SEC. 6. RESEARCH PRIORITIZATION PROCESS FOR PREG20 NANT AND LACTATING WOMEN AT THE EU21 NICE KENNEDY SHRIVER NATIONAL INSTI22 TUTE OF CHILD HEALTH AND HUMAN DEVEL23 OPMENT. 

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1 nice Kennedy Shriver National Institute of Child Health 

2 and Human Development (referred to in this section as 

3 ‘‘NICHD’’), shall carry out priority research projects on 

4 existing and new medications prescribed for pregnant and 

5 lactating women. 

6 (b) RESEARCH PRIORITIZATION PROCESS.—The Di7 rector of the National Institutes of Health shall establish 

8 a research prioritization process to determine which pro9 posed research projects should receive priority funding 

10 under this section. Such research prioritization process 

11 shall take into account the following factors: 

12 (1) The available evidence, including whether 

13 there is an unmet medical need or gap in scientific 

14 information relevant to treatment of pregnant and 

15 lactating women with specific diseases or conditions. 

16 (2) The feasibility of research, including the 

17 prevalence of a disease or condition in pregnant and 

18 lactating women and the availability of investigators 

19 with expertise in studying such disease or condition. 

20 (3) The potential impact of research, including 

21 the severity of the disease or condition in pregnant 

22 and lactating women, the current cost of treating 

23 the disease or condition in pregnant and lactating 

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1 native treatments for the disease or condition in 

2 pregnant and lactating women. 

3 (c) CONSULTATION.—In developing the research 

4 prioritization process described in subsection (b), the Di5 rector of the National Institutes of Health shall seek feed6 back from— 

7 (1) the existing research networks of the Na8 tional Institute of Child Health and Human Devel9 opment with expertise in clinical research involving 

10 pregnant and lactating women; 

11 (2) relevant medical societies with subject mat12 ter expertise on pregnant women, lactating women, 

13 or children; and 

14 (3) nonprofit organizations with expertise re15 lated to the health of pregnant women, lactating 

16 women, or children, including those representing 

17 populations with high rates of maternal mortality 

18 and morbidity. 

19 (d) PUBLIC COMMENT.—The Secretary shall provide 

20 an opportunity for public comment on the program under 

21 this section. 

22 (e) ACCOUNTABILITY AND OVERSIGHT.— 

23 (1) WORK PLAN.—Not later than 180 days 

24 after the date of enactment of this Act, the Director 

25 of the National Institutes of Health shall submit to 


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1 the Committee on Health, Education, Labor, and 

2 Pensions and the Committee on Appropriations of 

3 the Senate and the Committee on Energy and Com4 merce and the Committee on Appropriations of the 

5 House of Representatives a work plan for— 

6 (A) funding priority research projects 

7 under subsection (a); and 

8 (B) developing the research prioritization 

9 process under subsection (b). 

10 (2) REPORTS.—Not later than October 1 of 

11 each of fiscal years 2024 through 2028, the Director 

12 of the National Institutes of Health shall submit to 

13 the Committee on Health, Education, Labor, and 

14 Pensions and the Committee on Appropriations of 

15 the Senate and the Committee on Energy and Com16 merce and the Committee on Appropriations of the 

17 House of Representatives a report on the program 

18 under this section, including— 

19 (A) the amount of money obligated or ex20 pended in the prior fiscal year for each priority 

21 research project under subsection (a); 

22 (B) a description of each such project; and 

23 (C) the rationale for prioritizing each such 

24 project according to the process under sub25 section (b). 


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1 (f) AUTHORIZATION OF APPROPRIATIONS.—To carry 

2 out this section, there is authorized to be appropriated 

3 $50,000,000 for the period of fiscals year 2024 through 

4 2028. 

Æ 


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