I 

114TH CONGRESS 

2D SESSION H. R. 5219 

To provide for the establishment of the Task Force on Research Specific 

to Pregnant Women and Lactating Women, to require an annual report 

to Congress on approved new drug applications with information on 

pregnancy and lactation, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 12, 2016 

Ms. HERRERA BEUTLER (for herself and Ms. CASTOR of Florida) introduced 

the following bill; which was referred to the Committee on Energy and 

Commerce 

A BILL 

To provide for the establishment of the Task Force on Research Specific to Pregnant Women and Lactating 

Women, to require an annual report to Congress on 

approved new drug applications with information on 

pregnancy and lactation, 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 ‘‘Safe Medications for 

5 Moms and Babies Act of 2016’’. 

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1 SEC. 2. TASK FORCE ON RESEARCH SPECIFIC TO PREG2 NANT WOMEN AND LACTATING WOMEN. 

3 (a) TASK FORCE.— 

4 (1) ESTABLISHMENT.—Not later than 90 days 

5 after the date of enactment of this Act, the Sec6 retary of Health and Human Services (in this sec7 tion referred to as the ‘‘Secretary’’) shall establish 

8 a task force, in accordance with the Federal Advi9 sory Committee Act (5 U.S.C. App.), to be known 

10 as the Task Force on Research Specific to Pregnant 

11 Women and Lactating Women (in this section re12 ferred to as the ‘‘Task Force’’). 

13 (2) DUTIES.—The Task Force shall provide ad14 vice and guidance to the Secretary regarding Fed15 eral activities related to identifying and addressing 

16 gaps in knowledge and research regarding safe and 

17 effective therapies for pregnant women and lactating 

18 women, including the development of such therapies 

19 and the collaboration on and coordination of such 

20 activities. 

21 (3) MEMBERSHIP.— 

22 (A) FEDERAL MEMBERS.—The Federal 

23 members of the Task Force shall be composed 

24 of the following members (or their designees): 

25 (i) The Director of the Centers for 

26 Disease Control and Prevention. 

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1 (ii) The Director of the National In2 stitutes of Health, the Director of the Eu3 nice Kennedy Shriver National Institute of 

4 Child Health and Human Development, 

5 and the directors of such other national re6 search institutes as the Secretary deter7 mines appropriate. 

8 (iii) The Commissioner of Food and 

9 Drugs. 

10 (iv) The Director of the Office on 

11 Women’s Health. 

12 (v) The Director of the National Vac13 cine Program Office. 

14 (vi) The head of any other research15 related agency or department not described 

16 in clauses (i) through (v) that the Sec17 retary determines appropriate, which may 

18 include the Department of Veterans Af19 fairs and the Department of Defense. 

20 (B) NON-FEDERAL MEMBERS.—The non21 Federal members of the Task Force shall be 

22 composed of the following members: 

23 (i) Representatives from relevant med24 ical societies with subject matter expertise 

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1 on pregnant women, lactating women, or 

2 children. 

3 (ii) Nonprofit organizations with ex4 pertise related to the health of women and 

5 children. 

6 (iii) Relevant industry representatives. 

7 (iv) Representatives of patient or con8 sumer advocacy organizations. 

9 (v) Other representatives, as appro10 priate. 

11 (C) LIMITATIONS.—The non-Federal mem12 bers described in subparagraph (B) shall— 

13 (i) compose not more than one-half, 

14 and not less than one-third, of the total 

15 membership of the Task Force; and 

16 (ii) be appointed by the Secretary. 

17 (4) TERMINATION.— 

18 (A) IN GENERAL.—Subject to subpara19 graph (B), the Task Force shall terminate on 

20 the date that is 2 years after the date on which 

21 the Task Force is established under paragraph 

22 (1). 

23 (B) EXTENSION.—The Secretary may ex24 tend the operation of the Task Force for one 

25 additional 2-year period following the 2-year pemstockstill on DSK3G9T082PROD with BILLS

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1 riod described in subparagraph (A), if the Sec2 retary determines that the extension is appro3 priate for carrying out the purpose of this sec4 tion. 

5 (5) MEETINGS.—The Task Force shall meet 

6 not less than 2 times each year and shall convene 

7 public meetings, as appropriate, to fulfill its duties 

8 under paragraph (2). 

9 (6) TASK FORCE REPORT TO CONGRESS.—Not 

10 later than 18 months after the date on which the 

11 Task Force is established under paragraph (1), and 

12 not later than 36 and 48 months after such date if 

13 the Secretary extends the operation of the Task 

14 Force pursuant to paragraph (4)(B), the Task Force 

15 shall prepare and submit to the Secretary, the Com16 mittee on Health, Education, Labor, and Pensions 

17 of the Senate, and the Committee on Energy and 

18 Commerce of the House of Representatives a report 

19 on gaps in knowledge and research regarding safe 

20 and effective therapies for pregnant women and lac21 tating women. Each such report shall, at a min22 imum, include each of the following: 

23 (A) A plan to identify and address gaps in 

24 knowledge and research regarding safe and ef25 fective therapies for pregnant women and lacmstockstill on DSK3G9T082PROD with BILLS

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1 tating women, including the development of 

2 such therapies. 

3 (B) Ethical issues surrounding the inclu4 sion of pregnant women and lactating women in 

5 clinical research. 

6 (C) Effective communication strategies 

7 with health care providers and the public on in8 formation relevant to pregnant women and lac9 tating women. 

10 (D) Identification of Federal activities, in11 cluding— 

12 (i) the state of research involving 

13 pregnant and lactating women; 

14 (ii) recommendations for the coordina15 tion of, and collaboration on, research re16 lated to pregnant women and lactating 

17 women; 

18 (iii) dissemination of research findings 

19 and information relevant to pregnant 

20 women and lactating women to providers 

21 and the public; and 

22 (iv) existing Federal efforts and pro23 grams to improve the scientific under24 standing of the health impacts of therapies 

25 on pregnant women and lactating women 

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1 and related birth and pediatric outcomes, 

2 including with respect to pharmacokinetics, 

3 pharmacodynamics, and toxicities. 

4 (E) Recommendations to improve the de5 velopment of safe and effective therapies for 

6 pregnant women and lactating women. 

7 (b) CONFIDENTIALITY.—Nothing in this section au8 thorizes the Secretary to disclose any information that is 

9 a trade secret, or other privileged or confidential informa10 tion, described in section 552(b)(4) of title 5, United 

11 States Code, or section 1905 of title 18, United States 

12 Code. 

13 (c) UPDATING PROTECTIONS FOR PREGNANT

14 WOMEN AND LACTATING WOMEN IN RESEARCH.— 

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

16 the date of enactment of this Act, and not later than 

17 3 and 4 years after such date if the Secretary ex18 tends the operation of the Task Force pursuant to 

19 subsection (a)(4)(B), the Secretary, taking into con20 sideration any recommendations of the Task Force 

21 available at such time and in consultation with the 

22 heads of relevant agencies of the Department of 

23 Health and Human Services, shall, as appropriate, 

24 update regulations and guidance, as applicable, remstockstill on DSK3G9T082PROD with BILLS

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1 garding the inclusion of pregnant women and lac2 tating women in clinical research. 

3 (2) CRITERIA FOR EXCLUDING PREGNANT OR

4 LACTATING WOMEN.—In updating any regulations or 

5 guidance described in paragraph (1), the Secretary 

6 shall consider any appropriate criteria to be used by 

7 institutional review boards and individuals reviewing 

8 grant proposals for excluding from participating in 

9 human subject research pregnant women or lac10 tating women as a study population requiring addi11 tional protections. 

12 SEC. 3. ANNUAL REPORT FROM FDA ON APPROVED NEW 

13 DRUG APPLICATIONS WITH INFORMATION 

14 ON PREGNANCY AND LACTATION. 

15 Not later than 1 year after the date of enactment 

16 of this Act, and not less than annually for the succeeding 

17 9 years, the Commissioner of Food and Drugs shall sub18 mit to the appropriate committees of the Congress a re19 port on— 

20 (1) the number of new drug applications and 

21 supplements to such applications approved or li22 censed by the Food and Drug Administration under 

23 section 505(c) of the Federal Food, Drug, and Cos24 metic Act or section 351(a) of the Public Health 

25 Services Act (42 U.S.C. 262(a)) based on research 

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1 that included pregnant women or lactating women in 

2 trials; 

3 (2) the number of new drug applications and 

4 supplements to such applications so approved or li5 censed that included data on the excretion of the 

6 drug in breast milk; 

7 (3) the number of new drug applications and 

8 supplements to such applications so approved or li9 censed with required postmarket studies in pregnant 

10 or breastfeeding women; and 

11 (4) the number of drugs with respect to which 

12 a labeling change is made to include new informa13 tion regarding use in pregnant or breastfeeding 

14 women. 

Æ 

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