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 Re-
search 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safe Medications for 
Moms and Babies Act of 2016’’. 
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SEC. 2. TASK FORCE ON RESEARCH SPECIFIC TO PREG-
NANT WOMEN AND LACTATING WOMEN. 
(a) TASK FORCE.— 
(1) ESTABLISHMENT.—Not later than 90 days 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services (in this sec-
tion referred to as the ‘‘Secretary’’) shall establish 
a task force, in accordance with the Federal Advi-
sory Committee Act (5 U.S.C. App.), to be known 
as the Task Force on Research Specific to Pregnant 
Women and Lactating Women (in this section re-
ferred to as the ‘‘Task Force’’). 
(2) DUTIES.—The Task Force shall provide ad-
vice and guidance to the Secretary regarding Fed-
eral activities related to identifying and addressing 
gaps in knowledge and research regarding safe and 
effective therapies for pregnant women and lactating 
women, including the development of such therapies 
and the collaboration on and coordination of such 
activities. 
(3) MEMBERSHIP.— 
(A) FEDERAL
MEMBERS.—The Federal 
members of the Task Force shall be composed 
of the following members (or their designees): 
(i) The Director of the Centers for 
Disease Control and Prevention. 
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(ii) The Director of the National In-
stitutes of Health, the Director of the Eu-
nice Kennedy Shriver National Institute of 
Child Health and Human Development, 
and the directors of such other national re-
search institutes as the Secretary deter-
mines appropriate. 
(iii) The Commissioner of Food and 
Drugs. 
(iv) The Director of the Office on 
Women’s Health. 
(v) The Director of the National Vac-
cine Program Office. 
(vi) The head of any other research- 
related agency or department not described 
in clauses (i) through (v) that the Sec-
retary determines appropriate, which may 
include the Department of Veterans Af-
fairs and the Department of Defense. 
(B) NON-FEDERAL MEMBERS.—The non- 
Federal members of the Task Force shall be 
composed of the following members: 
(i) Representatives from relevant med-
ical societies with subject matter expertise 
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on pregnant women, lactating women, or 
children. 
(ii) Nonprofit organizations with ex-
pertise related to the health of women and 
children. 
(iii) Relevant industry representatives. 
(iv) Representatives of patient or con-
sumer advocacy organizations. 
(v) Other representatives, as appro-
priate. 
(C) LIMITATIONS.—The non-Federal mem-
bers described in subparagraph (B) shall— 
(i) compose not more than one-half, 
and not less than one-third, of the total 
membership of the Task Force; and 
(ii) be appointed by the Secretary. 
(4) TERMINATION.— 
(A) IN
GENERAL.—Subject to subpara-
graph (B), the Task Force shall terminate on 
the date that is 2 years after the date on which 
the Task Force is established under paragraph 
(1). 
(B) EXTENSION.—The Secretary may ex-
tend the operation of the Task Force for one 
additional 2-year period following the 2-year pe-
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riod described in subparagraph (A), if the Sec-
retary determines that the extension is appro-
priate for carrying out the purpose of this sec-
tion. 
(5) MEETINGS.—The Task Force shall meet 
not less than 2 times each year and shall convene 
public meetings, as appropriate, to fulfill its duties 
under paragraph (2). 
(6) TASK FORCE REPORT TO CONGRESS.—Not 
later than 18 months after the date on which the 
Task Force is established under paragraph (1), and 
not later than 36 and 48 months after such date if 
the Secretary extends the operation of the Task 
Force pursuant to paragraph (4)(B), the Task Force 
shall prepare and submit to the Secretary, the Com-
mittee on Health, Education, Labor, and Pensions 
of the Senate, and the Committee on Energy and 
Commerce of the House of Representatives a report 
on gaps in knowledge and research regarding safe 
and effective therapies for pregnant women and lac-
tating women. Each such report shall, at a min-
imum, include each of the following: 
(A) A plan to identify and address gaps in 
knowledge and research regarding safe and ef-
fective therapies for pregnant women and lac-
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tating women, including the development of 
such therapies. 
(B) Ethical issues surrounding the inclu-
sion of pregnant women and lactating women in 
clinical research. 
(C) Effective communication strategies 
with health care providers and the public on in-
formation relevant to pregnant women and lac-
tating women. 
(D) Identification of Federal activities, in-
cluding— 
(i) the state of research involving 
pregnant and lactating women; 
(ii) recommendations for the coordina-
tion of, and collaboration on, research re-
lated to pregnant women and lactating 
women; 
(iii) dissemination of research findings 
and information relevant to pregnant 
women and lactating women to providers 
and the public; and 
(iv) existing Federal efforts and pro-
grams to improve the scientific under-
standing of the health impacts of therapies 
on pregnant women and lactating women 
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and related birth and pediatric outcomes, 
including with respect to pharmacokinetics, 
pharmacodynamics, and toxicities. 
(E) Recommendations to improve the de-
velopment of safe and effective therapies for 
pregnant women and lactating women. 
(b) CONFIDENTIALITY.—Nothing in this section au-
thorizes the Secretary to disclose any information that is 
a trade secret, or other privileged or confidential informa-
tion, described in section 552(b)(4) of title 5, United 
States Code, or section 1905 of title 18, United States 
Code. 
(c) 
UPDATING
PROTECTIONS
FOR
PREGNANT 
WOMEN AND LACTATING WOMEN IN RESEARCH.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act, and not later than 
3 and 4 years after such date if the Secretary ex-
tends the operation of the Task Force pursuant to 
subsection (a)(4)(B), the Secretary, taking into con-
sideration any recommendations of the Task Force 
available at such time and in consultation with the 
heads of relevant agencies of the Department of 
Health and Human Services, shall, as appropriate, 
update regulations and guidance, as applicable, re-
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garding the inclusion of pregnant women and lac-
tating women in clinical research. 
(2) CRITERIA FOR EXCLUDING PREGNANT OR 
LACTATING WOMEN.—In updating any regulations or 
guidance described in paragraph (1), the Secretary 
shall consider any appropriate criteria to be used by 
institutional review boards and individuals reviewing 
grant proposals for excluding from participating in 
human subject research pregnant women or lac-
tating women as a study population requiring addi-
tional protections. 
SEC. 3. ANNUAL REPORT FROM FDA ON APPROVED NEW 
DRUG APPLICATIONS WITH INFORMATION 
ON PREGNANCY AND LACTATION. 
Not later than 1 year after the date of enactment 
of this Act, and not less than annually for the succeeding 
9 years, the Commissioner of Food and Drugs shall sub-
mit to the appropriate committees of the Congress a re-
port on— 
(1) the number of new drug applications and 
supplements to such applications approved or li-
censed by the Food and Drug Administration under 
section 505(c) of the Federal Food, Drug, and Cos-
metic Act or section 351(a) of the Public Health 
Services Act (42 U.S.C. 262(a)) based on research 
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that included pregnant women or lactating women in 
trials; 
(2) the number of new drug applications and 
supplements to such applications so approved or li-
censed that included data on the excretion of the 
drug in breast milk; 
(3) the number of new drug applications and 
supplements to such applications so approved or li-
censed with required postmarket studies in pregnant 
or breastfeeding women; and 
(4) the number of drugs with respect to which 
a labeling change is made to include new informa-
tion regarding use in pregnant or breastfeeding 
women. 
Æ 
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