Authorizing Legislation: Safe Motherhood Act

I

107TH CONGRESS
2D SESSION

H. R. 4602

To amend the Public Health Service Act and the Federal Food, Drug,
and Cosmetic Act to ensure a safe pregnancy for all women in the
United States, to reduce the rate of maternal morbidity and mortality,
to eliminate racial and ethnic disparities in maternal health outcomes,
to reduce pre-term labor, to examine the impact of pregnancy on the
short and long term health of women, to expand knowledge about the
safety and dosing of drugs to treat pregnant women with chronic conditions and women who become sick during pregnancy, to expand public
health prevention, education and outreach, and to develop improved and
more accurate data collection related to maternal morbidity and mortality.

IN THE HOUSE OF REPRESENTATIVES
APRIL 25, 2002
Mr. DINGELL (for himself and Mrs. LOWEY) introduced the following bill;
which was referred to the Committee on Energy and Commerce

A BILL
To amend the Public Health Service Act and the Federal
Food, Drug, and Cosmetic Act to ensure a safe pregnancy for all women in the United States, to reduce
the rate of maternal morbidity and mortality, to eliminate racial and ethnic disparities in maternal health outcomes, to reduce pre-term labor, to examine the impact
of pregnancy on the short and long term health of
women, to expand knowledge about the safety and dosing
of drugs to treat pregnant women with chronic conditions
and women who become sick during pregnancy, to ex-

2
pand public health prevention, education and outreach,
and to develop improved and more accurate data collection related to maternal morbidity and mortality.
1

Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled,
3

SECTION 1. SHORT TITLE.

4

This Act may be cited as the ‘‘Safe Motherhood Act

5 for Research and Treatment’’ or the ‘‘SMART Mom Act’’.
6

SEC. 2. FINDINGS AND PURPOSES.

7

(a) FINDINGS.—Congress makes the following find-

8 ings:
9

(1) Pregnancy is a natural condition. Approxi-

10

mately 6,000,000 women become pregnant each year

11

and more than 10,000 give birth each day.

12
13

(2) The United States ranks 20th in maternal
mortality out of 49 developed countries.

14

(3) In the United States about 1,000 women

15

will die each year from pregnancy-related illnesses or

16

conditions. Two to 3 lives are lost each day due to

17

pregnancy-related mortality.

18

(4) Racial and ethnic minority women suffer a

19

significantly higher risk of pregnancy-related mor-

20

tality than non-Hispanic white women. African

21

American women are almost 4 times more likely to

22

die from pregnancy-related illnesses or conditions

23

than white women. Hispanic, Asian immigrant, and
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1

American Indian women are twice as likely to die

2

from pregnancy-related illnesses or conditions as

3

their non-Hispanic counterparts.

4

(5) Women between the ages of 35 and 40 are

5

2 to 3 times more likely to experience a pregnancy-

6

related death compared to women between the ages

7

of 20 and 25.

8

(6) There has been no decline in pregnancy-re-

9

lated deaths in the United States over the last 20

10

years. In 1987 the United States set goals as part

11

of Healthy People 2000: National Health Promotion

12

and Disease Prevention Objectives, to reduce mater-

13

nal deaths from 7.5 deaths per 100,000 to 3.3 per

14

100,000 for live births and no more than 5.0 mater-

15

nal deaths per 100,000 births among African Amer-

16

ican women. Again in 2000, as part of Health Peo-

17

ple 2010, new goals have been set. These goals have

18

not been met.

19

(7) In the United States, 30 percent of women,

20

or 1 out of every 3 pregnant women, experience a

21

major medical complication at some point during

22

their pregnancy. The most common complications

23

are miscarriage, ectopic pregnancy, excessive vom-

24

iting, diabetes, hemorrhage, infection, pre-eclampsia,

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1

premature labor, and the need for a surgical (cae-

2

sarean) delivery.

3

(8) Women who are at high-risk, who have a

4

chronic condition, or who do not have access to

5

health care face even more difficult pregnancies, de-

6

liveries, and risk to their long-term health.

7

(9) African American, Hispanic, and older

8

women, have a significantly increased risk of com-

9

plications.

10

(10) Pre-term infants were more than 14 times

11

more likely than infants that were not pre-term to

12

die before their first birthday.

13

(11) There is a lack of knowledge regarding the

14

causes of these complications, as well as effective

15

preventative and therapeutic interventions. Perinatal

16

diseases rank as the second lowest National Institute

17

of Health-funded group of diseases in the whole field

18

of medicine when comparisons take into account dis-

19

ability adjusted life years (DALYs) lost due to each

20

disease.

21

(12) Most drugs women take during pregnancy

22

are necessary to maintain health. However, 80 per-

23

cent of approved drugs lack adequate scientific evi-

24

dence about their use in pregnancy. Only 1 percent

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1

of drugs have been shown in controlled studies to

2

pose no risk to pregnant women.

3

(13) Women under age 35 take an average of

4

3 prescription drugs during pregnancy. For women

5

over the age of 35 the number of prescription drugs

6

increases to 5.

7

(14) Pregnancy is a critical time in a women’s

8

life with far ranging implications for her short- and

9

long-term health and for the health of her family.

10

The United States must devote the resources and

11

have the will of the nation to ensure a safe preg-

12

nancy and good health throughout the lives of Amer-

13

ican women.

14

(b) PURPOSES.—It is the purpose of this Act to—

15

(1) develop a national effort to achieve a

16

healthy and safe pregnancy for all women in the

17

United States;

18
19
20
21
22
23
24

(2) reduce the risk of pregnancy-related deaths
and complications due to pregnancy;
(3) eliminate racial and ethnic disparities in the
rates of maternal mortality and morbidity;
(4) improve the treatment and clinical care of
pregnant women;
(5) reduce pre-term labor;

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1
2
3
4

(6) examine the impact of pregnancy on the
short- and long-term health of women;
(7) work toward an evidence-based standard of
care with respect to pregnant women;

5

(8) expand knowledge about the safety and dos-

6

ing of drugs and devices used to treat pregnant

7

women with chronic conditions and women who be-

8

come sick during pregnancy;

9
10

(9) expand public health prevention, education
and outreach; and

11

(10) develop improved and more accurate data

12

collection relating to maternal morbidity and mor-

13

tality.

19

TITLE I—AMENDMENTS TO THE
PUBLIC HEALTH SERVICE ACT
Subtitle
A—Reducing
Maternal
Morbidity
and
Mortality
Through Coordinated Federal
Action

20

SEC. 101. INTERAGENCY COORDINATING COMMITTEE ON

14
15
16
17
18

21
22

SAFE MOTHERHOOD.

Part P of title III of the Public Health Service Act

23 (42 U.S.C. 280g et seq.) is amended by adding at the end
24 the following:

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1

‘‘SEC. 399O. INTERAGENCY COORDINATING COMMITTEE ON

2
3

SAFE MOTHERHOOD.

‘‘(a)

ESTABLISHMENT.—The

Secretary,

acting

4 through the Director of the Office of Women’s Health,
5 shall establish a committee to be known as the ‘Inter6 agency Coordinating Committee on Safe Motherhood’ (re7 ferred to in this section as the ‘Coordinating Committee’).
8

‘‘(b) COMPOSITION.—The Coordinating Committee

9 shall be composed of—
10

‘‘(1) the Director of the Centers for Disease

11

Control and Prevention (and the heads of such insti-

12

tutes, centers and offices as the Director determines

13

appropriate);

14

‘‘(2) the Director of the National Institutes of

15

Health (and the heads of such institutes, centers

16

and offices as the Director determines appropriate);

17

‘‘(3) the Director of the Health Resources and

18

Services Administration (and the heads of such in-

19

stitutes, centers and offices as the Director deter-

20

mines appropriate);

21

‘‘(4) the Commissioner of Food and Drugs (and

22

the heads of such institutes, centers and offices as

23

the Commissioner determines appropriate);

24

‘‘(5) the Director of the Agency for Healthcare

25

Research and Quality (and the heads of such insti-

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1

tutes, centers and offices as the Director determines

2

appropriate);

3

‘‘(6) the Secretary of Labor (and the heads of

4

such institutes, centers and offices as the Secretary

5

determines appropriate);

6
7

‘‘(7) representatives of other Federal Government agencies that serve women; and

8

‘‘(8) representatives of women’s health care ad-

9

vocacy and grassroots organizations, health care pro-

10

viders including providers of specialty care, and re-

11

searchers to be appointed by the Director of the Of-

12

fice.

13

‘‘(c) ADMINISTRATIVE SUPPORT.—The Secretary

14 shall make available to the Coordinating Committee nec15 essary and appropriate administrative support.
16

‘‘(d) DUTIES.—

17

‘‘(1) EVALUATION.—The Coordinating Com-

18

mittee shall assess health promotion campaigns that

19

are administered by the Federal Government (in-

20

cluding smoking cessation programs, alcohol and

21

substance abuse treatment programs, and domestic

22

violence prevention programs), evaluate the effect

23

that such campaigns have on health during preg-

24

nancy if pregnancy was a focus, and assess whether

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1

such programs may be adapted to emphasize the im-

2

portance of maternal health.

3

‘‘(2) FEDERAL

4

‘‘(A) IN

RESEARCH PLAN.—
GENERAL.—Not

later than 18

5

months after the date of enactment of this sec-

6

tion, the Coordinating Committee shall develop

7

a coordinated Federal research and strategic

8

action plan for safe motherhood.

9

‘‘(B)

CONTENTS.—The

plan

developed

10

under subparagraph (A) shall define the areas

11

of research that are necessary to carry out the

12

purposes of the SMART Mom Act and include

13

recommendations for the implementation and

14

funding of activities under the plan. Such plan

15

shall take into consideration any programs and

16

plans existing on the date of enactment of this

17

section as well as research opportunities that

18

arise during the 5-year period beginning on

19

such date of enactment and shall at a minimum

20

include—

21

‘‘(i) recommendations for research on

22

pregnancy-related conditions;

23

‘‘(ii) recommendations for research on

24

the impact of chronic conditions, physical

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1

impairments, or mental health conditions

2

on pregnant women;

3

‘‘(iii) recommendations for research

4

on medical complications that occur during

5

delivery;

6

‘‘(iv) recommendations for research on

7

post-partum conditions (such as depres-

8

sion, hemorrhage, and fever);

9

‘‘(v) recommendations for research on

10

racial, ethnic, social, behavioral, and eco-

11

nomic factors effecting pregnancy;

12

‘‘(vi) recommendations for research to

13

improve outreach efforts, education pro-

14

grams, and prevention and health pro-

15

motion strategies for pregnant women; and

16

‘‘(vii) a recommended plan and re-

17

search agenda to improve knowledge about

18

the safety of drugs, devices, cosmetics, and

19

food with respect to pregnancy.

20

‘‘(C) REPORT.—Not later than 18 months

21

after the date of enactment of this section, the

22

Coordinating Committee shall prepare and sub-

23

mit to the Secretary and the appropriate com-

24

mittees of Congress, a report concerning the

25

plan developed under this paragraph and the

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1

results of the evaluation conducted under para-

2

graph (1).

3

‘‘(3) KEY

4

‘‘(A)

INDICATORS OF WELL BEING.—

IN

GENERAL.—The

Coordinating

5

Committee, in consultation with the Centers for

6

Disease Control and Prevention, the Director of

7

the National Institute of Child Health and

8

Human Development, the Director of the Agen-

9

cy for Healthcare Research and Quality, and

10

the heads of other relevant Federal agencies,

11

shall determine the key indicators of maternal

12

health and the sources of data to be included in

13

the report under subparagraph (B), and shall

14

update such indicators as new data becomes

15

available.

16

‘‘(B) REPORT.—Not later than October 1,

17

2003, and biannually thereafter, the Coordi-

18

nating Committee shall prepare and submit to

19

the appropriate committees of Congress, a re-

20

port, to be known as ‘America’s Mothers: Key

21

National Indicators of Well Being’ (referred to

22

in this section as the ‘Report’), that contains

23

the indicators of maternal health described in

24

subparagraph (A).

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1

‘‘(C) AVAILABILITY.—The Report shall be

2

made available to the public through the Inter-

3

net website established under paragraph (4).

4

‘‘(4) SAFE

MOTHERHOOD CAMPAIGN.—The

Co-

5

ordinating Committee shall establish and implement

6

a national public education and health promotion

7

campaign on safe motherhood, including developing

8

and maintaining an Internet website as provided for

9

in section 399P, promoting the establishment of

10

community partnerships, supporting community-

11

based programs, promoting the establishment of

12

partnerships with State and local health providers

13

and educators, and promoting the establishment of

14

partnerships with private non-profit organizations.

15

‘‘(e) NONAPPLICABILITY

OF

FACA.—The provisions

16 of the Federal Advisory Committee Act (5 U.S.C. App.)
17 shall not apply to the Coordinating Committee.
18

‘‘(f) AUTHORIZATION

OF

APPROPRIATIONS.—There

19 is authorized to be appropriated, such sums as may be
20 necessary to carry out this section.’’.

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3

Subtitle B—Research and Data Collection to Improve Maternal
Well-Being

4

SEC. 111. EXPAND AND INTENSIFY RESEARCH ACTIVITIES

1
2

5
6

AT THE NATIONAL INSTITUTE OF HEALTH.

(a) PURPOSE.—It is the purpose of this section to

7 require the Director of the National Institutes of Health,
8 acting through the Director of the National Institute of
9 Child Health and Human Development and in collabora10 tion with the Directors of other appropriate Institutes and
11 Offices, to expand and intensify research activities with
12 respect to conditions that lead to pregnancy-related ill13 nesses, injury and death before, during, and after preg14 nancy and to expand research to improve understanding
15 and treatment of pregnant women who have chronic dis16 ease, physical impairment, or mental health conditions.
17

(b) SAFE MOTHERHOOD AS A PRIORITY AREA.—Sub-

18 part 7 of part C of title IV of the Public Health Service
19 Act (42 U.S.C. 285g et seq.) is amended by adding at
20 the end the following:
21
22

‘‘SEC. 452H. SAFE MOTHERHOOD REPORT.

‘‘The Director of the Institute shall annually report

23 to Congress and the public on the extent of the total funds
24 obligated to conduct or support research on safe mother25 hood across the National Institutes of Health, including
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1 the specific support and research awards allocated through
2 the such Institutes.’’.
3

(c) EXPANDED

RESEARCH INTO

PREGNANCY.—Sub-

4 part 7 of part C of title IV of the Public Health Service
5 Act (42 U.S.C. 285g et seq.), as amended by subsection
6 (b), is further amended by adding at the end the following:
7
8
9

‘‘SEC. 452I. EXPANDED RESEARCH ON PREGNANCY.

‘‘(a) CONDITIONS
NANCY.—In

AND

COMPLICATIONS

OF

PREG-

order to improve the understanding of condi-

10 tions and complications related to pregnancy, to lead to
11 better treatments and care for women throughout their
12 pregnancy, and to prevent pregnancy-related illnesses, in13 jury and death whenever possible, the Director of NIH,
14 acting through the Director of the Institute, shall enhance
15 and expand research into the leading causes of pregnancy16 related death and complications of pregnancy.
17
18

‘‘(b) REDUCING PRE-TERM LABOR
ERY.—In

AND

DELIV-

order to reduce the rates of pre-term labor and

19 delivery, the Director of NIH shall expand and intensify
20 research on pre-term labor and delivery.
21

‘‘(c) POST-PARTUM HEALTH CONDITIONS.—The Di-

22 rector of NIH shall expand and enhance research con23 cerning the post-partum health conditions and illness that
24 affect women.

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1
2

‘‘(d) REDUCTIONS
TIES.—The

RACIAL

IN

AND

ETHNIC DISPARI-

Director of NIH shall provide for the conduct

3 of research to investigate the mechanisms contributing to
4 the disparities in maternal and perinatal outcomes of ra5 cial and ethnic populations and immigrant groups.
6

‘‘(e) AUTHORIZATION

OF

APPROPRIATIONS.—There

7 is authorized to be appropriated, such sums as may be
8 necessary to carry out this section.’’.
9
10

(d) IMPROVING
MENT OF

THE

UNDERSTANDING

CHRONIC CONDITIONS

OF

AND

TREAT-

WOMEN DURING

11 PREGNANCY.—Part H of title IV of the Public Health
12 Service Act (42 U.S.C. 289 et seq.) is amended by insert13 ing after section 494A, the following:
14

‘‘SEC. 494B. IMPROVING THE UNDERSTANDING AND TREAT-

15

MENT OF CHRONIC CONDITIONS OF WOMEN

16

DURING PREGNANCY.

17

‘‘(a) IN GENERAL.—The Director of NIH shall ex-

18 pand research concerning the impact of chronic conditions,
19 physical impairments, and mental health problems on the
20 health of women during their pregnancy.
21

‘‘(b) COLLABORATION.—In carrying out subsection

22 (a), the Director of the Institute shall act in collaboration
23 with the Directors of other appropriate Institutes and Of24 fices of the National Institutes of Health.’’.

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1

‘‘(c) AUTHORIZATION

OF

APPROPRIATIONS.—There

2 is authorized to be appropriated, such sums as may be
3 necessary to carry out this section.’’.
4
5

(e) MATERNAL FETAL MEDICINE UNITS NETWORK.—Subpart

7 of part C of title IV of the Public

6 Health Service Act (42 U.S.C. 285g et seq.), as amended
7 by subsection (c), is further amended by adding at the
8 end the following:
9

‘‘SEC. 452J. MATERNAL FETAL MEDICINE UNITS NETWORK.

10

‘‘(a) IN GENERAL.—The Director of the Institute

11 shall establish a Maternal Fetal Medicine Units Network.
12 In carrying out this subsection, the Director may enter
13 into agreements to utilize the existing Maternal Fetal
14 Medicine Units Network.
15

‘‘(b) EXPANSION OF NETWORK.—The Director of the

16 Institute shall, through grants, contracts, or cooperative
17 agreements, expand the Maternal Fetal Medicine Units
18 Network established or utilized under subsection (a) to as19 sist in the implementation of sections 452I and 494B.
20

‘‘(c) AUTHORIZATION

OF

APPROPRIATIONS.—There

21 is authorized to be appropriated, such sums as may be
22 necessary to carry out this section.’’.

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1

SEC. 112. EXPAND AND INTENSIFY RESEARCH ACTIVITIES

2

AT THE CENTERS FOR DISEASE CONTROL

3

AND PREVENTION.

4

(a) REDUCTION

5 ETHNIC

AND

IN

POOR PREGNANCY OUTCOMES

OF

MINORITY WOMEN.—Section 317K of the

6 Public Health Service Act (42 U.S.C. 247b–12) is
7 amended—
8

(1) by redesignating subsection (d) as sub-

9

section (f); and

10

(2) by inserting after subsection (c), the fol-

11

lowing:

12

‘‘(d) REDUCTION

13
14

OF

IN

POOR PREGNANCY OUTCOMES

ETHNIC AND MINORITY WOMEN.—
‘‘(1) IN

GENERAL.—The

Secretary, acting

15

through the Director of the Centers for Disease

16

Control and Prevention, shall award grants to States

17

to support community-based demonstration projects

18

in disease prevention and health promotion to reduce

19

disparities in pregnancy outcomes, with particular

20

emphasis on social, economic, and behavioral health

21

issues (including violence and obesity) affecting ra-

22

cial and ethnic populations and immigrant groups.

23

Where practicable, such demonstration projects shall

24

be based on relevant scientific studies.

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1

‘‘(2) TECHNICAL

ASSISTANCE.—In

carrying out

2

paragraph (1), the Secretary may provide technical

3

assistance to States.’’.

4

(b) PREVENTION RESEARCH CENTERS.—Section

5 317K of the Public Health Service Act (42 U.S.C. 247b–
6 12) is amended by inserting after subsection (d), as added
7 by subsection (a) of this section, the following:
8

‘‘(e) PREVENTION RESEARCH CENTERS.—The Direc-

9 tor of the Centers for Disease Control and Prevention, act10 ing through the National Center for Chronic Disease Pre11 vention and Health Promotion, shall award grants to uni12 versities and other non-profit research institutions and
13 centers to enable such entities to conduct research con14 cerning improving maternal outcomes and eliminating ra15 cial disparities in maternal morbidity and mortality, with
16 special emphasis provided to research concerning the role
17 of stress, violence, discrimination, access, nutrition, obe18 sity and literacy.’’.
19

SEC. 113. IMPROVE QUALITY HEALTH CARE FOR PREG-

20

NANT

21

HEALTHCARE RESEARCH AND QUALITY.

22

WOMEN

THROUGH

AGENCY

FOR

Section 913 of the Public Health Service Act (42

23 U.S.C. 299b–2) is amended by adding at the end the fol24 lowing:
25

‘‘(c) MATERNAL HEALTH CARE.—

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1

‘‘(1) IN

GENERAL.—The

Director shall provide

2

for the conduct of research concerning the quality of

3

maternal health care from a patient-centered per-

4

spective, including—

5

‘‘(A) the type of care that is available and

6

provided prior to, during, and after pregnancy;

7

‘‘(B) an examination of all types of care

8

and interventions, both medical and non-med-

9

ical, as well as barriers women face in gaining

10

access to recommended treatments; and

11

‘‘(C) recommendations for the minimum

12

care needed to be considered as having received

13

quality care.

14

‘‘(2) REPORT.—The results of the research con-

15

ducted under paragraph (1) shall be provided by the

16

Director to Congress as part of the annual report

17

submitted under subsection (b)(2).’’.

19

Subtitle C—Data Collection and
Surveillance

20

SEC. 121. EXPAND AND INTENSIFY DATA COLLECTION AC-

21

TIVITIES AT THE CENTERS FOR DISEASE

22

CONTROL AND PREVENTION.

18

23

Part B of title III of the Public Health Service Act

24 (42 U.S.C. 243 et seq.) is amended by inserting after sec25 tion 317K the following:
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1

‘‘SEC. 317K–1. DATA COLLECTION REGARDING SAFE MOTH-

2
3
4

ERHOOD.

‘‘(a) STANDARD DEFINITIONS
LATED

MORTALITY

AND

FOR

PREGNANCY-RE-

MORBIDITY.—The Secretary,

5 acting through the Director of the Centers for Disease
6 Control and Prevention and in cooperation with State offi7 cials, professional medical experts, medical organizations,
8 and health care advocacy groups, shall develop a standard
9 definition of ‘maternal mortality’ and ‘maternal mor10 bidity’.
11

‘‘(b) GRANTS

FOR

SURVEILLANCE

OF

PREGNANCY-

12 RELATED MORTALITY AND MORBIDITY DATA.—
13

‘‘(1) IN

GENERAL.—The

Secretary, acting

14

through the Director of the Centers for Disease

15

Control and Prevention, shall establish a program to

16

award grants to States, counties, and cities for the

17

development of surveillance systems, that use the

18

standard definitions established under subsection

19

(a), to gather data on maternal mortality and mater-

20

nal morbidity.

21

‘‘(2) ELIGIBILITY.—To be eligible to receive a

22

grant under paragraph (1), a State, county, or city

23

shall—

24

‘‘(A) prepare and submit to the Secretary

25

an application, at such time, in such manner,

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1

and containing such information as the Sec-

2

retary may require;

3

‘‘(B) provide an assurance that the appli-

4

cant will work with the Centers for Disease

5

Control and Prevention to adopt standard pro-

6

cedures for the identification, collection, and

7

analysis of the data that is to be collected under

8

the grant; and

9

‘‘(C) provide an assurance that the appli-

10

cant will contribute $1 (in cash or in kind) to

11

activities under the grant for every $4 provided

12

by the Federal Government.

13

‘‘(3) TECHNICAL

ASSISTANCE.—The

Centers

14

for Disease Control and Prevention shall provide

15

technical assistance to grantees under this sub-

16

section.

17

‘‘(4) INCORPORATION

OF DATA INTO REPORT.—

18

Where determined appropriate by the Secretary,

19

data collected by the surveillance systems established

20

under this subsection shall be incorporated into the

21

report submitted under section 399O(d)(3)(B).

22

‘‘(c) PREVALENCE OF PRE-TERM LABOR AND DELIV-

23

ERY.—The

Secretary, acting through the Director of the

24 Centers for Disease Control and Prevention, shall work
25 with States and other entities to improve knowledge re•HR 4602 IH

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1 garding the incidence and prevalence of symptoms and
2 risk factors for pre-term births.
3

‘‘(d) AUTHORIZATION

OF

APPROPRIATIONS.—There

4 is authorized to be appropriated, such sums as may be
5 necessary to carry out this section.’’.
6

SEC. 122. STUDY ON EFFECTS OF PREGNANCY ON WOMEN.

7

Section 1004 of the Children’s Health Act of 2000

8 (42 U.S.C. 285g note) is amended—
9
10
11

(1) by redesignating subsections (d) and (e) as
subsections (e) and (f), respectively; and
(2) by inserting after subsection (c), the fol-

12

lowing:

13

‘‘(d) STUDY

ON

EFFECTS

OF

PREGNANCY

ON

14 WOMEN.—As part of the study conducted under this sec15 tion, the Director of the National Institute of Child Health
16 and Human Development, in collaboration with the Direc17 tor of the Centers for Disease Control and Prevention, the
18 Commission on Food and Drugs, and other appropriate
19 Federal officials, shall plan, develop, and implement a pro20 spective cohort study of mothers to determine the effects
21 of pregnancy on the health of women. Such study shall
22 evaluate—
23
24

‘‘(A) the effects of pregnancy on women’s
health;

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1

‘‘(B) the effects of both preexisting and

2

chronic conditions, physical impairments, and

3

mental health problems related to pregnancy;

4

‘‘(C) the impact of stress and anxiety; and

5

‘‘(D) environmental health factors that in-

6

fluence both the mother’s health and that of her

7

child.’’.

8
9
10
11

Subtitle D—Public Education and
Outreach
SEC. 131. PURPOSE.

It is the purpose of this subtitle to address the need

12 for providing women with accurate and up-to-date infor13 mation through a 21st century public education and out14 reach Campaign for Safe Motherhood that shall raise the
15 public awareness of the issues related to safe motherhood,
16 including—
17
18

(1) preventing pregnancy-related illnesses, injury, and death; and

19

(2) providing women and other interest parties

20

with the tools necessary to achieve safe and healthy

21

pregnancies.

22
23

SEC. 132. SAFE MOTHERHOOD CAMPAIGN.

Part P of title III of the Public Health Service Act

24 (42 U.S.C. 280g et seq.), as amended by section 101, is
25 further amended by adding at the end the following:
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1
2

‘‘SEC. 399P. SAFE MOTHERHOOD CAMPAIGN.

‘‘(a)

ESTABLISHMENT.—The

Secretary,

acting

3 through the Director of the Office of Women’s Health and
4 the Interagency Coordinating Committee on Safe Mother5 hood (referred to in this section as the ‘Coordinating Com6 mittee’) established under section 399O, shall develop and
7 implement a national public education and health pro8 motion campaign to be known as the Safe Motherhood
9 Campaign (referred to in this section as the ‘Campaign’).
10

‘‘(b) ELEMENTS

OF

CAMPAIGN.—The Campaign

11 shall at a minimum include the following:
12
13
14

‘‘(1) WEBSITE.—An Internet website to be established in accordance with subsection (c).
‘‘(2) COMMUNITY

PARTNERSHIPS.—The

provi-

15

sion of support for community-based programs to

16

provide outreach, education, information and health

17

promotion services and information to give women

18

the tools they need to achieve a safe and healthy

19

pregnancy.

20

‘‘(3) STATE

AND LOCAL PARTNERSHIPS.—The

21

facilitation of consultations with State and local pub-

22

lic health officials to gain access to the broadest

23

number of women in an effort to provide outreach

24

and education assistance and information to help

25

women succeed in having a safe and healthy preg-

26

nancy.
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1

‘‘(4) SPECIAL

POPULATIONS.—The

implementa-

2

tion of procedures to ensure that activities under the

3

Campaign are accessible to low-literate, non-English

4

speaking, and nonnative immigrant communities

5

where determined appropriate by the Secretary.

6

‘‘(c) INTERNET WEBSITE.—

7

‘‘(1) ESTABLISHMENT.—The Secretary, acting

8

through the Office of Women’s Health and the Co-

9

ordinating Committee, shall develop and maintain a

10

single Internet website to provide pregnant women,

11

and research and health practitioners with the most

12

up-to-date and accurate information on pregnancy,

13

in a manner designed to carry out the purpose de-

14

scribed in paragraph (2).

15

‘‘(2) PURPOSE.—It is the purpose of the

16

website established under paragraph (1) to consoli-

17

date information, research, and data related to preg-

18

nancy (prenatal, intrapartum, and postpartum) to-

19

gether in one place and to provide links for women

20

to other critical websites (Federal agencies, commu-

21

nity health programs, State and tribal health pro-

22

grams, and self-help professional and advocacy orga-

23

nizations).

24

‘‘(3) ADDRESS.—The Secretary shall ensure

25

that the uniform resource locator for the website es-

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1

tablished

2

www.pregnancy.gov. If such locator is not available,

3

the Secretary shall select another similar locator.

4

under

‘‘(4)

paragraph

CONTENTS.—The

website

(1)

is

established

5

under paragraph (1) shall, at a minimum, contain—

6

‘‘(A) educational materials for how to suc-

7

ceed in having the safest pregnancy possible, in-

8

cluding a description of chronic conditions,

9

pregnancy-related illnesses, and other health

10

problems that could pose risks to the mother or

11

fetus;

12

‘‘(B) information concerning the safety

13

and risk of prescription and over-the-counter

14

medications and other products that women

15

might use during pregnancy;

16
17

‘‘(C) information concerning standards for
clinical care throughout pregnancy;

18

‘‘(D) information on trends in labor inter-

19

vention, such as induction, epidural, and cae-

20

sarean sections, and alternative approaches;

21

‘‘(E) information concerning the issue of

22

domestic violence during pregnancy, including

23

how women can obtain assistance;

24
25

‘‘(F) information concerning infertility and
maternal health; and

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1

‘‘(G) information concerning pregnancy-re-

2

lated workplace laws and policies, such as the

3

Family and Medical Leave Act of 1993.

4

‘‘(5) APPROPRIATE

FORM OF INFORMATION.—

5

The information contained on the website estab-

6

lished under paragraph (1) shall be maintained in a

7

culturally sensitive and appropriate form.

8

‘‘(d) AUTHORIZATION

OF

APPROPRIATIONS.—There

9 is authorized to be appropriated, such sums as may be
10 necessary to carry out this section.’’.

12

TITLE II—PREGNANT AND
LACTATING WOMEN

13

SEC. 201. AMENDMENTS TO FEDERAL FOOD, DRUG, AND

11

14
15

COSMETIC ACT.

(a) AMENDMENT

TO

CHAPTER V.—Chapter V of the

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351
17 et seq.) is amended by adding at the end the following:
18

‘‘SEC. 564. SAFE DRUGS AND DEVICES FOR PREGNANT AND

19
20

LACTATING WOMEN.

‘‘(a) IMPROVING

21 DRUGS

AND

THE

QUALITY

OF INFORMATION ON

BIOLOGICAL PRODUCTS

FOR

WOMEN WHO

22 ARE PREGNANT OR LACTATING.—
23
24

‘‘(1) MARKETED

DRUGS

FOR

TIONAL INFORMATION IS NEEDED.—

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WHICH

ADDI-

28
1

‘‘(A) IDENTIFYING

DRUGS TO BE STUD-

2

IED.—The

3

tor of the National Institutes of Health and in

4

consultation with the Commissioner of Food

5

and Drugs and experts in maternal and fetal

6

health, shall—

Secretary, acting through the Direc-

7

‘‘(i) identify marketed drugs and bio-

8

logical products that were not approved or

9

licensed based on studies in pregnant

10

women for which studies are needed—

11

‘‘(I) to establish appropriate dos-

12

ing for women who are pregnant or

13

lactating; and

14

‘‘(II) to investigate the marketed

15

drugs and biological products’ safe

16

use for pregnant women and fetuses

17

through the use of pregnancy reg-

18

istries and pharmacoepidemiological

19

databases; and

20

‘‘(ii) design protocols for the needed

21

studies described in clause (i).

22

‘‘(B) STUDYING

MARKETED DRUGS.—The

23

Director of the National Institutes of Health

24

shall award grants, enter into contracts, or use

25

other appropriate mechanisms to aid in prompt-

•HR 4602 IH

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1

ly completing the studies designed under sub-

2

paragraph (A), as the National Institutes of

3

Health’s resources allow.

4

‘‘(2) POSTMARKETING

STUDIES.—As

a condi-

5

tion of approval of an application submitted under

6

section 505(b)(1) or of a biologics license application

7

under section 351 of the Public Health Service Act

8

(42 U.S.C. 262), the Secretary may require that the

9

holder of the application conduct postmarketing

10

studies, to be completed and submitted to the Sec-

11

retary by a date specified by the Secretary, to—

12

‘‘(A) establish dosing recommendations for

13

such drug or biological product for women who

14

are pregnant or lactating; and

15

‘‘(B) investigate the safe use of such drug

16

or biological product for pregnant women and

17

fetuses through the use of pregnancy registries

18

and pharmacoepidemiological databases.

19

‘‘(3)

20

PREGNANCY

REGISTRIES

AND

PHARMACOEPIDEMIOLOGICAL DATABASES.—

21

‘‘(A) REGISTRIES.—The Secretary shall

22

issue guidances on the use and evaluation of

23

data from pregnancy registries, including data

24

from centralized registries for drugs and bio-

25

logical products.

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1

‘‘(B) DATABASES.—

2

‘‘(i) ESTABLISHMENT.—The Secretary

3

shall establish or award grants, enter into

4

contracts and cooperative agreements, and

5

use other appropriate mechanisms to pro-

6

vide for pharmacoepidemiological databases

7

(including a teratogen surveillance system)

8

to study safety issues related to drugs and

9

biological products, including safety issues

10

for pregnant women and fetuses.

11

‘‘(ii) STUDY

AND USE OF DATA.—The

12

Secretary shall hold workshops and issue

13

guidances on how to study and use the

14

data from the pharmacoepidemiological

15

databases established or provided for under

16

clause (i).

17

‘‘(4) CLARIFICATION

18

CLUSIVITY INTERACTIONS.—A

19

involved in any study conducted under this sub-

20

section shall not be considered to be a new clinical

21

investigation for purposes of clauses (iii) and (iv) of

22

section 505(j)(5(D).

23

‘‘(b) IMPROVING COMMUNICATION

24

TO

PREGNANT

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AND

REGARDING MARKET EX-

clinical investigation

OF

LACTATING WOMEN

INFORMATION
AND

THEIR

31
1 HEALTH CARE PROVIDERS THROUGH DRUG LABEL2
3

ING.—

‘‘(1) REGULATIONS.—

4

‘‘(A) PROPOSED

REGULATION.—Not

later

5

than 6 months after the date of enactment of

6

this section, the Secretary shall promulgate a

7

proposed regulation requiring enhanced commu-

8

nication of safety and dosage information for

9

women who are pregnant or lactating in the la-

10

beling of drugs, including drugs licensed under

11

section 351 of the Public Health Service Act

12

(42 U.S.C. 262).

13

‘‘(B) FINAL

RULE.—Not

later than 2

14

years after the date of enactment of this sec-

15

tion, the Secretary shall promulgate a final reg-

16

ulation requiring enhanced communication of

17

safety and dosage information for women who

18

are pregnant or lactating in the labeling of

19

drugs, including drugs licensed under section

20

351 of the Public Health Service Act (42

21

U.S.C. 262).

22

‘‘(2) BIENNIAL

REVIEW OF CERTAIN DRUGS.—

23

Not later than 32 months after the date of enact-

24

ment of this section, and biennially thereafter, each

25

person who holds an approved application for a drug

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1

under section 505(b) that was not approved based

2

on studies of pregnant women or who holds an ap-

3

proved biologics license application for a drug under

4

section 351 of the Public Health Service Act (42

5

U.S.C. 262) that was not licensed based on studies

6

of pregnant women, shall—

7

‘‘(A) review any newly available data or in-

8

formation for such drug, including data or in-

9

formation from the studies completed under

10

subsection (a), to determine whether such data

11

or information, and all other relevant data and

12

information, warrants a labeling change for

13

women who are pregnant or lactating; and

14

‘‘(B) submit to the Secretary—

15

‘‘(i) a supplement to the holders’ new

16

drug application or biologics license appli-

17

cation that includes—

18

‘‘(I) a summary of the data or

19

information reviewed under subpara-

20

graph (A);

21

‘‘(II) an analysis of why such

22

data or information warrants a label-

23

ing change for women who are preg-

24

nant or lactating;

•HR 4602 IH

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1

‘‘(III) a proposal for the labeling

2

change; and

3

‘‘(IV) a certification that the re-

4

view, summary, and analysis is com-

5

plete and accurate; or

6

‘‘(ii) a letter that includes—

7

‘‘(I) a summary of the data or

8

information, if any, reviewed under

9

subparagraph (A);

10

‘‘(II) an analysis of why such

11

data or information does not warrant

12

a labeling change for women who are

13

pregnant or lactating; and

14

‘‘(III) a certification that the re-

15

view, summary, and analysis is com-

16

plete and accurate.

17

‘‘(3) BIENNIAL

SUBMISSIONS.—In

the regula-

18

tions promulgated under paragraph (1), the Sec-

19

retary shall prescribe requirements for—

20
21

‘‘(A) the summary of data or information
reviewed under paragraph (2)(A); and

22

‘‘(B) the analysis of why such data or in-

23

formation does or does not warrant a labeling

24

change required to be submitted to the Sec-

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1

retary in a supplement or in a letter under

2

paragraph (2)(B).

3

‘‘(4) PERIODIC

REVIEW OF DRUGS.—

4

‘‘(A) PRIORITY.—Not later than 2 years

5

after the date of enactment of this section, the

6

Secretary shall prioritize marketed drugs that

7

were not approved or licensed based on studies

8

in pregnant women, considering—

9

‘‘(i) how widely such drugs are used

10

by women who are pregnant or lactating;

11

‘‘(ii) whether new information avail-

12

able about such drugs may warrant a la-

13

beling change for such women; and

14

‘‘(iii) which of such drugs have label-

15

ing for such women that is most in need

16

of revision.

17

‘‘(B) REGULATIONS

18

‘‘(i) INITIAL

AND ORDERS.—

REGULATIONS AND OR-

19

DERS.—Based

20

drugs under subparagraph (A), the Sec-

21

retary shall, as resources allow—

on the prioritization of

22

‘‘(I) promulgate regulations for

23

such drugs that meet the conditions

24

contained in any applicable mono-

25

graph to revise safety and dosage in-

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1

formation required in labeling for

2

women who are pregnant or lactating;

3

and

4

‘‘(II) issue orders for other such

5

drugs to require revised safety and

6

dosage information required in label-

7

ing for women who are pregnant or

8

lactating.

9

‘‘(ii) SUBSEQUENT

REGULATIONS AND

10

ORDERS.—The

11

review new data or information as it be-

12

comes available on the drugs described in

13

subparagraph (A), and shall promulgate

14

regulations or issue orders, as appropriate,

15

to revise safety and dosage information re-

16

quired in labeling for such drugs for

17

women who are pregnant or lactating.

18

Secretary shall periodically

‘‘(c) IMPROVING COMMUNICATION AND INFORMATION

19 ABOUT FETAL RISK FROM DEVICES.—
20
21

‘‘(1) RESEARCH

ON MATERIALS USED IN DE-

VICES.—

22

‘‘(A) IDENTIFYING

MATERIALS

TO

BE

23

STUDIED.—The

24

Director of the National Institutes of Health

•HR 4602 IH

Secretary, acting through the

36
1

and in consultation with the Commissioner of

2

Food and Drugs, shall—

3

‘‘(i) periodically review all available

4

data and information about the safety for

5

persons and fetuses of materials used in

6

devices that may come into contact with,

7

or be absorbed into, the body;

8

‘‘(ii) identify materials for which addi-

9

tional data or information is needed to as-

10

sess the safety for persons and fetuses of

11

such materials; and

12

‘‘(iii) design protocols for studies to

13

collect data or information described in

14

clause (ii).

15

‘‘(B) STUDYING

DEVICE MATERIALS.—The

16

Director of the National Institutes of Health

17

shall award grants, enter into contracts, or use

18

other appropriate mechanisms to aid in prompt-

19

ly completing the studies designed under sub-

20

paragraph (A), as the National Institutes of

21

Health’s resources allow.

22

‘‘(C) SAFETY

STUDIES.—The

Secretary

23

may require a person that manufactures a de-

24

vice that bears or contains a material for which

25

the Secretary has designed studies under sub-

•HR 4602 IH

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1

paragraph (A), to complete and submit such

2

studies to the Secretary, by a date specified by

3

the Secretary.

4

‘‘(2) REVIEW

5

BELING.—Considering

6

mation about the safety for persons and fetuses of

7

a material that may come into contact with, or be

8

absorbed into, the body when used in a device, in-

9

cluding data and information from studies conducted

10

OF DEVICE MATERIAL AND LA-

all available data and infor-

under paragraph (1), the Secretary shall—

11

‘‘(A) require appropriate statements dis-

12

closing any risks to persons or fetuses from the

13

material in the labeling of a device that bears

14

or contains such material; or

15

‘‘(B) if use of the material in a device pre-

16

sents an unreasonable and substantial risk of

17

illness or injury to persons or fetuses, ban the

18

use of such material in such device.

19

‘‘(d) LIMITATIONS

20

SURE

21

ING.—In

ON

PROMPT REVISION

INJUNCTIVE RELIEF TO EN-

OF

DRUG

AND

DEVICE LABEL-

an action under section 302 with respect to a

22 drug or a device deemed to be misbranded under section
23 502(k) or section 502(l), such misbranding shall not be
24 the sole basis for any judicial order that requires a person

•HR 4602 IH

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1 to cease the manufacturing, distribution, or sale of such
2 drug or device.
3

‘‘(e) OUTREACH

AND

EDUCATION.—The Secretary

4 shall expand the Women’s Health: Take Time to Care pro5 gram or establish a new program that is directed at—
6

‘‘(1) women who are pregnant or lactating to

7

inform such women about the safety issues involved

8

in taking prescription and over-the-counter drugs,

9

and using medical devices, while such women are

10

pregnant or breast feeding; and

11

‘‘(2) health care providers and the public to

12

provide information about the safety issues involved

13

when women, who are pregnant or breast feeding,

14

take prescription and over-the-counter drugs or use

15

medical devices.

16

‘‘(f) AUTHORIZATION

OF

APPROPRIATIONS.—There

17 are authorized to be appropriated to carry out this section,
18 such sums as are necessary.’’.
19
20

(b) AMENDMENT
VICES.—Section

TO

ADULTERATED DRUGS

AND

DE -

501(g) of the Federal Food, Drug, and

21 Cosmetic Act (21 U.S.C. 351(g)) is amended by striking
22 ‘‘device’’ and inserting ‘‘device or it is a device that bears
23 or contains a material whose use in such a device has been
24 banned under section 564(c)(2)(B)’’.

•HR 4602 IH

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1
2

(c) AMENDMENT
VICES.—Section

TO

MISBRANDED DRUGS

AND

DE -

502 of the Federal Food, Drug, and Cos-

3 metic Act (21 U.S.C. 352) is amended by inserting after
4 subsection (j) the following:
5

‘‘(k)(1) If it is a drug; and—

6

‘‘(2)(A) a study required under section 564(a)(2)

7 with respect to such drug is not completed and submitted
8 to the Secretary by the date specified by the Secretary;
9

‘‘(B) a supplement or letter required to be submitted

10 to the Secretary under section 564(b)(2)(B) with respect
11 to such drug is not submitted to the Secretary;
12

‘‘(C) a supplement or letter required to be submitted

13 to the Secretary under section 564(b)(2)(B) with respect
14 to such drug does not include an adequate summary or
15 analysis of relevant information or data; or
16

‘‘(D) its labeling does not include safety or dosage

17 information for pregnant or lactating women required by
18 the Secretary by regulation or order under section
19 564(b)(4)(B).
20

‘‘(l) If it is a device and its labeling does not include

21 statements required by the Secretary under section
22 564(c)(2)(A).’’.
23

(d) AMENDMENT

TO

CIVIL PENALTIES.—Section

24 307(a) of the Federal Food, Drug, and Cosmetic Act (21
25 U.S.C. 335b(a)) is amended—
•HR 4602 IH

40
1

(1) in paragraph (6)(B), by striking ‘‘or’’; and

2

(2) by inserting after paragraph (7) the fol-

3

lowing:

4

‘‘(8) has failed to complete and submit to the

5

Secretary, by the date specified by the Secretary, a

6

study required by the Secretary under section

7

564(a)(2);

8

‘‘(9) has failed to submit to the Secretary a

9

supplement or letter required to be submitted to the

10

Secretary under section 564(b)(2)(B);

11

‘‘(10) has failed to include an adequate sum-

12

mary or analysis of relevant information or data in

13

a supplement or letter required to be submitted to

14

the Secretary under section 564(b)(2)(B);

15

‘‘(11) has distributed in interstate commerce a

16

drug whose labeling does not include safety or dos-

17

age information for pregnant or lactating women re-

18

quired by the Secretary by regulation or order under

19

section 564(b)(4)(B);

20

‘‘(12) has failed to complete and submit to the

21

Secretary, by the date specified by the Secretary, a

22

study required under section 564(c)(1)(C);

23

‘‘(13) has distributed in interstate commerce a

24

device whose labeling does not include statements re-

•HR 4602 IH

41
1

quired by the Secretary under section 564(c)(2)(A);

2

or

3

‘‘(14) has distributed in interstate commerce a

4

device that bears or contains a material whose use

5

in such device has been banned under section

6

564(c)(2)(B).’’.

Æ

•HR 4602 IH