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 condi-
tions 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 mor-
tality.
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 preg-
nancy for all women in the United States, to reduce
the rate of maternal morbidity and mortality, to elimi-
nate racial and ethnic disparities in maternal health out-
comes, 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-
pand public health prevention, education and outreach,
and to develop improved and more accurate data collec-
tion related to maternal morbidity and mortality.
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 Motherhood Act
for Research and Treatment’’ or the ‘‘SMART Mom Act’’.
SEC. 2. FINDINGS AND PURPOSES.
(a) FINDINGS.—Congress makes the following find-
ings:
(1) Pregnancy is a natural condition. Approxi-
mately 6,000,000 women become pregnant each year
and more than 10,000 give birth each day.
(2) The United States ranks 20th in maternal
mortality out of 49 developed countries.
(3) In the United States about 1,000 women
will die each year from pregnancy-related illnesses or
conditions. Two to 3 lives are lost each day due to
pregnancy-related mortality.
(4) Racial and ethnic minority women suffer a
significantly higher risk of pregnancy-related mor-
tality than non-Hispanic white women. African
American women are almost 4 times more likely to
die from pregnancy-related illnesses or conditions
than white women. Hispanic, Asian immigrant, and
American Indian women are twice as likely to die
from pregnancy-related illnesses or conditions as
their non-Hispanic counterparts.
(5) Women between the ages of 35 and 40 are
2 to 3 times more likely to experience a pregnancy-
related death compared to women between the ages
of 20 and 25.
(6) There has been no decline in pregnancy-re-
lated deaths in the United States over the last 20
years. In 1987 the United States set goals as part
of Healthy People 2000: National Health Promotion
and Disease Prevention Objectives, to reduce mater-
nal deaths from 7.5 deaths per 100,000 to 3.3 per
100,000 for live births and no more than 5.0 mater-
nal deaths per 100,000 births among African Amer-
ican women. Again in 2000, as part of Health Peo-
ple 2010, new goals have been set. These goals have
not been met.
(7) In the United States, 30 percent of women,
or 1 out of every 3 pregnant women, experience a
major medical complication at some point during
their pregnancy. The most common complications
are miscarriage, ectopic pregnancy, excessive vom-
iting, diabetes, hemorrhage, infection, pre-eclampsia,
premature labor, and the need for a surgical (cae-
sarean) delivery.
(8) Women who are at high-risk, who have a
chronic condition, or who do not have access to
health care face even more difficult pregnancies, de-
liveries, and risk to their long-term health.
(9) African American, Hispanic, and older
women, have a significantly increased risk of com-
plications.
(10) Pre-term infants were more than 14 times
more likely than infants that were not pre-term to
die before their first birthday.
(11) There is a lack of knowledge regarding the
causes of these complications, as well as effective
preventative and therapeutic interventions. Perinatal
diseases rank as the second lowest National Institute
of Health-funded group of diseases in the whole field
of medicine when comparisons take into account dis-
ability adjusted life years (DALYs) lost due to each
disease.
(12) Most drugs women take during pregnancy
are necessary to maintain health. However, 80 per-
cent of approved drugs lack adequate scientific evi-
dence about their use in pregnancy. Only 1 percent
of drugs have been shown in controlled studies to
pose no risk to pregnant women.
(13) Women under age 35 take an average of
3 prescription drugs during pregnancy. For women
over the age of 35 the number of prescription drugs
increases to 5.
(14) Pregnancy is a critical time in a women’s
life with far ranging implications for her short- and
long-term health and for the health of her family.
The United States must devote the resources and
have the will of the nation to ensure a safe preg-
nancy and good health throughout the lives of Amer-
ican women.
(b) PURPOSES.—It is the purpose of this Act to—
(1) develop a national effort to achieve a
healthy and safe pregnancy for all women in the
United States;
(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;
(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;
(8) expand knowledge about the safety and dos-
ing of drugs and devices used to treat pregnant
women with chronic conditions and women who be-
come sick during pregnancy;
(9) expand public health prevention, education
and outreach; and
(10) develop improved and more accurate data
collection relating to maternal morbidity and mor-
tality.
TITLE I—AMENDMENTS TO THE
PUBLIC HEALTH SERVICE ACT
Subtitle 
A—Reducing 
Maternal
Morbidity 
and 
Mortality
Through Coordinated Federal
Action
SEC. 101. INTERAGENCY COORDINATING COMMITTEE ON
SAFE MOTHERHOOD.
Part P of title III of the Public Health Service Act
(42 U.S.C. 280g et seq.) is amended by adding at the end
the following:
‘‘SEC. 399O. INTERAGENCY COORDINATING COMMITTEE ON
SAFE MOTHERHOOD.
‘‘(a) 
ESTABLISHMENT.—The 
Secretary, 
acting
through the Director of the Office of Women’s Health,
shall establish a committee to be known as the ‘Inter-
agency Coordinating Committee on Safe Motherhood’ (re-
ferred to in this section as the ‘Coordinating Committee’).
‘‘(b) COMPOSITION.—The Coordinating Committee
shall be composed of—
‘‘(1) the Director of the Centers for Disease
Control and Prevention (and the heads of such insti-
tutes, centers and offices as the Director determines
appropriate);
‘‘(2) the Director of the National Institutes of
Health (and the heads of such institutes, centers
and offices as the Director determines appropriate);
‘‘(3) the Director of the Health Resources and
Services Administration (and the heads of such in-
stitutes, centers and offices as the Director deter-
mines appropriate);
‘‘(4) the Commissioner of Food and Drugs (and
the heads of such institutes, centers and offices as
the Commissioner determines appropriate);
‘‘(5) the Director of the Agency for Healthcare
Research and Quality (and the heads of such insti-
tutes, centers and offices as the Director determines
appropriate);
‘‘(6) the Secretary of Labor (and the heads of
such institutes, centers and offices as the Secretary
determines appropriate);
‘‘(7) representatives of other Federal Govern-
ment agencies that serve women; and
‘‘(8) representatives of women’s health care ad-
vocacy and grassroots organizations, health care pro-
viders including providers of specialty care, and re-
searchers to be appointed by the Director of the Of-
fice.
‘‘(c) ADMINISTRATIVE
SUPPORT.—The Secretary
shall make available to the Coordinating Committee nec-
essary and appropriate administrative support.
‘‘(d) DUTIES.—
‘‘(1) EVALUATION.—The Coordinating Com-
mittee shall assess health promotion campaigns that
are administered by the Federal Government (in-
cluding smoking cessation programs, alcohol and
substance abuse treatment programs, and domestic
violence prevention programs), evaluate the effect
that such campaigns have on health during preg-
nancy if pregnancy was a focus, and assess whether
such programs may be adapted to emphasize the im-
portance of maternal health.
‘‘(2) FEDERAL RESEARCH PLAN.—
‘‘(A) IN
GENERAL.—Not later than 18
months after the date of enactment of this sec-
tion, the Coordinating Committee shall develop
a coordinated Federal research and strategic
action plan for safe motherhood.
‘‘(B) CONTENTS.—The plan developed
under subparagraph (A) shall define the areas
of research that are necessary to carry out the
purposes of the SMART Mom Act and include
recommendations for the implementation and
funding of activities under the plan. Such plan
shall take into consideration any programs and
plans existing on the date of enactment of this
section as well as research opportunities that
arise during the 5-year period beginning on
such date of enactment and shall at a minimum
include—
‘‘(i) recommendations for research on
pregnancy-related conditions;
‘‘(ii) recommendations for research on
the impact of chronic conditions, physical
impairments, or mental health conditions
on pregnant women;
‘‘(iii) recommendations for research
on medical complications that occur during
delivery;
‘‘(iv) recommendations for research on
post-partum conditions (such as depres-
sion, hemorrhage, and fever);
‘‘(v) recommendations for research on
racial, ethnic, social, behavioral, and eco-
nomic factors effecting pregnancy;
‘‘(vi) recommendations for research to
improve outreach efforts, education pro-
grams, and prevention and health pro-
motion strategies for pregnant women; and
‘‘(vii) a recommended plan and re-
search agenda to improve knowledge about
the safety of drugs, devices, cosmetics, and
food with respect to pregnancy.
‘‘(C) REPORT.—Not later than 18 months
after the date of enactment of this section, the
Coordinating Committee shall prepare and sub-
mit to the Secretary and the appropriate com-
mittees of Congress, a report concerning the
plan developed under this paragraph and the
results of the evaluation conducted under para-
graph (1).
‘‘(3) KEY INDICATORS OF WELL BEING.—
‘‘(A) IN
GENERAL.—The Coordinating
Committee, in consultation with the Centers for
Disease Control and Prevention, the Director of
the National Institute of Child Health and
Human Development, the Director of the Agen-
cy for Healthcare Research and Quality, and
the heads of other relevant Federal agencies,
shall determine the key indicators of maternal
health and the sources of data to be included in
the report under subparagraph (B), and shall
update such indicators as new data becomes
available.
‘‘(B) REPORT.—Not later than October 1,
2003, and biannually thereafter, the Coordi-
nating Committee shall prepare and submit to
the appropriate committees of Congress, a re-
port, to be known as ‘America’s Mothers: Key
National Indicators of Well Being’ (referred to
in this section as the ‘Report’), that contains
the indicators of maternal health described in
subparagraph (A).
‘‘(C) AVAILABILITY.—The Report shall be
made available to the public through the Inter-
net website established under paragraph (4).
‘‘(4) SAFE MOTHERHOOD CAMPAIGN.—The Co-
ordinating Committee shall establish and implement
a national public education and health promotion
campaign on safe motherhood, including developing
and maintaining an Internet website as provided for
in section 399P, promoting the establishment of
community partnerships, supporting community-
based programs, promoting the establishment of
partnerships with State and local health providers
and educators, and promoting the establishment of
partnerships with private non-profit organizations.
‘‘(e) NONAPPLICABILITY OF FACA.—The provisions
of the Federal Advisory Committee Act (5 U.S.C. App.)
shall not apply to the Coordinating Committee.
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There
is authorized to be appropriated, such sums as may be
necessary to carry out this section.’’.
Subtitle B—Research and Data Col-
lection 
to 
Improve 
Maternal
Well-Being
SEC. 111. EXPAND AND INTENSIFY RESEARCH ACTIVITIES
AT THE NATIONAL INSTITUTE OF HEALTH.
(a) PURPOSE.—It is the purpose of this section to
require the Director of the National Institutes of Health,
acting through the Director of the National Institute of
Child Health and Human Development and in collabora-
tion with the Directors of other appropriate Institutes and
Offices, to expand and intensify research activities with
respect to conditions that lead to pregnancy-related ill-
nesses, injury and death before, during, and after preg-
nancy and to expand research to improve understanding
and treatment of pregnant women who have chronic dis-
ease, physical impairment, or mental health conditions.
(b) SAFE MOTHERHOOD AS A PRIORITY AREA.—Sub-
part 7 of part C of title IV of the Public Health Service
Act (42 U.S.C. 285g et seq.) is amended by adding at
the end the following:
‘‘SEC. 452H. SAFE MOTHERHOOD REPORT.
‘‘The Director of the Institute shall annually report
to Congress and the public on the extent of the total funds
obligated to conduct or support research on safe mother-
hood across the National Institutes of Health, including
the specific support and research awards allocated through
the such Institutes.’’.
(c) EXPANDED RESEARCH INTO PREGNANCY.—Sub-
part 7 of part C of title IV of the Public Health Service
Act (42 U.S.C. 285g et seq.), as amended by subsection
(b), is further amended by adding at the end the following:
‘‘SEC. 452I. EXPANDED RESEARCH ON PREGNANCY.
‘‘(a) CONDITIONS AND COMPLICATIONS OF PREG-
NANCY.—In order to improve the understanding of condi-
tions and complications related to pregnancy, to lead to
better treatments and care for women throughout their
pregnancy, and to prevent pregnancy-related illnesses, in-
jury and death whenever possible, the Director of NIH,
acting through the Director of the Institute, shall enhance
and expand research into the leading causes of pregnancy-
related death and complications of pregnancy.
‘‘(b) REDUCING PRE-TERM LABOR
AND DELIV-
ERY.—In order to reduce the rates of pre-term labor and
delivery, the Director of NIH shall expand and intensify
research on pre-term labor and delivery.
‘‘(c) POST-PARTUM HEALTH CONDITIONS.—The Di-
rector of NIH shall expand and enhance research con-
cerning the post-partum health conditions and illness that
affect women.