[Congressional Record Volume 148, Number 48 (Thursday, April 25, 2002)]
[Senate]
[Pages S3440-S3441]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HARKIN (for himself, Mr. Kennedy, Ms. Mikulski, and Mr. 
        Dodd):
  S. 2328. 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 
expand public health prevention, education and outreach, and to develop 
improved and more accurate data collection, related to maternal 
morbidity and mortality; to the Committee on Health, Education, Labor, 
and Pensions.
 Mr. HARKIN. Mr. President, over the last decade there has been 
a significant recognition of the importance and increase in funding of 
women's health research, including the establishment of Offices of 
Women's Health throughout various government agencies. Women's health 
issues and women, as participants, are now routinely included in 
research studies.
  Despite this progress, many gaps still exist. In particular, there is 
a troubling lack of research on pregnancy-related health issues. Too 
often we take pregnancy for granted; we do not view pregnancy as a 
woman's health issue with short and long term health consequences.
  Safe motherhood is a woman's ability to have a safe and healthy 
pregnancy and delivery. Of the 4 million women who give birth in the 
U.S. each year, over one-third--or one out of every 3--have a 
pregnancy-related complication before, during, or after delivery. These 
complications may cause long-term health problems or even death. 
Unfortunately, the causes and treatments of pregnancy-related 
complications are largely unknown and understudied.
  If fact, the United States ranks only 20th in maternal mortality 
rates out of 49 developed countries--that is barely better than the 
50th percentile, behind Cyprus, Singapore and Malta. Every day, two to 
there women die from pregnancy related complications. And despite the 
fact that maternal mortality was targeted in 1987 as part of Healthy 
People 2000, the maternal mortality rate in this country has not 
decreased in twenty years.
  The scariest part of this problem is we can't answer the most basic 
questions--what causes the complications, what can we do to prevent 
them, and how can we treat them?
  One example of this problem is preeclampsia, or high blood pressure. 
Yes, we know some indicators that place some women at greater risk than 
others for this complication. And yes, we know some steps that can be 
taken to reduce a women's risk. But we know shamefully little, with the 
exception of inducing labor, of how to really prevent or treat this 
problem. Yet 5 percent of all pregnancies are affected by this 
complication, which can cause blindness or even death and there has 
been a 40% increase in the incidence of preeclampsia over the last 10 
years.
  Likewise, we know almost nothing about which prescription drugs are 
safe for the fetus and effective for the mother. Most prescription 
drugs women take during pregnancy are necessary to maintain health. But 
only 1% of FDA approved drugs have been shown in controlled studies to 
show no risk to pregnant women and their babies. And 80% of FDA 
approved drugs lack adequate scientific evidence about use in 
pregnancy. That means that pregnant women are essentially forced

[[Page S3441]]

to take these medications with little or no knowledge about their 
impact on the fetus.
  Of course, we don't want pregnant women placed at risk by putting 
them in early stage clinical trials. But the fact is that pregnant 
women with chronic diseases, such as diabetes, asthma, or epilepsy, 
need to take medication to maintain their health and support the growth 
of the fetus. And even pregnant women who don't have chronic health 
conditions need across to safe and effective prescription drugs.
  And while people in Washington tend to throw around statistics to 
make a point, it is important to remember that behind each of these 
statistics is a real person and family. And yesterday, I had the 
opportunity to talk to a group of moms from my State of Iowa.
  Without exception, these moms talked about their frustration with a 
health care system that continues to fail to meet some of the most 
basic needs of pregnant women. They all rely on a group call Sidelines, 
that provides support and guidance to pregnant women on bed rest. While 
it is great that a group like Sidelines is there for our mom's, 
sisters, and daughters, it is shameful that there isn't more accurate 
and more widely available information to women and their providers.
  That is why earlier today, I, along with some of my colleagues, 
introduced the Safe Motherhood Act for Research and Treatment, or, 
SMART Mom Act. The SMART Mom Act will address these concerns by: 
Increasing research and data collection to learn how to prevent, treat, 
and cure pregnancy related complications; providing comprehensive 
information to pregnant women, practitioners, and the public; and, 
improving information about medication and medical device for pregnant 
women.
  Pregnancy is a natural and wonderful occurrence in a woman's life. 
The SMART Mom Act takes a critical step towards ensuring pregnancies 
and healthy outcomes for America's women.
                                 ______