107th Congress

SAFE MOTHERHOOD ACT FOR RESEARCH AND TREATMENT (SMART MOM ACT)
S. 2328/H.R. 4602

Background

According to statistics released by the National Center for Health Statistics in May 2001, 3,193 pregnancy-related deaths occurred from 1991 through 1997. In 1998, the rate of maternal deaths was 7.1 per 100,000 live births. (See Healthy People 2010, objective 16-4.) Hispanic, Asian/Pacific Islander, and American Indian/Alaska Native women suffer a significantly higher risk of pregnancy-related mortality than non-Hispanic white women, while African-American women continue to have the highest risk of all these racial and ethnic groups. One of the goals of Healthy People 2010 is to reduce significantly both maternal mortality associated with pregnancy and maternal illness and complications due to pregnancy. In 1998, there were 31.2 maternal complications for every 100 deliveries. (See Health People 2010, objective 16.5.) Such complications included miscarriage, ectopic pregnancy, excessive vomiting, diabetes, hemmorhage, infection, preeclampsia, preterm labor, and the need for a caesarian delivery.

To address these issues, Senator Tom Harkin (D-IA) and several cosponsors, including Senators Edward M. Kennedy (D-MA), Barbara Mikulski (D-MD), and Christopher Dodd (D-CT), introduced S. 2328, the Safe Motherhood Act for Research and Treatment, known as the SMART Mom Act. The companion bill, H.R. 4602, was introduced by Representative John D. Dingell (D-MI). The bill was introduced in an effort to raise the understanding and treatment of complications that women suffer during pregnancy, and to ensure that women receive the information and services they need to have safe healthy pregnancies. In Senator Harkin's press release accompanying introduction of the bill, he stated, "the legislation calls for making research of pregnancy-and providing women reliable pregnancy information-a priority for the Federal Government's efforts to address women's health." He also stated, "experts agree that the rate of death and complications could be decreased by half with improved research and treatment." Senator Mikulski stated in her own press release that "the United States ranks below 29 other countries in pregnancy-related deaths, including Cyprus, Singapore, and Malta. We have not had a decline in U.S. maternal death rate in the last 20 years." In general, the bill is intended to 1) increase research efforts relating to pregnancy, 2) ensure that women understand the effect that medication and medical devices have on pregnant women, and 3) provide one-stop shopping for comprehensive pregnancy-related information via a new Government Web site, www.pregnancy.gov.

Provisions of the Legislation/Impact on NIH

The bill contains the following key provisions of interest to the National Institutes of Health (NIH):

• The bill would require the creation of an Interagency Coordinating Committee on Safe Motherhood (Coordinating Committee), which would include the Director of NIH and representatives from other U.S. Department of Health and Human Services (DHHS) agencies. The Coordinating Committee would also include the Secretary of Labor; representatives of other Federal Government agencies that serve women; representatives of women's health care advocacy and grassroots organizations; health care providers, including providers of specialty care; and researchers to be appointed by the DHHS Office of Women's Health.
• The bill would require the Coordinating Committee to develop a coordinated Federal research plan for safe motherhood. The Coordinating Committee would be required to consult with the Directors of NIH, the Centers for Disease Control and Prevention, and the Director of the Agency for Healthcare Research and Quality to determine key indicators of maternal health and sources of data to be included in a biannual report to Congress entitled "American's Mothers: Key Indicators of Well Being."
• The bill would require the Coordinating Committee to develop a national public education and health promotion campaign, including the maintenance of an Internet site, www.pregnancy.gov.
• The bill would require the Director of NIH to enhance and expand research into the leading causes of pregnancy-related death and complications of pregnancy, including research on preterm labor, postpartum health conditions, and health disparities.
• The bill would require the Director of NIH to expand research concerning the impact of chronic conditions, physical impairments, and mental health problems on the health of women during their pregnancy. In carrying out this section, the bill would require the Director of the National Institute of Child Health and Human Development to collaborate with other NIH Institutes and Offices.
• The bill would codify the existing Maternal Fetal Medicine Units Network.
• The bill would require NIH to expand the longitudinal children's health study required under Section 1004 of the Children's Health Act (42 U.S.C. 285g note) to include a research study of mothers to determine the effects of pregnancy on women's health.
• The bill would require the Director of NIH, in consultation with the Food and Drug Administration (FDA) and experts in maternal and fetal health, to identify marketed drugs and biological products that were not approved or licensed based on studies in pregnant women. The Director of NIH would be responsible (as resources allow) for conducting or supporting studies in order to establish appropriate dosing for women who are pregnant or lactating, and to investigate the marketed drugs and biological products' safe use for pregnant women and fetuses through the use of pregnancy registries and pharmacoepidemiological databases.
• The bill would require the Director of NIH, in consultation with FDA, to identify materials used in devices which come in contact with the body and for which there is insufficient information to assess their safety for persons and fetuses. The Director of NIH would be responsible (as resources allow) for funding such studies.

Status and Outlook

S. 2328 was introduced by Senator Harkin on April 25, 2002, and referred to the Senate Committee on Health, Education, Labor and Pensions (HELP). The companion bill, H.R. 4602, was introduced by Representative Dingell on April 25, and referred to the House Committee on Energy and Commerce. Although S. 2328 was scheduled for markup in the Senate HELP Committee several times, the bill has still not been considered by that Committee. H.R. 4602 has not received any action in the House. It is possible that S. 2328 will be combined with other pending women's health bills and will be considered by the Senate HELP Committee in September. For information on other women's health bills, see the article entitled "Women's Health."