[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2328 Introduced in Senate (IS)]







107th CONGRESS
  2d Session
                                S. 2328

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 SENATE OF THE UNITED STATES

                             April 25, 2002

   Mr. Harkin (for himself, Mr. Kennedy, Ms. Mikulski, and Mr. Dodd) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    Be it enacted by the Senate and House of Representatives 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 findings:
            (1) Pregnancy is a natural condition. Approximately 
        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 mortality 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-related 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 
        maternal deaths from 7.5 deaths per 100,000 to 3.3 per 100,000 
        for live births and no more than 5.0 maternal deaths per 
        100,000 births among African American women. Again in 2000, as 
        part of Healthy People 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 
        vomiting, diabetes, hemorrhage, infection, pre-eclampsia, 
        premature labor, and the need for a surgical (caesarean) 
        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, deliveries, and risk to their long-
        term health.
            (9) African American, Hispanic, and older women, have a 
        significantly increased risk of complications.
            (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 disability adjusted life years (DALYs) lost due to 
        each disease.
            (12) Most drugs women take during pregnancy are necessary 
        to maintain health. However, 80 percent of approved drugs lack 
        adequate scientific evidence 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 
        pregnancy and good health throughout the lives of American 
        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 dosing of drugs 
        and devices used to treat pregnant women with chronic 
conditions and women who become 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 mortality.

          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 `Interagency Coordinating Committee on Safe Motherhood' 
(referred 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 institutes, 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 institutes, centers and 
        offices as the Director determines 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 institutes, 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 Government agencies 
        that serve women; and
            ``(8) 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 Director of the Office.
    ``(c) Administrative Support.--The Secretary shall make available 
to the Coordinating Committee necessary and appropriate administrative 
support.
    ``(d) Duties.--
            ``(1) Evaluation.--The Coordinating Committee shall assess 
        health promotion campaigns that are administered by the Federal 
        Government (including smoking cessation programs, alcohol and 
        substance abuse treatment programs, and domestic violence 
        prevention programs), evaluate the effect that such campaigns 
        have on health during pregnancy if pregnancy was a focus, and 
        assess whether such programs may be adapted to emphasize the 
        importance of maternal health.
            ``(2) Federal research plan.--
                    ``(A) In general.--Not later than 18 months after 
                the date of enactment of this section, 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 depression, 
                        hemorrhage, and fever);
                            ``(v) recommendations for research on 
                        racial, ethnic, social, behavioral, and 
                        economic factors effecting pregnancy;
                            ``(vi) recommendations for research to 
                        improve outreach efforts, education programs, 
                        and prevention and health promotion strategies 
                        for pregnant women; and
                            ``(vii) a recommended plan and research 
                        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 submit to the Secretary and 
                the appropriate committees of Congress, a report 
                concerning the plan developed under this paragraph and 
                the results of the evaluation conducted under paragraph 
                (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 
                Agency 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 Coordinating Committee shall 
                prepare and submit to the appropriate committees of 
                Congress, a report, 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 Internet website 
                established under paragraph (4).
            ``(4) Safe motherhood campaign.--The Coordinating 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 Collection 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 collaboration with the Directors of other 
appropriate Institutes and Offices, to expand and intensify research 
activities with respect to conditions that lead to pregnancy-related 
illnesses, injury and death before, during, and after pregnancy and to 
expand research to improve understanding and treatment of pregnant 
women who have chronic disease, physical impairment, or mental health 
conditions.
    (b) Safe Motherhood as a Priority Area.--Subpart 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 motherhood across the National Institutes of 
Health, including the specific support and research awards allocated 
through the such Institutes.''.
    (c) Expanded Research Into Pregnancy.--Subpart 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 Pregnancy.--In order to 
improve the understanding of conditions and complications related to 
pregnancy, to lead to better treatments and care for women throughout 
their pregnancy, and to prevent pregnancy-related illnesses, injury 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 Delivery.--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 Director of NIH shall 
expand and enhance research concerning the post-partum health 
conditions and illness that affect women.
    ``(d) Reductions in Racial and Ethnic Disparities.--The Director of 
NIH shall provide for the conduct of research to investigate the 
mechanisms contributing to the disparities in maternal and perinatal 
outcomes of racial and ethnic populations and immigrant groups.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.
    (d) Improving the Understanding and Treatment of Chronic Conditions 
of Women During Pregnancy.--Part H of title IV of the Public Health 
Service Act (42 U.S.C. 289 et seq.) is amended by inserting after 
section 494A, the following:

``SEC. 494B. IMPROVING THE UNDERSTANDING AND TREATMENT OF CHRONIC 
              CONDITIONS OF WOMEN DURING PREGNANCY.

    ``(a) In General.--The Director of NIH shall expand research 
concerning the impact of chronic conditions, physical impairments, and 
mental health problems on the health of women during their pregnancy.
    ``(b) Collaboration.--In carrying out subsection (a), the Director 
of the Institute shall act in collaboration with the Directors of other 
appropriate Institutes and Offices of the National Institutes of 
Health.''.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.
    (e) Maternal Fetal Medicine Units Network.--Subpart 7 of part C of 
title IV of the Public Health Service Act (42 U.S.C. 285g et seq.), as 
amended by subsection (c), is further amended by adding at the end the 
following:

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

    ``(a) In General.--The Director of the Institute shall establish a 
Maternal Fetal Medicine Units Network. In carrying out this subsection, 
the Director may enter into agreements to utilize the existing Maternal 
Fetal Medicine Units Network.
    ``(b) Expansion of Network.--The Director of the Institute shall, 
through grants, contracts, or cooperative agreements, expand the 
Maternal Fetal Medicine Units Network established or utilized under 
subsection (a) to assist in the implementation of sections 452I and 
494B.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

SEC. 112. EXPAND AND INTENSIFY RESEARCH ACTIVITIES AT THE CENTERS FOR 
              DISEASE CONTROL AND PREVENTION.

    (a) Reduction in Poor Pregnancy Outcomes of Ethnic and Minority 
Women.--Section 317K of the Public Health Service Act (42 U.S.C. 247b-
12) is amended--
            (1) by redesignating subsection (d) as subsection (f); and
            (2) by inserting after subsection (c), the following:
    ``(d) Reduction in Poor Pregnancy Outcomes of Ethnic and Minority 
Women.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall award grants to States to support community-based 
        demonstration projects in disease prevention and health 
        promotion to reduce disparities in pregnancy outcomes, with 
        particular emphasis on social, economic, and behavioral health 
        issues (including violence and obesity) affecting racial and 
        ethnic populations and immigrant groups. Where practicable, 
        such demonstration projects shall be based on relevant 
        scientific studies.
            ``(2) Technical assistance.--In carrying out paragraph (1), 
        the Secretary may provide technical assistance to States.''.
    (b) Prevention Research Centers.--Section 317K of the Public Health 
Service Act (42 U.S.C. 247b-12) is amended by inserting after 
subsection (d), as added by subsection (a) of this section, the 
following:
    ``(e) Prevention Research Centers.--The Director of the Centers for 
Disease Control and Prevention, acting through the National Center for 
Chronic Disease Prevention and Health Promotion, shall award grants to 
universities and other non-profit research institutions and centers to 
enable such entities to conduct research concerning improving maternal 
outcomes and eliminating racial disparities in maternal morbidity and 
mortality, with special emphasis provided to research concerning the 
role of stress, violence, discrimination, access, nutrition, obesity 
and literacy.''.

SEC. 113. IMPROVE QUALITY HEALTH CARE FOR PREGNANT WOMEN THROUGH AGENCY 
              FOR HEALTHCARE RESEARCH AND QUALITY.

    Section 913 of the Public Health Service Act (42 U.S.C. 299b-2) is 
amended by adding at the end the following:
    ``(c) Maternal Health Care.--
            ``(1) In general.--The Director shall provide for the 
        conduct of research concerning the quality of maternal health 
        care from a patient-centered perspective, including--
                    ``(A) the type of care that is available and 
                provided prior to, during, and after pregnancy;
                    ``(B) an examination of all types of care and 
                interventions, both medical and non-medical, as well as 
                barriers women face in gaining access to recommended 
                treatments; and
                    ``(C) recommendations for the minimum care needed 
                to be considered as having received quality care.
            ``(2) Report.--The results of the research conducted under 
        paragraph (1) shall be provided by the Director to Congress as 
        part of the annual report submitted under subsection (b)(2).''.

              Subtitle C--Data Collection and Surveillance

SEC. 121. EXPAND AND INTENSIFY DATA COLLECTION ACTIVITIES AT THE 
              CENTERS FOR DISEASE CONTROL AND PREVENTION.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317K the following:

``SEC. 317K-1. DATA COLLECTION REGARDING SAFE MOTHERHOOD.

    ``(a) Standard Definitions for Pregnancy-Related Mortality and 
Morbidity.--The Secretary, acting through the Director of the Centers 
for Disease Control and Prevention and in cooperation with State 
officials, professional medical experts, medical organizations, and 
health care advocacy groups, shall develop a standard definition of 
`maternal mortality' and `maternal morbidity'.
    ``(b) Grants for Surveillance of Pregnancy-Related Mortality and 
Morbidity Data.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall establish a program to award grants to States, counties, 
        and cities for the development of surveillance systems, that 
        use the standard definitions established under subsection (a), 
        to gather data on maternal mortality and maternal morbidity.
            ``(2) Eligibility.--To be eligible to receive a grant under 
        paragraph (1), a State, county, or city shall--
                    ``(A) prepare and submit to the Secretary an 
                application, at such time, in such manner, and 
                containing such information as the Secretary may 
                require;
                    ``(B) provide an assurance that the applicant will 
                work with the Centers for Disease Control and 
                Prevention to adopt standard procedures for the 
                identification, collection, and analysis of the data 
                that is to be collected under the grant; and
                    ``(C) provide an assurance that the applicant will 
                contribute $1 (in cash or in kind) to activities under 
                the grant for every $4 provided by the Federal 
                Government.
            ``(3) Technical assistance.--The Centers for Disease 
        Control and Prevention shall provide technical assistance to 
        grantees under this subsection.
            ``(4) Incorporation of data into report.--Where determined 
        appropriate by the Secretary, data collected by the 
        surveillance systems established under this subsection shall be 
        incorporated into the report submitted under section 
        399O(d)(3)(B).
    ``(c) Prevalence of Pre-Term Labor and Delivery.--The Secretary, 
acting through the Director of the Centers for Disease Control and 
Prevention, shall work with States and other entities to improve 
knowledge regarding the incidence and prevalence of symptoms and risk 
factors for pre-term births.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

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

    Section 1004 of the Children's Health Act of 2000 (42 U.S.C. 285g 
note) is amended--
            (1) by redesignating subsections (d) and (e) as subsections 
        (e) and (f), respectively; and
            (2) by inserting after subsection (c), the following:
    ``(d) Study on Effects of Pregnancy on Women.--As part of the study 
conducted under this section, the Director of the National Institute of 
Child Health and Human Development, in collaboration with the Director 
of the Centers for Disease Control and Prevention, the Commission on 
Food and Drugs, and other appropriate Federal officials, shall plan, 
develop, and implement a prospective cohort study of mothers to 
determine the effects of pregnancy on the health of women. Such study 
shall evaluate--
            ``(1) the effects of pregnancy on women's health;
            ``(2) the effects of both preexisting and chronic 
        conditions, physical impairments, and mental health problems 
        related to pregnancy;
            ``(3) the impact of stress and anxiety; and
            ``(4) environmental health factors that influence both the 
        mother's health and that of her child.''.

               Subtitle D--Public Education and Outreach

SEC. 131. PURPOSE.

    It is the purpose of this subtitle to address the need for 
providing women with accurate and up-to-date information through a 21st 
century public education and outreach Campaign for Safe Motherhood that 
shall raise the public awareness of the issues related to safe 
motherhood, including--
            (1) preventing pregnancy-related illnesses, injury, and 
        death; and
            (2) providing women and other interest parties with the 
        tools necessary to achieve safe and healthy pregnancies.

SEC. 132. SAFE MOTHERHOOD CAMPAIGN.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.), as amended by section 101, is further amended by adding 
at the end the following:

``SEC. 399P. SAFE MOTHERHOOD CAMPAIGN.

    ``(a) Establishment.--The Secretary, acting through the Director of 
the Office of Women's Health and the Interagency Coordinating Committee 
on Safe Motherhood (referred to in this section as the `Coordinating 
Committee') established under section 399O, shall develop and implement 
a national public education and health promotion campaign to be known 
as the Safe Motherhood Campaign (referred to in this section as the 
`Campaign').
    ``(b) Elements of Campaign.--The Campaign shall at a minimum 
include the following:
            ``(1) Website.--An Internet website to be established in 
        accordance with subsection (c).
            ``(2) Community partnerships.--The provision of support for 
        community-based programs to provide outreach, education, 
        information and health promotion services and information to 
        give women the tools they need to achieve a safe and healthy 
        pregnancy.
            ``(3) State and local partnerships.--The facilitation of 
        consultations with State and local public health officials to 
        gain access to the broadest number of women in an effort to 
        provide outreach and education assistance and information to 
        help women succeed in having a safe and healthy pregnancy.
            ``(4) Special populations.--The implementation of 
        procedures to ensure that activities under the Campaign are 
        accessible to low-literate, non-English speaking, and nonnative 
        immigrant communities where determined appropriate by the 
        Secretary.
    ``(c) Internet Website.--
            ``(1) Establishment.--The Secretary, acting through the 
        Office of Women's Health and the Coordinating Committee, shall 
        develop and maintain a single Internet website to provide 
        pregnant women, and research and health practitioners with the 
        most up-to-date and accurate information on pregnancy, in a 
        manner designed to carry out the purpose described in paragraph 
        (2).
            ``(2) Purpose.--It is the purpose of the website 
        established under paragraph (1) to consolidate information, 
        research, and data related to pregnancy (prenatal, intrapartum, 
        and postpartum) together in one place and to provide links for 
        women to other critical websites (Federal agencies, community 
        health programs, State and tribal health programs, and self-
        help professional and advocacy organizations).
            ``(3) Address.--The Secretary shall ensure that the uniform 
        resource locator for the website established under paragraph 
        (1) is www.pregnancy.gov. If such locator is not available, the 
        Secretary shall select another similar locator.
            ``(4) Contents.--The website established under paragraph 
        (1) shall, at a minimum, contain--
                    ``(A) educational materials for how to succeed in 
                having the safest pregnancy possible, including a 
                description of chronic conditions, pregnancy-related 
                illnesses, and other health problems that could pose 
                risks to the mother or fetus;
                    ``(B) information concerning the safety and risk of 
                prescription and over-the-counter medications and other 
                products that women might use during pregnancy;
                    ``(C) information concerning standards for clinical 
                care throughout pregnancy;
                    ``(D) information on trends in labor intervention, 
                such as induction, epidural, and caesarean sections, 
                and alternative approaches;
                    ``(E) information concerning the issue of domestic 
                violence during pregnancy, including how women can 
                obtain assistance;
                    ``(F) information concerning infertility and 
                maternal health; and
                    ``(G) information concerning pregnancy-related 
                workplace laws and policies, such as the Family and 
                Medical Leave Act of 1993.
            ``(5) Appropriate form of information.--The information 
        contained on the website established under paragraph (1) shall 
        be maintained in a culturally sensitive and appropriate form.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

                 TITLE II--PREGNANT AND LACTATING WOMEN

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

    (a) Amendment to Chapter V.--Chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the 
end the following:

``SEC. 564. SAFE DRUGS AND DEVICES FOR PREGNANT AND LACTATING WOMEN.

    ``(a) Improving the Quality of Information on Drugs and Biological 
Products for Women Who Are Pregnant or Lactating.--
            ``(1) Marketed drugs for which additional information is 
        needed.--
                    ``(A) Identifying drugs to be studied.--The 
                Secretary, acting through the Director of the National 
                Institutes of Health and in consultation with the 
                Commissioner of Food and Drugs and experts in maternal 
                and fetal health, shall--
                            ``(i) identify marketed drugs and 
                        biological products that were not approved or 
                        licensed based on studies in pregnant women for 
                        which studies are needed--
                                    ``(I) to establish appropriate 
                                dosing for women who are pregnant or 
                                lactating; and
                                    ``(II) to investigate the marketed 
                                drugs and biological products' safe use 
                                for pregnant women and fetuses through 
                                the use of pregnancy registries and 
                                pharmacoepidemiological databases; and
                            ``(ii) design protocols for the needed 
                        studies described in clause (i).
                    ``(B) Studying marketed drugs.--The Director of the 
                National Institutes of Health shall award grants, enter 
                into contracts, or use other appropriate mechanisms to 
                aid in promptly completing the studies designed under 
                subparagraph (A), as the National Institutes of 
                Health's resources allow.
            ``(2) Postmarketing studies.--As a condition of approval of 
        an application submitted under section 505(b)(1) or of a 
        biologics license application under section 351 of the Public 
        Health Service Act (42 U.S.C. 262), the Secretary may require 
        that the holder of the application conduct postmarketing 
        studies, to be completed and submitted to the Secretary by a 
        date specified by the Secretary, to--
                    ``(A) establish dosing recommendations for such 
                drug or biological product for women who are pregnant 
                or lactating; and
                    ``(B) investigate the safe use of such drug or 
                biological product for pregnant women and fetuses 
                through the use of pregnancy registries and 
                pharmacoepidemiological databases.
            ``(3) Pregnancy registries and pharmacoepidemiological 
        databases.--
                    ``(A) Registries.--The Secretary shall issue 
                guidances on the use and evaluation of data from 
                pregnancy registries, including data from centralized 
                registries for drugs and biological products.
                    ``(B) Databases.--
                            ``(i) Establishment.--The Secretary shall 
                        establish or award grants, enter into contracts 
                        and cooperative agreements, and use other 
                        appropriate mechanisms to provide for 
                        pharmacoepidemiological databases (including a 
                        teratogen surveillance system) to study safety 
                        issues related to drugs and biological 
                        products, including safety issues for pregnant 
                        women and fetuses.
                            ``(ii) Study and use of data.--The 
                        Secretary shall hold workshops and issue 
                        guidances on how to study and use the data from 
                        the pharmacoepidemiological databases 
                        established or provided for under clause (i).
            ``(4) Clarification regarding market exclusivity 
        interactions.--A clinical investigation involved in any study 
        conducted under this subsection shall not be considered to be a 
        new clinical investigation for purposes of clauses (iii) and 
        (iv) of section 505(j)(5(D).
    ``(b) Improving Communication of Information to Pregnant and 
Lactating Women and Their Health Care Providers Through Drug 
Labeling.--
            ``(1) Regulations.--
                    ``(A) Proposed regulation.--Not later than 6 months 
                after the date of enactment of this section, the 
                Secretary shall promulgate a proposed regulation 
                requiring enhanced communication of safety and dosage 
                information for women who are pregnant or lactating in 
                the labeling of drugs, including drugs licensed under 
                section 351 of the Public Health Service Act (42 U.S.C. 
                262).
                    ``(B) Final rule.--Not later than 2 years after the 
                date of enactment of this section, the Secretary shall 
                promulgate a final regulation requiring enhanced 
                communication of safety and dosage information for 
                women who are pregnant or lactating in the labeling of 
                drugs, including drugs licensed under section 351 of 
                the Public Health Service Act (42 U.S.C. 262).
            ``(2) Biennial review of certain drugs.--Not later than 32 
        months after the date of enactment of this section, and 
        biennially thereafter, each person who holds an approved 
        application for a drug under section 505(b) that was not 
        approved based on studies of pregnant women or who holds an 
        approved biologics license application for a drug under section 
        351 of the Public Health Service Act (42 U.S.C. 262) that was 
        not licensed based on studies of pregnant women, shall--
                    ``(A) review any newly available data or 
                information for such drug, including data or 
                information from the studies completed under subsection 
(a), to determine whether such data or information, and all other 
relevant data and information, warrants a labeling change for women who 
are pregnant or lactating; and
                    ``(B) submit to the Secretary--
                            ``(i) a supplement to the holders' new drug 
                        application or biologics license application 
                        that includes--
                                    ``(I) a summary of the data or 
                                information reviewed under subparagraph 
                                (A);
                                    ``(II) an analysis of why such data 
                                or information warrants a labeling 
                                change for women who are pregnant or 
                                lactating;
                                    ``(III) a proposal for the labeling 
                                change; and
                                    ``(IV) a certification that the 
                                review, summary, and analysis is 
                                complete and accurate; or
                            ``(ii) a letter that includes--
                                    ``(I) a summary of the data or 
                                information, if any, reviewed under 
                                subparagraph (A);
                                    ``(II) an analysis of why such data 
                                or information does not warrant a 
                                labeling change for women who are 
                                pregnant or lactating; and
                                    ``(III) a certification that the 
                                review, summary, and analysis is 
                                complete and accurate.
            ``(3) Biennial submissions.--In the regulations promulgated 
        under paragraph (1), the Secretary shall prescribe requirements 
        for--
                    ``(A) the summary of data or information reviewed 
                under paragraph (2)(A); and
                    ``(B) the analysis of why such data or information 
                does or does not warrant a labeling change required to 
                be submitted to the Secretary in a supplement or in a 
                letter under paragraph (2)(B).
            ``(4) Periodic review of drugs.--
                    ``(A) Priority.--Not later than 2 years after the 
                date of enactment of this section, the Secretary shall 
                prioritize marketed drugs that were not approved or 
                licensed based on studies in pregnant women, 
                considering--
                            ``(i) how widely such drugs are used by 
                        women who are pregnant or lactating;
                            ``(ii) whether new information available 
                        about such drugs may warrant a labeling change 
                        for such women; and
                            ``(iii) which of such drugs have labeling 
                        for such women that is most in need of 
                        revision.
                    ``(B) Regulations and orders.--
                            ``(i) Initial regulations and orders.--
                        Based on the prioritization of drugs under 
                        subparagraph (A), the Secretary shall, as 
                        resources allow--
                                    ``(I) promulgate regulations for 
                                such drugs that meet the conditions 
                                contained in any applicable monograph 
                                to revise safety and dosage information 
                                required in labeling for women who are 
                                pregnant or lactating; and
                                    ``(II) issue orders for other such 
                                drugs to require revised safety and 
                                dosage information required in labeling 
                                for women who are pregnant or 
                                lactating.
                            ``(ii) Subsequent regulations and orders.--
                        The Secretary shall periodically review new 
                        data or information as it becomes available on 
                        the drugs described in subparagraph (A), and 
                        shall promulgate regulations or issue orders, 
                        as appropriate, to revise safety and dosage 
                        information required in labeling for such drugs 
                        for women who are pregnant or lactating.
    ``(c) Improving Communication and Information About Fetal Risk From 
Devices.--
            ``(1) Research on materials used in devices.--
                    ``(A) Identifying materials to be studied.--The 
                Secretary, acting through the Director of the National 
                Institutes of Health and in consultation with the 
                Commissioner of Food and Drugs, shall--
                            ``(i) periodically review all available 
                        data and information about the safety for 
                        persons and fetuses of materials used in 
                        devices that may come into contact with, or be 
                        absorbed into, the body;
                            ``(ii) identify materials for which 
                        additional data or information is needed to 
                        assess the safety for persons and fetuses of 
                        such materials; and
                            ``(iii) design protocols for studies to 
                        collect data or information described in clause 
                        (ii).
                    ``(B) Studying device materials.--The Director of 
                the National Institutes of Health shall award grants, 
                enter into contracts, or use other appropriate 
                mechanisms to aid in promptly completing the studies 
                designed under subparagraph (A), as the National 
                Institutes of Health's resources allow.
                    ``(C) Safety studies.--The Secretary may require a 
                person that manufactures a device that bears or 
                contains a material for which the Secretary has 
                designed studies under subparagraph (A), to complete 
                and submit such studies to the Secretary, by a date 
                specified by the Secretary.
            ``(2) Review of device material and labeling.--Considering 
        all available data and information about the safety for persons 
        and fetuses of a material that may come into contact with, or 
        be absorbed into, the body when used in a device, including 
        data and information from studies conducted under paragraph 
        (1), the Secretary shall--
                    ``(A) require appropriate statements disclosing any 
                risks to persons or fetuses from the material in the 
                labeling of a device that bears or contains such 
                material; or
                    ``(B) if use of the material in a device presents 
                an unreasonable and substantial risk of illness or 
                injury to persons or fetuses, ban the use of such 
                material in such device.
    ``(d) Limitations on Injunctive Relief To Ensure Prompt Revision of 
Drug and Device Labeling.--In an action under section 302 with respect 
to a drug or a device deemed to be misbranded under section 502(k) or 
section 502(l), such misbranding shall not be the sole basis for any 
judicial order that requires a person to cease the manufacturing, 
distribution, or sale of such drug or device.
    ``(e) Outreach and Education.--The Secretary shall expand the 
Women's Health: Take Time to Care program or establish a new program 
that is directed at--
            ``(1) women who are pregnant or lactating to inform such 
        women about the safety issues involved in taking prescription 
        and over-the-counter drugs, and using medical devices, while 
        such women are pregnant or breast feeding; and
            ``(2) health care providers and the public to provide 
        information about the safety issues involved when women, who 
        are pregnant or breast feeding, take prescription and over-the-
        counter drugs or use medical devices.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, such sums as are necessary.''.
    (b) Amendment to Adulterated Drugs and Devices.--Section 501(g) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(g)) is amended 
by striking ``device'' and inserting ``device or it is a device that 
bears or contains a material whose use in such a device has been banned 
under section 564(c)(2)(B)''.
    (c) Amendment to Misbranded Drugs and Devices.--Section 502 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by 
inserting after subsection (j) the following:
    ``(k)(1) If it is a drug; and--
    ``(2)(A) a study required under section 564(a)(2) with respect to 
such drug is not completed and submitted to the Secretary by the date 
specified by the Secretary;
    ``(B) a supplement or letter required to be submitted to the 
Secretary under section 564(b)(2)(B) with respect to such drug is not 
submitted to the Secretary;
    ``(C) a supplement or letter required to be submitted to the 
Secretary under section 564(b)(2)(B) with respect to such drug does not 
include an adequate summary or analysis of relevant information or 
data; or
    ``(D) its labeling does not include safety or dosage information 
for pregnant or lactating women required by the Secretary by regulation 
or order under section 564(b)(4)(B).
    ``(l) If it is a device and its labeling does not include 
statements required by the Secretary under section 564(c)(2)(A).''.
    (d) Amendment to Civil Penalties.--Section 307(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 335b(a)) is amended--
            (1) in paragraph (6)(B), by striking ``or''; and
            (2) by inserting after paragraph (7) the following:
            ``(8) has failed to complete and submit to the Secretary, 
        by the date specified by the Secretary, a study required by the 
        Secretary under section 564(a)(2);
            ``(9) has failed to submit to the Secretary a supplement or 
        letter required to be submitted to the Secretary under section 
        564(b)(2)(B);
            ``(10) has failed to include an adequate summary or 
        analysis of relevant information or data in a supplement or 
        letter required to be submitted to the Secretary under section 
        564(b)(2)(B);
            ``(11) has distributed in interstate commerce a drug whose 
        labeling does not include safety or dosage information for 
        pregnant or lactating women required by the Secretary by 
        regulation or order under section 564(b)(4)(B);
            ``(12) has failed to complete and submit to the Secretary, 
        by the date specified by the Secretary, a study required under 
        section 564(c)(1)(C);
            ``(13) has distributed in interstate commerce a device 
        whose labeling does not include statements required by the 
        Secretary under section 564(c)(2)(A); or
            ``(14) has distributed in interstate commerce a device that 
        bears or contains a material whose use in such device has been 
        banned under section 564(c)(2)(B).''.
                                 <all>