[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5219 Introduced in House (IH)]

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114th CONGRESS
  2d Session
                                H. R. 5219

To provide for the establishment of the Task Force on Research Specific 
 to Pregnant Women and Lactating Women, to require an annual report to 
    Congress on approved new drug applications with information on 
            pregnancy and lactation, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 12, 2016

Ms. Herrera Beutler (for herself and Ms. Castor of Florida) introduced 
 the following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
To provide for the establishment of the Task Force on Research Specific 
 to Pregnant Women and Lactating Women, to require an annual report to 
    Congress on approved new drug applications with information on 
            pregnancy and lactation, and for other purposes.

    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 Medications for Moms and Babies 
Act of 2016''.

SEC. 2. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN AND LACTATING 
              WOMEN.

    (a) Task Force.--
            (1) Establishment.--Not later than 90 days after the date 
        of enactment of this Act, the Secretary of Health and Human 
        Services (in this section referred to as the ``Secretary'') 
        shall establish a task force, in accordance with the Federal 
        Advisory Committee Act (5 U.S.C. App.), to be known as the Task 
        Force on Research Specific to Pregnant Women and Lactating 
        Women (in this section referred to as the ``Task Force'').
            (2) Duties.--The Task Force shall provide advice and 
        guidance to the Secretary regarding Federal activities related 
        to identifying and addressing gaps in knowledge and research 
        regarding safe and effective therapies for pregnant women and 
        lactating women, including the development of such therapies 
        and the collaboration on and coordination of such activities.
            (3) Membership.--
                    (A) Federal members.--The Federal members of the 
                Task Force shall be composed of the following members 
                (or their designees):
                            (i) The Director of the Centers for Disease 
                        Control and Prevention.
                            (ii) The Director of the National 
                        Institutes of Health, the Director of the 
                        Eunice Kennedy Shriver National Institute of 
                        Child Health and Human Development, and the 
                        directors of such other national research 
                        institutes as the Secretary determines 
                        appropriate.
                            (iii) The Commissioner of Food and Drugs.
                            (iv) The Director of the Office on Women's 
                        Health.
                            (v) The Director of the National Vaccine 
                        Program Office.
                            (vi) The head of any other research-related 
                        agency or department not described in clauses 
                        (i) through (v) that the Secretary determines 
                        appropriate, which may include the Department 
                        of Veterans Affairs and the Department of 
                        Defense.
                    (B) Non-federal members.--The non-Federal members 
                of the Task Force shall be composed of the following 
                members:
                            (i) Representatives from relevant medical 
                        societies with subject matter expertise on 
                        pregnant women, lactating women, or children.
                            (ii) Nonprofit organizations with expertise 
                        related to the health of women and children.
                            (iii) Relevant industry representatives.
                            (iv) Representatives of patient or consumer 
                        advocacy organizations.
                            (v) Other representatives, as appropriate.
                    (C) Limitations.--The non-Federal members described 
                in subparagraph (B) shall--
                            (i) compose not more than one-half, and not 
                        less than one-third, of the total membership of 
                        the Task Force; and
                            (ii) be appointed by the Secretary.
            (4) Termination.--
                    (A) In general.--Subject to subparagraph (B), the 
                Task Force shall terminate on the date that is 2 years 
                after the date on which the Task Force is established 
                under paragraph (1).
                    (B) Extension.--The Secretary may extend the 
                operation of the Task Force for one additional 2-year 
                period following the 2-year period described in 
                subparagraph (A), if the Secretary determines that the 
                extension is appropriate for carrying out the purpose 
                of this section.
            (5) Meetings.--The Task Force shall meet not less than 2 
        times each year and shall convene public meetings, as 
        appropriate, to fulfill its duties under paragraph (2).
            (6) Task force report to congress.--Not later than 18 
        months after the date on which the Task Force is established 
        under paragraph (1), and not later than 36 and 48 months after 
        such date if the Secretary extends the operation of the Task 
        Force pursuant to paragraph (4)(B), the Task Force shall 
        prepare and submit to the Secretary, the Committee on Health, 
        Education, Labor, and Pensions of the Senate, and the Committee 
        on Energy and Commerce of the House of Representatives a report 
        on gaps in knowledge and research regarding safe and effective 
        therapies for pregnant women and lactating women. Each such 
        report shall, at a minimum, include each of the following:
                    (A) A plan to identify and address gaps in 
                knowledge and research regarding safe and effective 
                therapies for pregnant women and lactating women, 
                including the development of such therapies.
                    (B) Ethical issues surrounding the inclusion of 
                pregnant women and lactating women in clinical 
                research.
                    (C) Effective communication strategies with health 
                care providers and the public on information relevant 
                to pregnant women and lactating women.
                    (D) Identification of Federal activities, 
                including--
                            (i) the state of research involving 
                        pregnant and lactating women;
                            (ii) recommendations for the coordination 
                        of, and collaboration on, research related to 
                        pregnant women and lactating women;
                            (iii) dissemination of research findings 
                        and information relevant to pregnant women and 
                        lactating women to providers and the public; 
                        and
                            (iv) existing Federal efforts and programs 
                        to improve the scientific understanding of the 
                        health impacts of therapies on pregnant women 
                        and lactating women and related birth and 
                        pediatric outcomes, including with respect to 
                        pharmacokinetics, pharmacodynamics, and 
                        toxicities.
                    (E) Recommendations to improve the development of 
                safe and effective therapies for pregnant women and 
                lactating women.
    (b) Confidentiality.--Nothing in this section authorizes the 
Secretary to disclose any information that is a trade secret, or other 
privileged or confidential information, described in section 552(b)(4) 
of title 5, United States Code, or section 1905 of title 18, United 
States Code.
    (c) Updating Protections for Pregnant Women and Lactating Women in 
Research.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, and not later than 3 and 4 years after 
        such date if the Secretary extends the operation of the Task 
        Force pursuant to subsection (a)(4)(B), the Secretary, taking 
        into consideration any recommendations of the Task Force 
        available at such time and in consultation with the heads of 
        relevant agencies of the Department of Health and Human 
        Services, shall, as appropriate, update regulations and 
        guidance, as applicable, regarding the inclusion of pregnant 
        women and lactating women in clinical research.
            (2) Criteria for excluding pregnant or lactating women.--In 
        updating any regulations or guidance described in paragraph 
        (1), the Secretary shall consider any appropriate criteria to 
        be used by institutional review boards and individuals 
        reviewing grant proposals for excluding from participating in 
        human subject research pregnant women or lactating women as a 
        study population requiring additional protections.

SEC. 3. ANNUAL REPORT FROM FDA ON APPROVED NEW DRUG APPLICATIONS WITH 
              INFORMATION ON PREGNANCY AND LACTATION.

    Not later than 1 year after the date of enactment of this Act, and 
not less than annually for the succeeding 9 years, the Commissioner of 
Food and Drugs shall submit to the appropriate committees of the 
Congress a report on--
            (1) the number of new drug applications and supplements to 
        such applications approved or licensed by the Food and Drug 
        Administration under section 505(c) of the Federal Food, Drug, 
        and Cosmetic Act or section 351(a) of the Public Health 
        Services Act (42 U.S.C. 262(a)) based on research that included 
        pregnant women or lactating women in trials;
            (2) the number of new drug applications and supplements to 
        such applications so approved or licensed that included data on 
        the excretion of the drug in breast milk;
            (3) the number of new drug applications and supplements to 
        such applications so approved or licensed with required 
        postmarket studies in pregnant or breastfeeding women; and
            (4) the number of drugs with respect to which a labeling 
        change is made to include new information regarding use in 
        pregnant or breastfeeding women.
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