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