Research for All Act of 2014 - Directs the Food and Drug Administration (FDA) to review and develop policies to ensure that the design and size of clinical trials for products granted expedited approval to treat a serious or life-threatening disease or condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis.
Amends the Federal Food, Drug, and Cosmetic Act to require FDA, at the request of the sponsor of a new drug, to facilitate the development and expedite its review if the drug is:
Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to determine when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals. Requires, in such cases, disaggregation of results according to sex. Provides guidelines for ensuring that sex differences are examined and analyzed.
Authorizes the Secretary of Health and Human Services (HHS) to support the continued operation and expansion of Special Centers of Research on Sex Differences.
Requires the Comptroller General (GAO) to provide to Congress updated versions of the reports entitled “Women's Health: NIH Has Increased Its Efforts To Include Women in Research” and “Women's Health: Women Sufficiently Represented in New Drug Testing, But FDA Oversight Needs Improvement,” including in the reports examination of:
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4879 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 4879
To amend the Federal Food, Drug, and Cosmetic Act to provide for
expedited review of drugs and biological products to provide safer or
more effective treatment for males or females, to amend the Public
Health Service Act to enhance the consideration of sex differences in
basic and clinical research, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 17, 2014
Mr. Cooper (for himself and Mrs. Lummis) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for
expedited review of drugs and biological products to provide safer or
more effective treatment for males or females, to amend the Public
Health Service Act to enhance the consideration of sex differences in
basic and clinical research, 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 ``Research for All Act of 2014''.
SEC. 2. SUFFICIENCY OF DESIGN AND SIZE OF CLINICAL TRIALS DURING
EXPEDITED REVIEW.
The Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall review and develop policies, as
appropriate, to ensure that the design and size of clinical trials for
products granted expedited approval pursuant to section 506 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) are sufficient to
determine the safety and effectiveness of such products for men and
women using subgroup analysis.
SEC. 3. EXPEDITED REVIEW OF DRUGS AND BIOLOGICAL PRODUCTS TO PROVIDE
SAFER OR MORE EFFECTIVE TREATMENT FOR MALES OR FEMALES.
(a) In General.--Section 506 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356) is amended by adding at the end the
following:
``(g) Expedited Review of Drugs and Biological Products To Provide
Safer or More Effective Treatment for Males or Females.--
``(1) Eligible product.--The Secretary shall, at the
request of the sponsor of a new drug, facilitate the
development and expedite the review of such drug if the drug--
``(A) is intended--
``(i) to avoid serious adverse events; or
``(ii) to treat a serious or life-
threatening disease or condition;
``(B) whether alone or in combination with one or
more other drugs or biological products, is intended
for safer or more effective treatment for men or women
than a currently available product approved to treat
the general population or the other sex; and
``(C) is supported by results of clinical trials
that include and separately examine outcomes for both
men and women.
``(2) Designation.--At the request of the sponsor of an
eligible product described in paragraph (1), the Secretary
shall designate the drug as an expedited product to provide
safer or more effective treatment for males or females.
``(3) Early and frequent communication.--The Secretary
shall, with respect to each expedited product designated under
this subsection, provide early and frequent communication and
review of incomplete applications to the same extent and in the
same manner as is provided under subsections (b) and (d).
``(4) Rule of construction.--Nothing in this subsection
shall be construed--
``(A) to lessen or otherwise alter the standard of
safety and effectiveness required for the approval or
licensing of drugs or biological products under section
505 of this Act or section 351 of the Public Health
Service Act; or
``(B) to authorize application of the provisions of
subsection (c) (relating to the use of surrogate
endpoints) to expedited products designated under this
subsection.''.
(b) Technical Corrections.--Subsection (f) of section 506 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) (relating to
awareness efforts), as designated by section 902(a) of Public Law 112-
144, is amended--
(1) in paragraph (1), by striking ``and and'' and inserting
``and''; and
(2) by moving such subsection (f) so that it follows
subsection (e) of such section 506.
SEC. 4. RESEARCH ON SEX DIFFERENCES.
(a) Inclusion in NIH Research.--
(1) In general.--Section 492B of the Public Health Service
Act (42 U.S.C. 289a-2) is amended--
(A) by redesignating subsections (b) through (g) as
subsections (c) through (h), respectively; and
(B) by inserting after subsection (a) the
following:
``(b) Inclusion of Sex Differences in Basic Research.--
``(1) Applicability to basic research.--
``(A) In general.--The Director of NIH shall
determine when it is appropriate for projects of basic
research involving cells, tissues or animals to include
both male and female cells, tissues, or animals.
``(B) Deadline for initial determination;
updates.--The Director of NIH--
``(i) shall make the initial determinations
required by subparagraph (A) not later than one
year after the date of enactment of the
Research for All Act of 2014; and
``(ii) may subsequently update or revise
such determinations as the Director determines
appropriate.
``(C) Consultation.--In making the initial
determinations required by subparagraph (A), the
Director of NIH--
``(i) shall consult with the Office of
Research on Women's Health, the Institute of
Medicine, the Office of Laboratory Animal
Welfare, and appropriate members of the
scientific and academic communities; and
``(ii) may conduct outreach and educational
initiatives within the scientific and academic
communities on the influence of sex as a
variable in basic research in order to develop
a consensus within such communities on when it
is appropriate for projects of basic research
involving cells, tissues or animals to include
both male and female cells, tissues, or
animals.
``(2) Inclusion.--Beginning on the date that is 1 year
after the date of enactment of the Research for All Act of
2014, in conducting or supporting basic research in accordance
with paragraph (1), the Director of NIH shall, subject to
paragraph (3), ensure that--
``(A) in the case of research on cells or tissues--
``(i) cells or tissues, as applicable, are
derived from both male and female organisms in
each project of such research; and
``(ii) the results are disaggregated
according to whether the cells or tissues are
derived from male or female organisms; and
``(B) in the case of animal research--
``(i) both male and female animals are
included as subjects in each project of such
research; and
``(ii) the results are disaggregated
according to whether the subjects are male or
female.
``(3) Exception.--Paragraph (2) shall not apply to a
project of basic research if the Director of NIH determines
that the inclusion of cells or tissues derived from both male
and female organisms, or the inclusion of both male and female
animals as subjects, as applicable, is inappropriate in the
case of such project.''.
(2) Design of research.--Subsection (d) of section 492B of
the Public Health Service Act (42 U.S.C. 289a-2), as
redesignated, is amended--
(A) by striking ``(d)'' and all that follows
through ``In the case'' and inserting the following:
``(d) Design of Research.--
``(1) Clinical trials.--In the case''; and
(B) by adding at the end the following:
``(2) Basic research.--In the case of basic research in
which cells or tissues derived from both male and female
organisms will be included in accordance with subsection
(b)(2)(A) or both male and female animals will be included as
subjects in accordance with subsection (b)(2)(B), the Director
of NIH shall ensure that sex differences are examined and
analyzed, as appropriate.''.
(3) Updating guidelines for clinical and basic research.--
Section 492B(f)(1) of the Public Health Service Act (42 U.S.C.
289a-2), as redesignated, is amended to read as follows:
``(1) Date certain; update.--The guidelines required in
subsection (e) regarding the requirements of this section for
clinical and basic research shall--
``(A) be updated and published in the Federal
Register not later than 1 year after the date of
enactment of the Research for All Act of 2014;
``(B) reflect the growing understanding that sex
differences matter;
``(C) ensure better enforcement of the requirements
of this section by the personnel of the agencies of the
National Institutes of Health responsible for reviewing
grant proposals; and
``(D) include guidance on when research strongly
supports or strongly negates the conclusion that there
is a significant difference in how the variables being
studied affect women or members of minority groups, as
the case may be, relative to how such variables affect
other subjects in the research.''.
(4) Applicability.--Section 492B(f)(2) of the Public Health
Service Act (42 U.S.C. 289a-2), as redesignated, is amended by
adding at the end the following: ``For fiscal year 2016 and
subsequent fiscal years, the Director of NIH may not approve
any proposal of basic research to be conducted or supported by
any agency of the National Institutes of Health unless the
proposal specifies the manner in which the research will comply
with this section.''.
(5) Conforming changes.--Section 492B of the Public Health
Service Act (42 U.S.C. 289a-2) is amended--
(A) in the heading of subsection (a), by striking
``Requirement of Inclusion'' and inserting ``Inclusion
in Clinical Research'';
(B) in subsection (a)(1), by striking ``subsection
(b)'' and inserting ``subsection (c)'';
(C) in subsection (e)(1)(A), as redesignated, by
striking ``subsection (b)'' and inserting ``subsection
(c)'';
(D) in subsection (e)(1)(B), as redesignated, by
striking ``subsection (c)'' and inserting ``subsection
(d)''; and
(E) in subsection (e)(2), as redesignated, by
striking ``subsection (b)'' and inserting ``subsection
(c)''.
(b) Biennial Reports of Director of NIH.--Subparagraph (C) of
section 403(a)(4) of the Public Health Service Act (42 U.S.C.
283(a)(4)) is amended--
(1) by redesignating clause (vi) as clause (vii); and
(2) by inserting after clause (v) the following:
``(vi) Basic research, including a
breakdown of the sex of organisms from which
cells and tissues are derived, a breakdown of
the sex of animal subjects, and such other
information as may be necessary to demonstrate
compliance with section 492B (regarding sex
differences in basic research).''.
(c) Special Centers of Research on Sex Differences.--Part H of
title IV of the Public Health Service Act is amended by inserting after
section 492B of such Act (42 U.S.C. 289a-2) the following:
``SEC. 492C. SPECIAL CENTERS OF RESEARCH ON SEX DIFFERENCES.
``The Secretary may award grants or other support to entities for
the continued operation and expansion of Special Centers of Research on
Sex Differences.''.
(d) Rule of Construction.--Nothing in this Act or the amendments
made by this Act shall be construed to lessen any standard or
requirement set forth in part 1, 2, or 3 of subchapter A of chapter I
of title 9, Code of Federal Regulations.
SEC. 5. GAO REPORTS.
Not later than 1 year after the date of enactment of the Research
for All Act of 2014, the Comptroller General of the United States
shall--
(1) submit to the Congress updated versions of the reports
of the Government Accountability Office entitled ``Women's
Health: NIH Has Increased Its Efforts To Include Women in
Research'' (published in May 2000; GAO/HEHS-00-96) and
``Women's Health: Women Sufficiently Represented in New Drug
Testing, But FDA Oversight Needs Improvement'' (published in
July 2001; GAO-01-754); and
(2) in such updated reports--
(A) examine the inclusion of women, female animals,
and female-derived cells and tissues in federally
funded research over the past decade;
(B) examine how Federal agencies report and analyze
subgroup information and translate any differences to
the medical community and patients;
(C) determine whether the quality of care which
women receive is being negatively impacted by inclusion
rates in basic and clinical research; and
(D) address current efforts within National
Institutes of Health and other government agencies to
encourage the sharing of research data on sex
differences and evaluate mechanisms to improve such
sharing, including a publicly accessible online system
that will conform with policies protecting commercial,
proprietary, or private information.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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