[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.
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