I 

114TH CONGRESS 

1ST SESSION H. R. 2101 

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 

APRIL 29, 2015 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Research for All Act 

5 of 2015’’. 


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1 SEC. 2. SUFFICIENCY OF DESIGN AND SIZE OF CLINICAL 

2 TRIALS DURING EXPEDITED REVIEW. 

3 The Secretary of Health and Human Services, acting 

4 through the Commissioner of Food and Drugs, shall re5 view and develop policies, as appropriate, to ensure that 

6 the design and size of clinical trials for products granted 

7 expedited approval pursuant to section 506 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 356) are suffi9 cient to determine the safety and effectiveness of such 

10 products for men and women using subgroup analysis. 

11 SEC. 3. EXPEDITED REVIEW OF DRUGS AND BIOLOGICAL 

12 PRODUCTS TO PROVIDE SAFER OR MORE EF13 FECTIVE TREATMENT FOR MALES OR FE14 MALES. 

15 (a) IN GENERAL.—Section 506 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 356) is amended by 

17 adding at the end the following: 

18 ‘‘(g) EXPEDITED REVIEW OF DRUGS AND BIOLOGI19 CAL PRODUCTS TO PROVIDE SAFER OR MORE EFFECTIVE

20 TREATMENT FOR MALES OR FEMALES.— 

21 ‘‘(1) ELIGIBLE PRODUCT.—The Secretary shall, 

22 at the request of the sponsor of a new drug, facili23 tate the development and expedite the review of such 

24 drug if the drug— 

25 ‘‘(A) is intended— 

26 ‘‘(i) to avoid serious adverse events; or 


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1 ‘‘(ii) to treat a serious or life-threat2 ening disease or condition; 

3 ‘‘(B) whether alone or in combination with 

4 one or more other drugs or biological products, 

5 is intended for safer or more effective treatment 

6 for men or women than a currently available 

7 product approved to treat the general popu8 lation or the other sex; and 

9 ‘‘(C) is supported by results of clinical 

10 trials that include and separately examine out11 comes for both men and women. 

12 ‘‘(2) DESIGNATION.—At the request of the 

13 sponsor of an eligible product described in para14 graph (1), the Secretary shall designate the drug as 

15 an expedited product to provide safer or more effec16 tive treatment for males or females. 

17 ‘‘(3) EARLY AND FREQUENT COMMUNICA18 TION.—The Secretary shall, with respect to each ex19 pedited product designated under this subsection, 

20 provide early and frequent communication and re21 view of incomplete applications to the same extent 

22 and in the same manner as is provided under sub23 sections (b) and (d). 

24 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

25 this subsection shall be construed— 


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1 ‘‘(A) to lessen or otherwise alter the stand2 ard of safety and effectiveness required for the 

3 approval or licensing of drugs or biological 

4 products under section 505 of this Act or sec5 tion 351 of the Public Health Service Act; or 

6 ‘‘(B) to authorize application of the provi7 sions of subsection (c) (relating to the use of 

8 surrogate endpoints) to expedited products des9 ignated under this subsection.’’. 

10 (b) TECHNICAL CORRECTIONS.—Subsection (f) of 

11 section 506 of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 356) (relating to awareness efforts), as des13 ignated by section 902(a) of Public Law 112–144, is 

14 amended— 

15 (1) in paragraph (1), by striking ‘‘and and’’ 

16 and inserting ‘‘and’’; and 

17 (2) by moving such subsection (f) so that it fol18 lows subsection (e) of such section 506. 

19 SEC. 4. RESEARCH ON SEX DIFFERENCES. 

20 (a) INCLUSION IN NIH RESEARCH.— 

21 (1) IN GENERAL.—Section 492B of the Public 

22 Health Service Act (42 U.S.C. 289a–2) is amend23 ed— 


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1 (A) by redesignating subsections (b) 

2 through (g) as subsections (c) through (h), re3 spectively; and 

4 (B) by inserting after subsection (a) the 

5 following: 

6 ‘‘(b) INCLUSION OF SEX DIFFERENCES IN BASIC RE7 SEARCH.— 

8 ‘‘(1) APPLICABILITY TO BASIC RESEARCH.— 

9 ‘‘(A) IN GENERAL.—The Director of NIH 

10 shall determine when it is appropriate for 

11 projects of basic research involving cells, tissues 

12 or animals to include both male and female 

13 cells, tissues, or animals. 

14 ‘‘(B) DEADLINE FOR INITIAL DETERMINA15 TION; UPDATES.—The Director of NIH— 

16 ‘‘(i) shall make the initial determina17 tions required by subparagraph (A) not 

18 later than one year after the date of enact19 ment of the Research for All Act of 2015; 

20 and 

21 ‘‘(ii) may subsequently update or re22 vise such determinations as the Director 

23 determines appropriate. 


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1 ‘‘(C) CONSULTATION.—In making the ini2 tial determinations required by subparagraph 

3 (A), the Director of NIH— 

4 ‘‘(i) shall consult with the Office of 

5 Research on Women’s Health, the Institute 

6 of Medicine, the Office of Laboratory Ani7 mal Welfare, and appropriate members of 

8 the scientific and academic communities; 

9 and 

10 ‘‘(ii) may conduct outreach and edu11 cational initiatives within the scientific and 

12 academic communities on the influence of 

13 sex as a variable in basic research in order 

14 to develop a consensus within such commu15 nities on when it is appropriate for projects 

16 of basic research involving cells, tissues or 

17 animals to include both male and female 

18 cells, tissues, or animals. 

19 ‘‘(2) INCLUSION.—Beginning on the date that 

20 is 1 year after the date of enactment of the Re21 search for All Act of 2015, in conducting or sup22 porting basic research in accordance with paragraph 

23 (1), the Director of NIH shall, subject to paragraph 

24 (3), ensure that— 


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1 ‘‘(A) in the case of research on cells or tis2 sues— 

3 ‘‘(i) cells or tissues, as applicable, are 

4 derived from both male and female orga5 nisms in each project of such research; and 

6 ‘‘(ii) the results are disaggregated ac7 cording to whether the cells or tissues are 

8 derived from male or female organisms; 

9 and 

10 ‘‘(B) in the case of animal research— 

11 ‘‘(i) both male and female animals are 

12 included as subjects in each project of such 

13 research; and 

14 ‘‘(ii) the results are disaggregated ac15 cording to whether the subjects are male 

16 or female. 

17 ‘‘(3) EXCEPTION.—Paragraph (2) shall not 

18 apply to a project of basic research if the Director 

19 of NIH determines that the inclusion of cells or tis20 sues derived from both male and female organisms, 

21 or the inclusion of both male and female animals as 

22 subjects, as applicable, is inappropriate in the case 

23 of such project.’’. 


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1 (2) DESIGN OF RESEARCH.—Subsection (d) of 

2 section 492B of the Public Health Service Act (42 

3 U.S.C. 289a–2), as redesignated, is amended— 

4 (A) by striking ‘‘(d)’’ and all that follows 

5 through ‘‘In the case’’ and inserting the fol6 lowing: 

7 ‘‘(d) DESIGN OF RESEARCH.— 

8 ‘‘(1) CLINICAL TRIALS.—In the case’’; and 

9 (B) by adding at the end the following: 

10 ‘‘(2) BASIC RESEARCH.—In the case of basic 

11 research in which cells or tissues derived from both 

12 male and female organisms will be included in ac13 cordance with subsection (b)(2)(A) or both male and 

14 female animals will be included as subjects in ac15 cordance with subsection (b)(2)(B), the Director of 

16 NIH shall ensure that sex differences are examined 

17 and analyzed, as appropriate.’’. 

18 (3) UPDATING GUIDELINES FOR CLINICAL AND

19 BASIC RESEARCH.—Section 492B(f)(1) of the Public 

20 Health Service Act (42 U.S.C. 289a–2), as redesig21 nated, is amended to read as follows: 

22 ‘‘(1) DATE CERTAIN; UPDATE.—The guidelines 

23 required in subsection (e) regarding the require24 ments of this section for clinical and basic research 

25 shall— 


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1 ‘‘(A) be updated and published in the Fed2 eral Register not later than 1 year after the 

3 date of enactment of the Research for All Act 

4 of 2015; 

5 ‘‘(B) reflect the growing understanding 

6 that sex differences matter; 

7 ‘‘(C) ensure better enforcement of the re8 quirements of this section by the personnel of 

9 the agencies of the National Institutes of 

10 Health responsible for reviewing grant pro11 posals; and 

12 ‘‘(D) include guidance on when research 

13 strongly supports or strongly negates the con14 clusion that there is a significant difference in 

15 how the variables being studied affect women or 

16 members of minority groups, as the case may 

17 be, relative to how such variables affect other 

18 subjects in the research.’’. 

19 (4) APPLICABILITY.—Section 492B(f)(2) of the 

20 Public Health Service Act (42 U.S.C. 289a–2), as 

21 redesignated, is amended by adding at the end the 

22 following: ‘‘For fiscal year 2017 and subsequent fis23 cal years, the Director of NIH may not approve any 

24 proposal of basic research to be conducted or sup25 ported by any agency of the National Institutes of 


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1 Health unless the proposal specifies the manner in 

2 which the research will comply with this section.’’. 

3 (5) CONFORMING CHANGES.—Section 492B of 

4 the Public Health Service Act (42 U.S.C. 289a–2) 

5 is amended— 

6 (A) in the heading of subsection (a), by 

7 striking ‘‘REQUIREMENT OF INCLUSION’’ and 

8 inserting ‘‘INCLUSION IN CLINICAL RE9 SEARCH’’; 

10 (B) in subsection (a)(1), by striking ‘‘sub11 section (b)’’ and inserting ‘‘subsection (c)’’; 

12 (C) in subsection (e)(1)(A), as redesig13 nated, by striking ‘‘subsection (b)’’ and insert14 ing ‘‘subsection (c)’’; 

15 (D) in subsection (e)(1)(B), as redesig16 nated, by striking ‘‘subsection (c)’’ and insert17 ing ‘‘subsection (d)’’; and 

18 (E) in subsection (e)(2), as redesignated, 

19 by striking ‘‘subsection (b)’’ and inserting ‘‘sub20 section (c)’’. 

21 (b) BIENNIAL REPORTS OF DIRECTOR OF NIH.— 

22 Subparagraph (C) of section 403(a)(4) of the Public 

23 Health Service Act (42 U.S.C. 283(a)(4)) is amended— 

24 (1) by redesignating clause (vi) as clause (vii); 

25 and 


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1 (2) by inserting after clause (v) the following: 

2 ‘‘(vi) Basic research, including a 

3 breakdown of the sex of organisms from 

4 which cells and tissues are derived, a 

5 breakdown of the sex of animal subjects, 

6 and such other information as may be nec7 essary to demonstrate compliance with sec8 tion 492B (regarding sex differences in 

9 basic research).’’. 

10 (c) SPECIAL CENTERS OF RESEARCH ON SEX DIF11 FERENCES.—Part H of title IV of the Public Health Serv12 ice Act is amended by inserting after section 492B of such 

13 Act (42 U.S.C. 289a–2) the following: 

14 ‘‘SEC. 492C. SPECIAL CENTERS OF RESEARCH ON SEX DIF15 FERENCES. 

16 ‘‘The Secretary may award grants or other support 

17 to entities for the continued operation and expansion of 

18 Special Centers of Research on Sex Differences.’’. 

19 (d) RULE OF CONSTRUCTION.—Nothing in this Act 

20 or the amendments made by this Act shall be construed 

21 to lessen any standard or requirement set forth in part 

22 1, 2, or 3 of subchapter A of chapter I of title 9, Code 

23 of Federal Regulations. 


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1 SEC. 5. GAO REPORTS. 

2 Not later than 1 year after the date of enactment 

3 of the Research for All Act of 2015, the Comptroller Gen4 eral of the United States shall— 

5 (1) submit to the Congress updated versions of 

6 the reports of the Government Accountability Office 

7 entitled ‘‘Women’s Health: NIH Has Increased Its 

8 Efforts To Include Women in Research’’ (published 

9 in May 2000; GAO/HEHS–00–96) and ‘‘Women’s 

10 Health: Women Sufficiently Represented in New 

11 Drug Testing, But FDA Oversight Needs Improve12 ment’’ (published in July 2001; GAO–01–754); and 

13 (2) in such updated reports— 

14 (A) examine the inclusion of women, fe15 male animals, and female-derived cells and tis16 sues in federally funded research over the past 

17 decade; 

18 (B) examine how Federal agencies report 

19 and analyze subgroup information and translate 

20 any differences to the medical community and 

21 patients; 

22 (C) determine whether the quality of care 

23 which women receive is being negatively im24 pacted by inclusion rates in basic and clinical 

25 research; and 


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1 (D) address current efforts within National 

2 Institutes of Health and other government 

3 agencies to encourage the sharing of research 

4 data on sex differences and evaluate mecha5 nisms to improve such sharing, including a pub6 licly accessible online system that will conform 

7 with policies protecting commercial, proprietary, 

8 or private information. 

Æ 


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