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 prod-
ucts 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 Representa-
tives 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 2015’’. 
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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 re-
view 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 suffi-
cient 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 EF-
FECTIVE TREATMENT FOR MALES OR FE-
MALES. 
(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 BIOLOGI-
CAL 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, facili-
tate the development and expedite the review of such 
drug if the drug— 
‘‘(A) is intended— 
‘‘(i) to avoid serious adverse events; or 
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‘‘(ii) to treat a serious or life-threat-
ening 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 popu-
lation or the other sex; and 
‘‘(C) is supported by results of clinical 
trials that include and separately examine out-
comes for both men and women. 
‘‘(2) DESIGNATION.—At the request of the 
sponsor of an eligible product described in para-
graph (1), the Secretary shall designate the drug as 
an expedited product to provide safer or more effec-
tive treatment for males or females. 
‘‘(3) EARLY
AND
FREQUENT
COMMUNICA-
TION.—The Secretary shall, with respect to each ex-
pedited product designated under this subsection, 
provide early and frequent communication and re-
view of incomplete applications to the same extent 
and in the same manner as is provided under sub-
sections (b) and (d). 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed— 
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‘‘(A) to lessen or otherwise alter the stand-
ard of safety and effectiveness required for the 
approval or licensing of drugs or biological 
products under section 505 of this Act or sec-
tion 351 of the Public Health Service Act; or 
‘‘(B) to authorize application of the provi-
sions of subsection (c) (relating to the use of 
surrogate endpoints) to expedited products des-
ignated 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 des-
ignated 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 fol-
lows 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 amend-
ed— 
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(A) 
by 
redesignating 
subsections 
(b) 
through (g) as subsections (c) through (h), re-
spectively; and 
(B) by inserting after subsection (a) the 
following: 
‘‘(b) INCLUSION OF SEX DIFFERENCES IN BASIC RE-
SEARCH.— 
‘‘(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 DETERMINA-
TION; UPDATES.—The Director of NIH— 
‘‘(i) shall make the initial determina-
tions required by subparagraph (A) not 
later than one year after the date of enact-
ment of the Research for All Act of 2015; 
and 
‘‘(ii) may subsequently update or re-
vise such determinations as the Director 
determines appropriate. 
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‘‘(C) CONSULTATION.—In making the ini-
tial 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 Ani-
mal Welfare, and appropriate members of 
the scientific and academic communities; 
and 
‘‘(ii) may conduct outreach and edu-
cational 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 commu-
nities 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 Re-
search for All Act of 2015, in conducting or sup-
porting basic research in accordance with paragraph 
(1), the Director of NIH shall, subject to paragraph 
(3), ensure that— 
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