I 
116TH CONGRESS 
2D SESSION 
H. R. 8736 
To amend the Federal Food, Drug, and Cosmetic Act to allow the sponsor 
of a drug to use a non-animal test as an alternative to an animal 
test for purposes of demonstrating the safety and effectiveness of a 
drug if such approach satisfies the requirements of the applicable statutes 
and regulations. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 12, 2020 
Mr. BRENDAN F. BOYLE of Pennsylvania 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 
allow the sponsor of a drug to use a non-animal test 
as an alternative to an animal test for purposes of dem-
onstrating the safety and effectiveness of a drug if such 
approach satisfies the requirements of the applicable 
statutes and regulations. 
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 ‘‘Alternatives to Ani-
mals for Regulatory Fairness Act of 2020’’ or the ‘‘AARF 
Act of 2020’’. 
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SEC. 2. FINDINGS. 
The Congress finds that— 
(1) the Food and Drug Administration (in this 
section referred to as the ‘‘FDA’’) often requires 
pharmaceutical companies to conduct or commission 
testing on dogs and other animals to assess the safe-
ty or effectiveness of new drugs, even though such 
testing is inefficient, expensive, and ineffective; 
(2) the National Institutes of Health states, 
‘‘Approximately 30 percent of promising medications 
have failed in human clinical trials because they are 
found to be toxic despite promising preclinical stud-
ies in animal models. About 60 percent of candidate 
drugs fail due to lack of efficacy’’; 
(3) current FDA nonbinding pharmaceutical 
testing guidelines support the use of alternatives to 
animal testing to improve the effectiveness and effi-
ciency of drug development; 
(4) current FDA drug testing guidance for the 
pharmaceutical 
industry 
states, 
‘‘consideration 
should be given to use of new in vitro alternative 
methods for safety evaluation’’; 
(5) the FDA’s drug testing guidance for indus-
try additionally states, ‘‘alternative approaches . . . 
can also be used . . . . The use of any of these ap-
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proaches can reduce overall animal use in drug de-
velopment’’; 
(6) the FDA writes that alternatives to animal 
testing, ‘‘may help bring FDA-regulated products to 
market faster, with improved efficacy, or prevent 
products with increased toxicological risk from 
reaching the market. Also critical is the potential for 
these advances to replace, reduce, and/or refine ani-
mal testing’’; 
(7) pharmaceutical companies are reducing ani-
mal testing by investing in the development and use 
of alternative methods, which studies show are often 
more effective and efficient than traditional animal 
use; 
(8) the FDA states, ‘‘FDA encourages sponsors 
to consult with us if they wish to use a non-animal 
testing method they believe is suitable, adequate, 
validated, and feasible’’; and 
(9) in some cases, drug manufacturers and 
sponsors have not been allowed by the FDA to use 
alternatives to animal testing to fulfill regulatory re-
quirements, despite the FDA’s support for this tech-
nology in its industry guidance document. 
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SEC. 3. ALTERNATIVES TO ANIMAL TESTS. 
Section 505 of the Federal Food, Drug and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the 
following new subsection: 
‘‘(z) ALTERNATIVES TO ANIMAL TESTS.—The Sec-
retary shall allow the sponsor of a drug to use a non-ani-
mal test as an alternative to an animal test for purposes 
of demonstrating the safety and effectiveness of a drug 
under this section if such approach satisfies the require-
ments of the applicable statutes and regulations.’’. 
Æ 
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