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 demonstrating the safety and effectiveness of a drug if such 

approach satisfies the requirements of the applicable 

statutes and regulations. 

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 ‘‘Alternatives to Ani5 mals for Regulatory Fairness Act of 2020’’ or the ‘‘AARF 

6 Act of 2020’’. 


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•HR 8736 IH

1 SEC. 2. FINDINGS. 

2 The Congress finds that— 

3 (1) the Food and Drug Administration (in this 

4 section referred to as the ‘‘FDA’’) often requires 

5 pharmaceutical companies to conduct or commission 

6 testing on dogs and other animals to assess the safe7 ty or effectiveness of new drugs, even though such 

8 testing is inefficient, expensive, and ineffective; 

9 (2) the National Institutes of Health states, 

10 ‘‘Approximately 30 percent of promising medications 

11 have failed in human clinical trials because they are 

12 found to be toxic despite promising preclinical stud13 ies in animal models. About 60 percent of candidate 

14 drugs fail due to lack of efficacy’’; 

15 (3) current FDA nonbinding pharmaceutical 

16 testing guidelines support the use of alternatives to 

17 animal testing to improve the effectiveness and effi18 ciency of drug development; 

19 (4) current FDA drug testing guidance for the 

20 pharmaceutical industry states, ‘‘consideration 

21 should be given to use of new in vitro alternative 

22 methods for safety evaluation’’; 

23 (5) the FDA’s drug testing guidance for indus24 try additionally states, ‘‘alternative approaches . . . 

25 can also be used . . . . The use of any of these apVerDate Sep 11 2014 04:24 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8736.IH H8736

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•HR 8736 IH

1 proaches can reduce overall animal use in drug de2 velopment’’; 

3 (6) the FDA writes that alternatives to animal 

4 testing, ‘‘may help bring FDA-regulated products to 

5 market faster, with improved efficacy, or prevent 

6 products with increased toxicological risk from 

7 reaching the market. Also critical is the potential for 

8 these advances to replace, reduce, and/or refine ani9 mal testing’’; 

10 (7) pharmaceutical companies are reducing ani11 mal testing by investing in the development and use 

12 of alternative methods, which studies show are often 

13 more effective and efficient than traditional animal 

14 use; 

15 (8) the FDA states, ‘‘FDA encourages sponsors 

16 to consult with us if they wish to use a non-animal 

17 testing method they believe is suitable, adequate, 

18 validated, and feasible’’; and 

19 (9) in some cases, drug manufacturers and 

20 sponsors have not been allowed by the FDA to use 

21 alternatives to animal testing to fulfill regulatory re22 quirements, despite the FDA’s support for this tech23 nology in its industry guidance document. 


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•HR 8736 IH

1 SEC. 3. ALTERNATIVES TO ANIMAL TESTS. 

2 Section 505 of the Federal Food, Drug and Cosmetic 

3 Act (21 U.S.C. 355) is amended by adding at the end the 

4 following new subsection: 

5 ‘‘(z) ALTERNATIVES TO ANIMAL TESTS.—The Sec6 retary shall allow the sponsor of a drug to use a non-ani7 mal test as an alternative to an animal test for purposes 

8 of demonstrating the safety and effectiveness of a drug 

9 under this section if such approach satisfies the require10 ments of the applicable statutes and regulations.’’. 

Æ 


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