I 

117TH CONGRESS 

1ST SESSION H. R. 1905 

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 

MARCH 16, 2021 

Mr. BRENDAN F. BOYLE of Pennsylvania (for himself, Ms. DEAN, Mr. 

FITZPATRICK, and Mr. HASTINGS) 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, 


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•HR 1905 IH

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Alternatives to Ani3 mals for Regulatory Fairness Act of 2021’’ or the ‘‘AARF 

4 Act of 2021’’. 

5 SEC. 2. FINDINGS. 

6 The Congress finds that— 

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

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

9 pharmaceutical companies to conduct or commission 

10 testing on dogs and other animals to assess the safe11 ty or effectiveness of new drugs, even though such 

12 testing is inefficient, expensive, and ineffective; 

13 (2) the National Institutes of Health states, 

14 ‘‘Approximately 30 percent of promising medications 

15 have failed in human clinical trials because they are 

16 found to be toxic despite promising preclinical stud17 ies in animal models. About 60 percent of candidate 

18 drugs fail due to lack of efficacy’’; 

19 (3) current FDA nonbinding pharmaceutical 

20 testing guidelines support the use of alternatives to 

21 animal testing to improve the effectiveness and effi22 ciency of drug development; 

23 (4) current FDA drug testing guidance for the 

24 pharmaceutical industry states, ‘‘consideration 

25 should be given to use of new in vitro alternative 

26 methods for safety evaluation’’; 


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•HR 1905 IH

1 (5) the FDA’s drug testing guidance for indus2 try additionally states, ‘‘alternative approaches . . . 

3 can also be used . . . . The use of any of these ap4 proaches can reduce overall animal use in drug de5 velopment’’; 

6 (6) the FDA writes that alternatives to animal 

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

8 market faster, with improved efficacy, or prevent 

9 products with increased toxicological risk from 

10 reaching the market. Also critical is the potential for 

11 these advances to replace, reduce, and/or refine ani12 mal testing’’; 

13 (7) pharmaceutical companies are reducing ani14 mal testing by investing in the development and use 

15 of alternative methods, which studies show are often 

16 more effective and efficient than traditional animal 

17 use; 

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

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

20 testing method they believe is suitable, adequate, 

21 validated, and feasible’’; and 

22 (9) in some cases, drug manufacturers and 

23 sponsors have not been allowed by the FDA to use 

24 alternatives to animal testing to fulfill regulatory reVerDate Sep 11 2014 21:14 May 11, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1905.IH H1905

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•HR 1905 IH

1 quirements, despite the FDA’s support for this tech2 nology in its industry guidance document. 

3 SEC. 3. ALTERNATIVES TO ANIMAL TESTS. 

4 Section 505 of the Federal Food, Drug and Cosmetic 

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

6 following new subsection: 

7 ‘‘(z) ALTERNATIVES TO ANIMAL TESTS.—The Sec8 retary shall allow the sponsor of a drug to use a non-ani9 mal test as an alternative to an animal test for purposes 

10 of demonstrating the safety and effectiveness of a drug 

11 under this section if such approach satisfies the require12 ments of the applicable statutes and regulations.’’. 

Æ 


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