AARF Act of 2020

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Alternatives to Ani- 4 mals for Regulatory Fairness Act of 2020’’ or the ‘‘AARF 5 Act of 2020’’. 6 VerDate Sep 11 2014 04:24 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8736.IH H8736 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 8736 IH SEC. 2. FINDINGS. 1 The Congress finds that— 2 (1) the Food and Drug Administration (in this 3 section referred to as the ‘‘FDA’’) often requires 4 pharmaceutical companies to conduct or commission 5 testing on dogs and other animals to assess the safe- 6 ty or effectiveness of new drugs, even though such 7 testing is inefficient, expensive, and ineffective; 8 (2) the National Institutes of Health states, 9 ‘‘Approximately 30 percent of promising medications 10 have failed in human clinical trials because they are 11 found to be toxic despite promising preclinical stud- 12 ies in animal models. About 60 percent of candidate 13 drugs fail due to lack of efficacy’’; 14 (3) current FDA nonbinding pharmaceutical 15 testing guidelines support the use of alternatives to 16 animal testing to improve the effectiveness and effi- 17 ciency of drug development; 18 (4) current FDA drug testing guidance for the 19 pharmaceutical industry states, ‘‘consideration 20 should be given to use of new in vitro alternative 21 methods for safety evaluation’’; 22 (5) the FDA’s drug testing guidance for indus- 23 try additionally states, ‘‘alternative approaches . . . 24 can also be used . . . . The use of any of these ap- 25 VerDate Sep 11 2014 04:24 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8736.IH H8736 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 8736 IH proaches can reduce overall animal use in drug de- 1 velopment’’; 2 (6) the FDA writes that alternatives to animal 3 testing, ‘‘may help bring FDA-regulated products to 4 market faster, with improved efficacy, or prevent 5 products with increased toxicological risk from 6 reaching the market. Also critical is the potential for 7 these advances to replace, reduce, and/or refine ani- 8 mal testing’’; 9 (7) pharmaceutical companies are reducing ani- 10 mal testing by investing in the development and use 11 of alternative methods, which studies show are often 12 more effective and efficient than traditional animal 13 use; 14 (8) the FDA states, ‘‘FDA encourages sponsors 15 to consult with us if they wish to use a non-animal 16 testing method they believe is suitable, adequate, 17 validated, and feasible’’; and 18 (9) in some cases, drug manufacturers and 19 sponsors have not been allowed by the FDA to use 20 alternatives to animal testing to fulfill regulatory re- 21 quirements, despite the FDA’s support for this tech- 22 nology in its industry guidance document. 23 VerDate Sep 11 2014 04:24 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8736.IH H8736 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 8736 IH SEC. 3. ALTERNATIVES TO ANIMAL TESTS. 1 Section 505 of the Federal Food, Drug and Cosmetic 2 Act (21 U.S.C. 355) is amended by adding at the end the 3 following new subsection: 4 ‘‘(z) ALTERNATIVES TO ANIMAL TESTS.—The Sec- 5 retary shall allow the sponsor of a drug to use a non-ani- 6 mal test as an alternative to an animal test for purposes 7 of demonstrating the safety and effectiveness of a drug 8 under this section if such approach satisfies the require- 9 ments of the applicable statutes and regulations.’’. 10 Æ VerDate Sep 11 2014 04:24 Nov 24, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H8736.IH H8736 pbinns on DSKJLVW7X2PROD with BILLS