AARF Act of 2021

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 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 VerDate Sep 11 2014 21:14 May 11, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1905.IH H1905 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 1905 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Alternatives to Ani- 2 mals for Regulatory Fairness Act of 2021’’ or the ‘‘AARF 3 Act of 2021’’. 4 SEC. 2. FINDINGS. 5 The Congress finds that— 6 (1) the Food and Drug Administration (in this 7 section referred to as the ‘‘FDA’’) often requires 8 pharmaceutical companies to conduct or commission 9 testing on dogs and other animals to assess the safe- 10 ty or effectiveness of new drugs, even though such 11 testing is inefficient, expensive, and ineffective; 12 (2) the National Institutes of Health states, 13 ‘‘Approximately 30 percent of promising medications 14 have failed in human clinical trials because they are 15 found to be toxic despite promising preclinical stud- 16 ies in animal models. About 60 percent of candidate 17 drugs fail due to lack of efficacy’’; 18 (3) current FDA nonbinding pharmaceutical 19 testing guidelines support the use of alternatives to 20 animal testing to improve the effectiveness and effi- 21 ciency of drug development; 22 (4) current FDA drug testing guidance for the 23 pharmaceutical industry states, ‘‘consideration 24 should be given to use of new in vitro alternative 25 methods for safety evaluation’’; 26 VerDate Sep 11 2014 21:14 May 11, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1905.IH H1905 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 1905 IH (5) the FDA’s drug testing guidance for indus- 1 try additionally states, ‘‘alternative approaches . . . 2 can also be used . . . . The use of any of these ap- 3 proaches can reduce overall animal use in drug de- 4 velopment’’; 5 (6) the FDA writes that alternatives to animal 6 testing, ‘‘may help bring FDA-regulated products to 7 market faster, with improved efficacy, or prevent 8 products with increased toxicological risk from 9 reaching the market. Also critical is the potential for 10 these advances to replace, reduce, and/or refine ani- 11 mal testing’’; 12 (7) pharmaceutical companies are reducing ani- 13 mal testing by investing in the development and use 14 of alternative methods, which studies show are often 15 more effective and efficient than traditional animal 16 use; 17 (8) the FDA states, ‘‘FDA encourages sponsors 18 to consult with us if they wish to use a non-animal 19 testing method they believe is suitable, adequate, 20 validated, and feasible’’; and 21 (9) in some cases, drug manufacturers and 22 sponsors have not been allowed by the FDA to use 23 alternatives to animal testing to fulfill regulatory re- 24 VerDate Sep 11 2014 21:14 May 11, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1905.IH H1905 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 1905 IH quirements, despite the FDA’s support for this tech- 1 nology in its industry guidance document. 2 SEC. 3. ALTERNATIVES TO ANIMAL TESTS. 3 Section 505 of the Federal Food, Drug and Cosmetic 4 Act (21 U.S.C. 355) is amended by adding at the end the 5 following new subsection: 6 ‘‘(z) ALTERNATIVES TO ANIMAL TESTS.—The Sec- 7 retary shall allow the sponsor of a drug to use a non-ani- 8 mal test as an alternative to an animal test for purposes 9 of demonstrating the safety and effectiveness of a drug 10 under this section if such approach satisfies the require- 11 ments of the applicable statutes and regulations.’’. 12 Æ VerDate Sep 11 2014 21:14 May 11, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H1905.IH H1905 pamtmann on DSKBC07HB2PROD with BILLS