FDA Modernization Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 2565 To amend the Federal Food, Drug, and Cosmetic Act to allow manufacturers and sponsors of a drug to use alternative testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes. IN THE HOUSE OF REPRESENTATIVES APRIL 15, 2021 Mr. BUCHANAN (for himself, Mrs. LURIA, Ms. MACE, Ms. SHERRILL, and 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 manufacturers and sponsors of a drug to use alter- native testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes. 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 ‘‘FDA Modernization 4 Act of 2021’’. 5 VerDate Sep 11 2014 21:58 May 28, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2565.IH H2565 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 2565 IH SEC. 2. ANIMAL TESTING ALTERNATIVES. 1 Section 505 of the Federal Food, Drug, and Cosmetic 2 Act (21 U.S.C. 355) is amended— 3 (1) in subsection (b)(5)(B)(i)(II), by striking 4 ‘‘animal’’ and inserting ‘‘nonclinical tests or stud- 5 ies’’; 6 (2) in subsection (i)— 7 (A) in paragraph (1)(A), by striking ‘‘(in- 8 cluding tests on animals)’’; and 9 (B) in paragraph (2)(B), by striking ‘‘ani- 10 mal or human studies’’ and inserting ‘‘nonclin- 11 ical tests or studies’’; and 12 (3) after subsection (y), by inserting the fol- 13 lowing: 14 ‘‘(z) NONCLINICAL TEST OR STUDY DEFINED.—For 15 purposes of this section, the term ‘nonclinical test or 16 study’ means a test or study that is most likely to predict 17 human response based on scientific evidence and occurs 18 before or during the clinical trial phase of the investigation 19 of the safety and effectiveness of a drug. Such test or 20 study may include the following: 21 ‘‘(1) Cell-based assays. 22 ‘‘(2) Organ chips and microphysiological sys- 23 tems. 24 ‘‘(3) Sophisticated computer modeling. 25 ‘‘(4) Other human biology-based test methods. 26 VerDate Sep 11 2014 21:58 May 28, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2565.IH H2565 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 2565 IH ‘‘(5) Animal tests.’’. 1 Æ VerDate Sep 11 2014 21:58 May 28, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H2565.IH H2565 pbinns on DSKJLVW7X2PROD with BILLS