H.R. 2565 — Introduced in House

I 117th CONGRESS 1st Session H. R. 2565 IN THE HOUSE OF REPRESENTATIVES April 15, 2021Mr. 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 alternative testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes. 1. Short title This Act may be cited as the FDA Modernization Act of 2021. 2. Animal testing alternatives Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended— (1) in subsection (b)(5)(B)(i)(II), by striking animal and inserting nonclinical tests or studies; (2) in subsection (i)— (A) in paragraph (1)(A), by striking (including tests on animals); and (B) in paragraph (2)(B), by striking animal or human studies and inserting nonclinical tests or studies; and (3) after subsection (y), by inserting the following: (z) Nonclinical test or study defined For purposes of this section, the term nonclinical test or study means a test or study that is most likely to predict human response based on scientific evidence and occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test or study may include the following: (1) Cell-based assays. (2) Organ chips and microphysiological systems. (3) Sophisticated computer modeling. (4) Other human biology-based test methods. (5) Animal tests. .