S. 5002 — Considered and Passed (Senate)

II 117th CONGRESS 2d Session S. 5002 IN THE SENATE OF THE UNITED STATES September 29, 2022Mr. Paul (for himself, Mr. Booker, Mr. Braun, Mr. Crapo, Mr. Marshall, Ms. Collins, Mr. King, Mr. Padilla, Mr. Sanders, Mr. Tuberville, Mr. Luján, and Mr. Scott of Florida) introduced the following bill; which was read twice, considered, read the third time, and passed A BILL To allow for alternatives to animal testing for purposes of drug and biological product applications. 1. Short title This Act may be cited as the FDA Modernization Act 2.0. 2. Alternatives to animal testing (a) In general Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended— (1) in subsection (i)— (A) in paragraph (1)(A), by striking preclinical tests (including tests on animals) and inserting nonclinical tests; and (B) in paragraph (2)(B), by striking animal and inserting nonclinical tests; and (2) after subsection (y), by inserting the following: (z) Nonclinical test defined For purposes of this section, the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or bioprinted or computer models. . (b) Biosimilar biological product applications Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)(i)(I)) is amended to read as follows: (bb) an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and .