FDA Modernization Act of 2021

Bill: 117-s-2952
Sponsor: full_name: Sen. Paul, Rand [R-KY]
Introduced: 2021-10-07
Policy area: Health
Latest action: action_date: 2021-10-07
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2021-10-07
action_desc: Introduced in Senate
text: <p><strong>FDA Modernization Act of 2021</strong></p> <p>This bill allows an applicant for market approval for a new drug to use methods other than animal testing to establish the drug's safety and effectiveness. Under this bill, these alternative methods may include cell-based assays, organ chips and microphysiological systems, computer modeling, and other human biology-based test methods.</p>

tv_txt: II 117th CONGRESS 1st Session S. 2952 IN THE SENATE OF THE UNITED STATES October 7, 2021 Mr. Paul (for himself, Mr. Booker , Mr. Braun , Mr. Kennedy , and Mr. Luján ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 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. New approach methodologies 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 preclinical tests (including tests on animals) and inserting nonclinical tests ; and (B) in paragraph (2)(B), by striking animal 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 conducted in vitro, in silico, in chemico, or in vivo that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include the following: (1) Cell-based assays. (2) Organ chips and microphysiological systems. (3) Computer models. (4) Other non-animal or human biology-based test methods. (5) Animal tests. .