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.
Short title
This Act may be cited as the FDA Modernization Act of 2021
.
New approach methodologies
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—
in subsection (b)(5)(B)(i)(II), by striking animal
and inserting nonclinical tests or studies
;
in subsection (i)—
in paragraph (1)(A), by striking preclinical tests (including tests on animals)
and inserting nonclinical tests
; and
in paragraph (2)(B), by striking animal
and inserting nonclinical tests or studies
; and
after subsection (y), by inserting the following:
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:
Cell-based assays.
Organ chips and microphysiological systems.
Computer models.
Other non-animal or human biology-based test methods.
Animal tests.
.