H. R. 2565
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
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.
This Act may be cited as the
FDA Modernization Act of 2021.
Animal testing alternatives
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
(including tests on animals); and
in paragraph (2)(B), by striking
animal or human studies 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 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:
Organ chips and microphysiological systems.
Sophisticated computer modeling.
Other human biology-based test methods.