FDA Modernization Act of 2021

Bill: 117-hr-2565
Sponsor: full_name: Rep. Buchanan, Vern [R-FL-16]
Introduced: 2021-04-15
Policy area: Health
Subjects: Animal protection and human-animal relationships

Cell biology and embryology

Computers and information technology

Drug safety, medical device, and laboratory regulation

Medical research

Medical tests and diagnostic methods

Research and development
Latest action: action_date: 2021-04-16
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2021-04-15
action_desc: Introduced in House
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, sophisticated computer modeling, and other human biology-based test methods.</p>

tv_txt: I 117th CONGRESS 1st Session 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 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. .