H.R. 2565House117th Congress (2021-2023)In Committee

FDA Modernization Act of 2021

AI-Generated Summary

Updated February 8, 2026 at 1:42 AM UTC

The FDA Modernization Act of 2021 amends the Federal Food, Drug, and Cosmetic Act to let drug manufacturers and sponsors use non‑animal testing methods when evaluating a drug’s safety and effectiveness. It replaces references to animal testing with the broader term “nonclinical tests or studies” and defines what counts as such. The change affects any company seeking FDA approval for a new drug and the agency’s review process.

Key Provisions

Replaces references to “animal” testing in Section 505 with the term “nonclinical tests or studies.”
Removes language requiring “animal or human studies,” substituting “nonclinical tests or studies” instead.
Adds a definition of “nonclinical test or study,” covering cell‑based assays, organ‑chip and microphysiological systems, sophisticated computer modeling, other human‑biology‑based methods, and animal tests.

Legislative Activity

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2 earlier actions

HouseCommittee Latest Action

Referred to the Subcommittee on Health.

Health Subcommittee

April 16, 2021

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HouseIntro Referral

Introduced in House

April 15, 2021

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

April 15, 2021

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

April 16, 2021

Bill Text

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Introduced in HouseIssued April 15, 2021

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.

Short title

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—

(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.