S. 4288Senate117th Congress (2021-2023)In Committee

Reducing Animal Testing Act

Introduced May 19, 2022

AI-Generated Summary

Updated February 8, 2026 at 3:34 PM UTC

The Reducing Animal Testing Act would let drug manufacturers and sponsors use non‑animal testing methods when evaluating the safety and effectiveness of biological products. By expanding what kinds of studies can be used for toxicity assessments, the bill aims to cut back on the use of animals in drug development.

Key Provisions

  • Amends the Public Health Service Act to add language allowing toxicity assessments to rely on alternative (non‑animal) studies described elsewhere in the law.
  • Explicitly permits manufacturers and sponsors to use these alternative testing methods instead of animal testing for biological products.

Legislative Activity

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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

May 19, 2022

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SenateIntro Referral

Introduced in Senate

May 19, 2022

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

May 19, 2022

Bill Text

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Introduced in SenateIssued May 19, 2022

II

117th CONGRESS

2d Session

S. 4288

IN THE SENATE OF THE UNITED STATES

May 19 (legislative day, May 17), 2022

Mr. Luján introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To allow manufacturers and sponsors of a drug to use alternative testing methods to animal testing to investigate the safety and effectiveness of a biological product.

1.

Short title

This Act may be cited as the Reducing Animal Testing Act.

2.

New approach methodologies

Item (bb) of section 351(k)(2)(A)(i)(I) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)(i)(I)) is amended to read as follows:

(bb)

an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and

.