S. 5002Senate117th Congress (2021-2023)Passed Senate

FDA Modernization Act 2.0

Sponsored by Rand PaulSen. Rand Paul (R-KY)
Introduced September 29, 2022

AI-Generated Summary

Updated February 8, 2026 at 5:57 PM UTC

The FDA Modernization Act 2.0 updates federal drug law so that companies can use non‑animal testing methods when applying for approval of drugs and biologics. It changes the language in the FD&C Act to refer to “nonclinical tests” and defines that term to include in‑vitro, computer‑based, and other non‑animal methods as well as traditional animal tests. The bill also revises biosimilar product rules to let toxicity assessments rely on these nonclinical studies. It mainly affects drug developers, biotech firms, and the FDA.

Key Provisions

  • Replaces “preclinical tests (including tests on animals)” with “nonclinical tests” in the FD&C Act.
  • Adds a definition of “nonclinical test” that covers in‑vitro, in‑silico, in‑chemo, and non‑human in‑vivo tests, including but not limited to animal studies.
  • Allows the FDA to accept toxicity assessments for biosimilar products that are based on the newly defined nonclinical tests.

Legislative Activity

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4 earlier actions
HouseFloor Latest Action

Held at the desk.

September 29, 2022 • 6:51 PM

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SenateIntro Referral

Introduced in Senate

September 29, 2022

SenateFloor

Introduced in the Senate, read twice, considered, read the third time, and passed without amendment by Unanimous Consent. (consideration: CR S5514-5515; text: CR S5514-5515)

September 29, 2022

SenateFloor

Message on Senate action sent to the House.

September 29, 2022

HouseFloor

Received in the House.

September 29, 2022 • 3:59 PM

HouseFloor

Held at the desk.

September 29, 2022 • 6:51 PM

Floor Debate

1 member

What members said about S. 5002 on the floor

1 Republican
Rand Paul
Sen. Rand PaulR-KY · Sep 29, 2022

Mr. President, I rise today to talk about a bill that would lift a mandate in the law dating back to the Great Depression. This mandate is that drugs have to be tested on animals before clinical…

Bill Text

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Latest
Engrossed in SenateIssued September 29, 2022

117th CONGRESS

2d Session

S. 5002

AN ACT

To allow for alternatives to animal testing for purposes of drug and biological product applications.

1.

Short title

This Act may be cited as the FDA Modernization Act 2.0.

2.

Alternatives to animal testing

(a)

In general

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—

(1)

in subsection (i)—

(A)

in paragraph (1)(A), by striking preclinical tests (including tests on animals) and inserting nonclinical tests; and

(B)

in paragraph (2)(B), by striking animal and inserting nonclinical tests; and

(2)

after subsection (y), by inserting the following:

(z)

Nonclinical test defined

For purposes of this section, the term nonclinical test means a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or bioprinted or computer models.

.

(b)

Biosimilar biological product applications

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

.

Passed the Senate September 29, 2022.

Secretary