S 355introduced119th Congress

FDA Modernization Act 3.0

Introduced Feb 3, 2025Senate billPolicy area: HealthLast action Dec 17, 2025Sponsor: Cory A. Booker(D-NJ)

healthcareHealth

Health, Education, Labor, and Pensions Committee

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Official summaryUpdated Dec 17, 2025

What the bill does

FDA Modernization Act 3.0 This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug. The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications, and may make other changes to the regulations as appropriate. The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.

Latest official action

Held at the desk.

Lobbying Filings

$867.6M

Total Lobbying Spend

Suspicious Trades

Members Involved

Timeline

Feb 3, 2025bill

Bill introduced

Apr 18, 2025lobbying

Lobbying filed by FRAGRANCE CREATORS ASSOCIATION

Jul 17, 2025lobbying

Lobbying filed by CONSUMER HEALTHCARE PRODUCTS ASSOCIATION

Jul 21, 2025lobbying

Lobbying filed by PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

Jul 21, 2025lobbying

Lobbying filed by FRAGRANCE CREATORS ASSOCIATION

Jul 21, 2025lobbying

Official Congressional Actions

Dec 17, 2025Floor

Held at the desk.

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Dec 17, 2025Floor

Received in the House.

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Dec 17, 2025Floor

Message on Senate action sent to the House.

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Dec 16, 2025Floor

Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)

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Dec 16, 2025Floor

Lobbying Activity

Registrant	Client	Amount	Filed	Period	Issues
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA	PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA	$758.0M	Jul 21, 2025	2025Q2	BUDCPTHCR
FRAGRANCE CREATORS ASSOCIATION	FRAGRANCE CREATORS ASSOCIATION	$21.0M	Apr 18, 2025	2025Q1	CSPCHMTAX

Suspicious Trading Activity

Congress members who traded stocks in companies connected to lobbying on this bill, within 90 days of its introduction date.

No suspicious trade-lobbying connections found for this bill.

Methodology: Bill-Lobbying-Trade Connection

CapitolExposed identifies the "bill-lobbying-trade pipeline" by: (1) finding lobbying filings (LD-2) that specifically mention this bill, (2) matching lobbying clients to publicly traded companies, and (3) finding stock trades by members of Congress in those companies within 90 days of the bill's introduction date. Trades made before the bill was introduced are highlighted in red, as they may indicate advance knowledge. This analysis surfaces correlations worthy of scrutiny; it does not prove wrongdoing.