WASHINGTON, D.C. — Rep. Nanette Barragán (CA-44) Sept. 21 welcomed the U.S. Food and Drug Administration’s issuance of a direct final rule, which updates federal regulations to clarify scientifically appropriate non-animal methods can be used to evaluate the safety of drugs and biological products before they are tested in humans.
The FDA’s action follows bipartisan congressional efforts led by Rep. Barragán and Rep. Buddy Carter (R-Ga.) to ensure the agency fully implements the authority Congress established through the FDA Modernization Act 2.0. In April 2025, Barragán and Carter introduced the FDA Modernization Act 3.0, legislation requiring FDA to publish a final rule updating its regulations to reflect the availability of non-animal testing methods. The bill was cosponsored by Reps. Diana Harshbarger (R-Tenn.), Troy Carter (D-La.), Rosa DeLauro (D-Conn.), and Vern Buchanan (R-Fla.).
The FDA’s new rule updates terminology and removes language that could suggest animal testing is the only acceptable approach for generating safety information for human drugs and biological products. The agency said the rule recognizes a broader range of approaches, including methods involving human cells, organs-on-chips, computer models, and other New Approach Methodologies (NAMs).
The rule does not prohibit animal studies or change existing evidentiary standards. FDA stated that non-animal methods may be used when they are adequately validated and appropriate for the product and regulatory question.
The FDA’s action is being issued as a direct final rule and is subject to public comment.
Details: The full bill text can be found HERE.