FOR IMMEDIATE RELEASE
September 23, 2026
Contact: Jin.Choi@mail.house.gov
WASHINGTON, D.C. — On Monday, Congresswoman Nanette Barragán (CA-44) 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.).
“Modern science is giving us better tools to understand how medicines affect people, and our laws and regulations need to keep pace,” said Congresswoman Nanette Barragán. “I’m proud to have worked across the aisle to advance the FDA Modernization Act 3.0 and help ensure that FDA’s regulations reflect the scientific tools available today. This action is an important step toward giving researchers greater flexibility to use validated methods that can improve drug development while maintaining rigorous safety standards.”
“This is a long-delayed but highly consequential move by FDA to bring drug-development regulations into the 21st century,” said Wayne Pacelle, president of the Center for a Humane Economy and Animal Wellness Action. “The agency knocking down outdated regulatory language propping up ineffective animal testing strategies put new methods rooted in human biology. Over time, we’ll see better, safer, less costly drugs that help people struggling with disease.”
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.
The full bill text can be found HERE.
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