Federal Agencies Signal Intent to Limit Animal Research

By: Galen Cobb
Thursday, April 24, 2025
On April 10, the Food and Drug Administration (FDA) announced it would no longer require animal testing data for monoclonal antibodies in Investigational Novel Drug (IND) applications – the regulatory requirement for initiating a clinical trial. Accompanying this announcement, FDA released its Roadmap to Reducing Animal Research in Preclinical Safety Studies, which outlines a plan to prioritize research conducted using novel alternative methods (NAMs) in approving IND applications. 

During a cabinet meeting, Department of Health and Human Services Secretary Robert F. Kennedy Jr. made comments indicating a potential forthcoming directive to replace animal research at the National Institutes of Health and FDA with artificial intelligence (AI) technology.

In 2019, the Environmental Protection Agency (EPA) issued an agency-wide directive to end animal research by 2035. While this directive was subsequently reversed during the Biden administration, a report in the Washington Examiner attributed to EPA spokeswoman Molly Vaseliou indicates support for reinstating the directive from the current EPA Administrator, Lee Zeldin. However, EPA has not released an official statement, nor is the original 2019 memo currently available.

FASEB continues to track policy changes in the agencies that affect animal research.