Citizen Petition Filed Against FDA's Call for Animal Testing Alternatives

A citizen petition has been filed objecting to the FDA's recent call for alternatives to animal testing, arguing that it could lead to reliance on unvalidated methods and pose risks to human subjects. The petition suggests that the FDA's move to embrace alternatives may not be fully vetted and could jeopardize human safety. Moreover, it calls on the FDA to amend its regulations, publish a guidance document on non-animal methods, and incorporate encouragement for their use in existing and future guidance documents.
As background, on April 10, 2025, the FDA announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug evaluation” to fruition as outlined in a roadmap, FDA is offering pharmaceutical manufacturers incentives such as faster approval times and reduced testing requirements if they leverage emerging technologies that the agency believes hold the promise of cheaper, safer, and more ethical drug development processes.
The FDA’s sights are currently set on obviating the need for animal testing specifically in monoclonal antibody trials. However, the agency emphasized in the announcement its desire to expand its efforts to all future applicable use cases.
Opponents of animal testing have celebrated the FDA shift as a significant win. However, the fact is that such changes have been in the works for decades, as many research efforts in both the public and private sectors have focused on developing alternative testing technologies and models.
The petition asks that FDA stay its implementation of the April 10 policy, saying it should not be put into practice without a public comment period and an independent expert review of the proposed alternatives to animal testing. Without public comment, the organization says the change is a rulemaking that doesn’t follow the requirements of the Administrative Procedure Act.
Notwithstanding the petition, the FDA plans to host a public workshop later 2025 to discuss the roadmap and aims to launch the pilot program allowing select monoclonal antibody developers to use a primarily non-animal-based testing strategy.
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