FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
The U.S. Food and Drug Administration (FDA) has announced a significant initiative aimed at modernizing preclinical drug safety evaluations by phasing out the requirement for animal testing in the development of monoclonal antibody therapies and potentially other drug types. This strategic shift, detailed in a recent press announcement, reflects the agency's commitment to advancing public health through the adoption of more effective and human-relevant testing methodologies. The FDA intends to reduce, refine, or replace traditional animal studies by promoting the use of innovative approaches such as artificial intelligence (AI)-based computational models for toxicity prediction and laboratory-based methods that mimic human biology, including cell lines and organ-on-a-chip systems, also known as New Approach Methodologies (NAMs).
The FDA's decision is driven by the increasing recognition of the limitations associated with animal models in accurately predicting human responses to certain therapeutics. The agency believes that these new, human-relevant methods hold the potential to improve drug safety assessments and accelerate the overall evaluation process. Furthermore, the FDA anticipates that this transition could lead to a reduction in the costs associated with research and development, and ultimately contribute to lower drug prices. The implementation of this new approach will begin immediately for investigational new drug (IND) applications, where the inclusion of NAMs data is being encouraged.
To facilitate this transition, the FDA plans to collaborate with other federal agencies, including the National Institutes of Health (NIH) and the National Toxicology Program. The agency will also work through the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to drive the validation and broader adoption of these novel methodologies. Additionally, the FDA is planning to launch a pilot program specifically for monoclonal antibody developers to utilize primarily non-animal-based testing strategies under close agency consultation. Findings from this pilot study are expected to inform future policy changes and the development of updated guidance documents in a phased approach.