The US Food and Drug Administration (FDA) announced plans to reduce, refine, or replace animal testing for investigational new drug (IND) applications involving monoclonal antibodies and other drug candidates. The agency aims to leverage a suite of new approach methodologies (NAMs), including computational models, human cell lines, and organoids.
Instead of relying on animal testing, the FDA plans to use pre-existing real-world safety data from other countries where the drug has already been studied in humans. The agency expects to phase out animal testing over time, with a pilot program launching this year that will involve certain drugmakers using non-animal methods to test antibodies in close consultation with the FDA.
While some experts welcome the move, others have expressed concerns about the limitations of alternative methods and the need for more robust validation. The National Association for Biomedical Research (NABR) notes that current AI models and simulations cannot fully replicate all unknowns about biological systems, but is prepared to work with the FDA to ensure patient safety.
The FDA’s decision aligns with its commitment to replace animal testing, which has been supported by both Congress and various advocacy groups. The agency has already implemented some of these changes, including allowing for non-animal test methods in preclinical drug testing. A new bill pending in Congress aims to further expedite the adoption of alternative methods.
As the FDA moves forward with its plans, it is clear that a significant shift towards alternative approaches is underway. While challenges remain, this development holds promise for accelerating cures and meaningful treatments for Americans while reducing animal use.
Source: https://www.fiercebiotech.com/cro/fda-announces-plan-end-animal-testing-requirements-monoclonal-antibody-drugs