Impact On Product Development: FDA Phasing Out Animal Testing Requirement

By Mike Fusakio, Ph.D., and Hema Balasubramanian

The FDA is embarking on a transformative initiative to phase out animal testing requirements, driven by the 2022 FDA Modernization Act 2.0 and a growing commitment to non-animal alternatives. Their "Roadmap to Reducing Animal Testing in Preclinical Safety Studies" delineates a strategic, phased approach, beginning with monoclonal antibodies and leveraging New Approach Methodologies (NAMs) such as in vitro systems, computational modeling, and ex vivo human tissue assessments.

Over the next three years, the FDA plans to review existing data, collaborate with sponsors on NAM studies, and establish an open-access repository for drug toxicity data. While these advancements signal a significant shift in regulatory practices, they remain in development, necessitating early engagement from sponsors to navigate the implications for their products. These innovative practices present a promising alternative to traditional animal testing, potentially expediting the journey to clinical trials while also prompting sponsors to consider the acceptance of these changes by international regulatory bodies.