FDA takes steps to reduce animal testing requirements for monoclonal antibodies

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Key takeaways:

• The FDA plans to reduce and potentially replace animal testing for developing monoclonal antibody therapies and other medications.
• AI-based computational models are expected to play a larger role in drug development.

Animal testing requirements for monoclonal antibodies and other medications will be “reduced, refined or potentially replaced” in favor of other approaches, including artificial intelligence, according to a recent announcement from the FDA.

“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally,” FDA Commissioner Martin A. Makary, MD, MPH, said in a press release. “This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use.

“By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices,” he added. “It is a win-win for public health and ethics.”

According to the FDA, AI-based computational models could play a much larger role in the drug development process. In addition to being more humane than animal testing, the FDA’s statement argues these models could be more effective at predicting the way a drug will behave, describing potential toxicities and defining cell lines using New Approach Methodologies (NAMs) data.

The FDA additionally released a roadmap for using NAMs data as opposed to animal testing protocols to determine the efficacy and safety of medications. Implementation is set to begin “immediately” with investigational new drug applications.

“Over the coming year, the FDA aims to launch a pilot program allowing select monoclonal antibody developers to use a primarily non-animal-based testing strategy, under close FDA consultation,” read the statement, in part. “Findings from an accompanying pilot study will inform broader policy changes and guidance updates expected to roll out in phases.”

Use of lab-grown human organoids that mimic live human organs is also encouraged as an alternative to animal testing. This approach may reveal toxicities in human organs that might be missed in animal testing, according to the press release.

It is expected that these high-tech methods could expedite the drug development process, thereby lowering research and development costs and potentially reducing drug prices, the statement read.

The FDA said it will also offer incentives to increase uptake of these methods, including streamlined review processes.

For experts with questions, the FDA and its federal partners with the NIH, the National Toxicology Program and the Department of Veterans Affairs will hold a public workshop later this year.

According to Matthew R. Bailey, president of the National Association for Biomedical Research (NABR), efforts to minimize animal testing in drug development should be applauded.

However, in a statement released by the NABR in response to the FDA announcement, he urged caution in shifting to AI and other models too rapidly.

“We all want better and faster ways to bring lifesaving treatments to patients,” Bailey said in the statement. “But no AI model or simulation has yet demonstrated the ability to fully replicate all the unknowns about many full biological systems. That’s why humane animal research remains indispensable.”

According to the NABR, animal studies “remain essential” for understanding how medications could work in the complex biological systems of life.

“AI is incredible and promises to speed up many aspects of research,” Bailey said in the statement. “However, one of the problems with AI is that it largely depends on pulling from existing data. The unknown variables could present the biggest risk to patients. So, it will be interesting to see where AI is validated as a replacement to a whole biological organism and where it isn’t.”

On Dec. 29, 2022, then-President Joe Biden signed into law the FDA Modernization Act 2.0, allowing the FDA to pursue preclinical drug testing that included “non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or bioprinted or computer models.”

According to the NABR statement, the 2.0 measure “allows for the use of non-animal test methods where feasible, but it does not remove the need for animal testing.”

Another measure, the FDA Modernization Act 3.0 — intended to shore up implementation of the previous act — was introduced in Congress in early February 2024. It was later reintroduced in January 2025 but has yet to pass.

References:

FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs: https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs

NABR Responds to FDA’s Plan on Reducing Animal Testing: https://www.nabr.org/about-nabr/news/nabr-statement-fda-animal-testing