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# Researchers Urge FDA Caution in Phasing Out Animal Testing
- URL: https://www.fdaweb.com/researchers-urge-fda-caution-in-phasing-out-animal-testing/
- Published: 2026-02-12T12:00:00.000Z
- Updated: 2026-09-14T13:33:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160656

A new academic paper is urging FDA to proceed cautiously as it moves to phase out animal testing in drug development, warning that an overly rapid transition to newer technologies could create safety and effectiveness risks. The [article](https://www.cell.com/trends/biotechnology/fulltext/S0167-7799%2825%2900532-3?%5FreturnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0167779925005323%3Fshowall%3Dtrue&ref=fdaweb.com), published in the journal *Trends in Biotechnology*, examines FDA’s recent commitment to replace animal testing in the development of monoclonal antibodies and certain other drugs with alternative approaches such as artificial intelligence-based computational models and laboratory systems known as “organs-on-a-chip” or organoids that mimic human tissues.

Co-author **Sara Gerke** says the agency’s goals are ambitious but may be premature given the current state of the science. “The primary goal of the FDA is to make animal testing the exception in three to five years, and a secondary goal is to get drugs to the market faster by reducing research and development costs,” Gerke writes. “Those are worthy goals, but it’s hard not to worry about the attendant risks. We need to think carefully about how to validate these new methodologies so they are at least as effective as animal testing.”

FDA’s shift follows the passage of the FDA Modernization Act 2.0 in late 2022, which opened the door to non-animal testing alternatives. Last April, the agency announced plans to begin moving away from animal testing for certain drugs and to encourage use of what it calls “New Approach Methodologies,” or NAMs. It has outlined a stepwise strategy to reduce reliance on animal studies in preclinical safety testing, contingent on scientific validation of the alternative methods.

The agency has also said it will update guidance documents and offer streamlined review pathways for sponsors that submit strong safety data derived from non-animal approaches, in an effort to incentivize their adoption.

But the paper’s authors argue that many NAMs “are currently not yet ready for prime time.” They note the absence of robust noninferiority or superiority studies demonstrating that the new methods perform as well as, or better than, traditional animal models in predicting human safety outcomes.

For example, AI-driven models can be susceptible to bias, Gerke says, and would require careful ethical design and systematic bias screening. Organ-on-a-chip and organoid systems, while promising, still require additional validation to establish their predictive reliability across specific contexts of use.

The authors suggest several guardrails, including a possible FDA premarket review process or independent third-party certification system for NAMs. Another option would be for drug developers to run animal studies in parallel with alternative methods until sufficient comparative data are generated to demonstrate that the new approaches are at least as reliable in assessing toxicity and safety.

“Making animal studies the exception rather than the rule within the next few years is likely overly optimistic given the current evidence,” Gerke says.

While the authors acknowledge the ethical and economic appeal of reducing animal testing — including the potential to lower research costs and alleviate animal suffering — they conclude that scientific validation must precede broad regulatory substitution. “There’s certainly potential for new methodologies to become an important tool for reducing animal testing,” Gerke said. “With that said, rigorous validation is essential, and we’re just not there yet.”

The paper’s research was funded by the National Institutes of Health and the National Institute of Biomedical Imaging and Bioengineering.