But others cautioned against seeing the move as a major victory for animal rights advocacy. Naomi Charalambakis, director of science policy and communications at the organization Americans for Medical Progress, said the change in FDA’s policy isn’t sudden.

“It’s the latest step in a long, deliberate process driven by the scientific community’s ongoing commitment to implementing New Approach Methodologies (NAMs) where feasible, safe, and scientifically sound,” she wrote.

Charalambakis said regulators and scientists have worked for years on NAMs, and while advocates against animal testing are touting the move from FDA as a sweeping change, both animal testing and newer tools will continue to play a significant role in drug development.

“It’s also important to recognize that the FDA doesn’t dictate which data drug developers must submit — sponsors do,” she said. “Whether it’s animal data or NAM-based data, FDA evaluates what is provided. That’s why the real challenge lies in incentivizing and supporting sponsors to integrate NAMs into their workflows. Encouragingly, the FDA’s new roadmap begins to address this gap among other issues, though its timelines and goals don’t fully account for the hurdles scientists and developers still face in this space.”

FDA should remain in touch with the realities industry and scientists face in implementing NAMs, Charalambakis said, not move ahead of them.

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Published May 1, 2025 by Jessica Karins, InsideHealthPolicy