FDA and NIH Make Historic Shifts to Reduce Animal Testing

historic main building of the national institutes of health (nih)

In a landmark development for animal advocates, federal agencies continue to take concrete steps to reduce animal testing in scientific research. Two recent announcements signal major progress toward human-relevant, animal-free science.

FDA Commissioner Makes Bold Ethical Statement

On July 7th, the Food and Drug Administration (FDA) and National Institutes of Health (NIH) jointly hosted a workshop titled Reducing Animal Testing, during which Dr. Marty Makary, FDA Commissioner, made an unprecedented ethical declaration:

“God did not make animals on planet Earth for us to abuse and torture… we have to respect animals. This workshop is aimed at reducing animal testing in every way we can, while safeguarding the public with medications.”

This remarkable statement from a federal official at a scientific workshop attended by researchers, regulators, and policy experts represents a significant shift in the conversation around animal testing.

The event featured the release of FDA’s new Roadmap to Reduce Animal Testing in Preclinical Safety Studies, focusing on:

  • Publishing real-world use cases of non-animal methods to build confidence
  • Supporting regulatory pathways for human-relevant technologies
  • Ending exclusive funding for animal-based studies
  • Coordinating across agencies to accelerate the shift away from animal models

“In a room full of scientists and regulators, this ethically grounded message was as bold as it was unexpected,” said Dr. Lauren Stein, NAVS director of science and research programs. “Dr. Makary’s remarks—and the roadmap itself—reflect a growing consensus that modern science must evolve toward approaches that are not only scientifically superior, but also more humane.”

NIH Reforms Funding Policies to Include Human-Relevant Approaches

As of July 16, NIH has implemented a significant policy change: all new Notices of Funding Opportunity (NOFOs) that mention animal model systems must also include human-focused approaches, such as clinical trials, real-world data, and new approach methodologies (NAMs).

NIH will no longer issue funding opportunities that require specific animal models or focus exclusively on animal research. This opens doors for researchers developing human-relevant methodologies who previously might have been excluded from these funding streams.

“NIH is doing more than talking about human-relevant research,” said Dr. Stein. “They’re finally making space for it in how science gets funded.”

These developments mark measurable progress in shifting the scientific system toward one that values ethical and human-relevant approaches. They validate NAVS’ long-standing advocacy work and show that the priorities we champion—advancing science without harming animals—are beginning to be reflected in federal policy.

For those who have spent decades calling for an end to animal experimentation, seeing federal agencies not only acknowledge the harms of animal testing but begin replacing it with scientifically superior methods is a significant and validating moment. These changes signal that our advocacy efforts are working and that progress is not only possible, but underway.

The policy shifts also highlight the importance of programs like the graduate fellowships offered by the International Foundation for Ethical Research, which prepare the next generation of scientists to thrive in this changing landscape by supporting the development and implementation of human-based scientific methods.

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