07/11/2025
So many wins for replacing animal testing shared today!
After many years working on this issue, I’m ecstatic to finally see mainstream acknowledgment of the need and benefits of replacing animal use, connected to clear action items.
My FDA highlights:
- Commissioner Marty Makary and Senior Advisor Tracy Beth Hoeg recognize scientific, business, and ethical advantages of nonanimal methods, and that replacing animal testing is a nonpartisan, unifying issue
- FDA will widely publish NAMs use cases
- FDA will provide clear agency policies on NAMs that industry can rely on, including clear and open regulations
- Short term, FDA will replace animals in skin irritation, pyrogen/endotoxin testing, certain batch and potency testing
- Strong leadership is bringing thoughtful people/opinions out of the woodwork with thoughtful solutions
- FDA will work at international level because many companies are global and will test for the least common denominator, ie, animal testing
- FDA and NIH will collaborate to utilize existing human data for better predicting safety in humans
My NIH highlights:
- DPCPSI Acting Director Nicole Kleinstreuer recognizes nonanimal methods as lasting solution to replacing animal use in research and testing
- NIH investment is shifting/reprogramming to methods rooted in human biology
- NIH will build up infrastructure and robust support for human-based science to combat entrenched animal use
- NIH will no longer seek proposals exclusively for animal models, all funding announcements will emphasize human-based methods
- NIH demonstrates issue with reviewers requiring animals even where sponsor seeks to avoid using animals, and calls for serious actions to stop assuming animal testing will be best predictive model because not clinically relevant
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