Another Step In The Right Direction.
Repost: Physicians Committee for Responsible Medicine
Before a new medicine is tested in people, it goes through safety testing.
For decades, many of the federal regulations guiding that process referred specifically to animal tests.
That language is now changing.
On Sept. 21, the U.S. Food and Drug Administration announced it is updating numerous drug and biological product regulations to replace references to "animal tests" and "animal studies" with a broader term, "nonclinical." That term includes nonanimal methods such as tests using human cells, organs-on-chips, and computer models.
By no longer pointing specifically to animal testing, the updated rules clarify that drug developers can submit evidence from nonanimal methods where appropriate.
This change has been years in the making.
In 2017, Physicians Committee experts identified 235 FDA regulations that should be updated to remove barriers to nonanimal methods. Since then, the Physicians Committee has worked with Congress, the FDA, and drug developers to advance these changes.
"Changing a few words in federal regulations can have a significant impact," said Janine McCarthy, MPH, our director of research policy.
This is meaningful progress toward greater use of human-based methods in drug development, but the update covers only a portion of the FDA regulations that need modernizing.
We’ll continue working with the FDA to update remaining regulations and guidance, remove regulatory barriers, and accelerate the adoption of nonanimal methods that better protect people and animals.
For more information about our work to reform policies and advance animal-free science at the FDA, visit pcrm.org/FDAReform