Path dependency and the rescuing of the biomedical research enterprise.

ABSTRACT: In 2025, three U.S. agencies within the Department of Health and Human Services (FDA, NIH, CDC) alongside EPA and the Departments of the Navy and Veterans Affairs, began substituting animal testing applications with reliable, human-relevant methods. The impact of this shift in public policy taking place at agencies historically bullish on animal testing is still reverberating in the United States and around the world. Here, we examine the circumstances that enabled such momentous reforms, including the role of the FDA Modernization Act 2.0 in advancing new alternative methods, collectively referred to as NAMs. We explain how animal testing, despite its poor value in predicting the safety and efficacy of drugs in humans, came to dominate drug discovery, basic sciences, and environmental tox

SUBMITTER: Nahle Z 

PROVIDER: S-EPMC12832638 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature