Trump Administration Pushes to End Animal Testing
Federal regulators working on behalf of the Trump Administration issued draft guidance to help manufacturers use alternatives to animal testing during drug development.
The Food and Drug Administration’s March 19 guidelines say in part that new approaches, such as using organoids—replica organs typically created with stem cells—and computer simulations can be used for preclinical toxicology and safety testing.
The FDA said it was offering the guidance to help developers “move away from reliance on animal testing.”
“This draft guidance advances our commitment to replace animal testing with human-relevant, scientifically rigorous methods,” Health Secretary Robert F. Kennedy Jr. said in a statement. “Clear validation expectations will help modern tools earn regulatory confidence and speed safer, more effective therapies to patients.”
Dr. Tracy Beth Hoeg, acting director of the FDA’s Center for Drug Evaluation and Research, added that it is time for the FDA to “shift the drug development paradigm away from the current default of using animals to predict human responses to one where these data are obtained through human-centric models which can more reliably, efficiently and ethically predict human drug reactions prior to clinical trials.”
Studies using phylogenetically lower animals, such as zebrafish, are also being encouraged.
The Trump Administration said in 2025 it would phase out animal testing for drugs and suggested that companies using alternatives could see their applications reviewed faster.
Dr. Marty Makary, the FDA’s commissioner, told The Epoch Times last year that animal testing is not good at predicting toxicity in humans and that adopting alternative approaches could lower costs for research, development, and capital, which would lead to lower drug prices.
The NIH said on March 18 it was investing some $150 million in research methods that better simulate human biology, such as computer-based methods, to reduce reliance on animal models.
The funding will establish centers designed to help drug makers develop new approach methodologies (NAMs).
“This is an exciting opportunity to create a repertoire of human-focused methods that are so sophisticated and comprehensive that successful clinical translation will rise and we will be able to answer questions beyond our reach with current research models,” Nicole Kleinstreuer, the NIH’s deputy director for program coordination, planning, and strategic initiatives, said in a statement.
“These new projects are key steps in expanding and strengthening our scientific toolbox. NIH’s investment in NAMs is critical to our mission to carry out gold-standard research.”
By Zachary Stieber | The Epoch Times News Service
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