USA aims for drug testing without animal experiments
- Press release
Paradigm shift toward faster, more affordable development of better medicines
The U.S. Food and Drug Administration (FDA) has announced plans to replace animal testing in the development of therapeutic antibodies and other drugs with more effective, human-relevant methods. The goal is to promote public health, improve drug safety, and accelerate the development process. At the same time, development costs are to be reduced, animal testing significantly decreased, and medication prices lowered. The German organization Doctors Against Animal Experiments calls this a groundbreaking development and warns: Germany risks falling behind.
With a recently published roadmap (strategic plan), the FDA is facilitating the use of modern, animal-free methods—known as New Approach Methodologies (NAMs), including AI-based computer models and organoids. These are intended to gradually replace animal testing in drug safety assessments.
The background to this decision is the sobering realization that over 90% of drugs that appear safe and effective in animal tests fail in humans due to lack of efficacy or unexpected side effects. Animal testing is particularly unreliable for therapeutic antibodies, as biological differences between animals and humans prevent the prediction of potential immune reactions.
"The introduction to the roadmap reads almost like a position paper from our organization," says Dr. Johanna Walter, scientific advisor at Doctors Against Animal Experiments. "Even more encouraging, however, are the concrete measures and the short timeframes in which a significant reduction in animal testing is to be achieved."
Over the next three years, the FDA plans to drastically reduce animal testing for toxicity assessment through targeted measures. These include, among other things, the use of existing data (including from abroad) and the creation of a comprehensive toxicity database to support the development and validation of computer models. Companies that submit results from animal-free methods may be allowed to forgo a portion of the previously required animal tests, thereby speeding up the approval process for their drugs.
The goal is for animal testing in the safety assessment of therapeutic antibodies to be conducted only in exceptional cases within the next three to five years, while animal-free testing becomes the norm. The strategy, initially focused on therapeutic antibodies, is to be gradually expanded to include other classes of drugs, ultimately leading to fully animal-free safety testing for all medications.
Although animal testing is not entirely ruled out under this strategy, the roadmap creates a clear incentive for the pharmaceutical industry to adopt more reliable and cost-effective animal-free methods and to move away from animal testing. “No company is interested in investing time and money in experiments that provide no relevant insights for humans. This new strategy clearly demonstrates that NAMs are not only ethically preferable, but scientifically and economically advantageous,” says Walter.
With the roadmap, the FDA also aims to position itself as a global leader in modern, scientifically grounded, and innovation-friendly regulation. The European Commission has also sent clear signals for an animal-free future with the development of a roadmap for phasing out animal experiments in chemical testing.
Germany, on the other hand, is still waiting for the reduction strategy for animal testing announced by the outgoing government, whose implementation is uncertain following the upcoming change in government. Doctors Against Animal Experiments sees the risk that, without swift action, Germany will fall behind in the development of future-proof medicines.
References
Roadmap to reducing animal testing in preclinical safety studies, FDA, 10.04.2025 >>
Animal-free chemical testing in the EU, Doctors Against Animal Experiments, 24.03.2025 >>