USA: New Law Permits Animal-Free Testing

Animal-Free Methods Approved

For the first time in more than 80 years, a change in legislation in the USA enables animal-free testing of new drugs using modern, human-based methods.

The new law, signed by US President Joe Biden at the end of December 2022, allows the US Food and Drug Administration (FDA) to approve new drugs without requiring data from animal tests. Previously, pharmaceutical companies were legally obliged to test the safety and efficacy of their drug candidates in several series of trials on at least two animal species.

“A large body of data clearly demonstrates the failure of the outdated system based on animal testing. On average, 92% of drug candidates that have successfully passed all animal tests are later eliminated during clinical trials on humans, primarily because they are ineffective or cause significant side effects,” says Dr. Dilyana Filipova, scientist at Doctors Against Animal Experiments.

Human Mini-Organs Instead of Animal Testing

Thanks to the new law, modern human-relevant methods such as human mini-organs (“organoids”), multi-organ chips and computer-based procedures may in future be used in the USA in place of conventional animal testing for regulatory purposes. Many animal-free methods have already proven to be more accurate and reliable than animal tests.

“Such examples demonstrate the potential of this legislative change not only to spare countless animals from agonising experiments and a cruel death, but also to ensure greater safety for patients,” says Filipova.

Europe Must Follow Suit

However, animal testing is not prohibited under the new law and remains permitted as a possible testing system. Nevertheless, it is a tremendous step forward that pharmaceutical companies are no longer legally required to conduct these animal tests.

While the USA is introducing this modern, forward-looking legislation, animal testing in the EU — and therefore also in Germany — remains legally mandated for drug approval. «Europe must take the USA as a model as quickly as possible and stop requiring animal testing for the testing of medications,» says Filipova.

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