It is a major success. For the first time in more than 80 years, a change in U.S. law will allow new drugs to be tested using modern, animal-free, human-based methods. Eurogroup for Animals welcomes this huge step forward and calls on the EU to follow suit by developing and implementing a strategy for human-relevant drug development without animal testing.
The new law, signed by U.S. President Joe Biden at the end of December 2022, allows the U.S. Food and Drug Administration (FDA) to approve new drugs without requiring animal data. Previously, pharmaceutical companies were required by law to test the safety and efficacy of their drug candidates in multiple animal studies, including toxicity tests on one rodent species such as a mouse or rat, and one nonrodent species such as a monkey or dog, before testing the drug candidates in human clinical trials.
"A large amount of data clearly demonstrates the failure of the outdated system based on animal testing. On average, 92% of drug candidates that successfully pass all animal tests are later abandoned during human clinical trials, mainly because they do not work or cause significant side effects." Dr. Dilyana Filipova, scientist at Doctors Against Animal Experiments
Thanks to the new law, modern, human-relevant approaches, such as human mini-organs ("organoids"), organ-on-a-chip and computer-based methods can now be used for regulatory purposes in the U.S. instead of standard animal test methods. Many non-animal methods have already been shown to be more accurate and reliable than animal testing. For example, a recent study used a human-liver-chip to demonstrate the toxicity of several liver-damaging compounds, whereas previous animal tests had incorrectly classified the same compounds as harmless.
"Such examples show the potential of this legislative change to not only save countless animals from barbaric testing and a cruel death, but also to ensure better safety for patient." Dr. Dilyana Filipova, scientist at Doctors Against Animal Experiments
However, animal testing is not banned under the new law and is still allowed as a possible testing approach. Nevertheless, it is a huge step forward that pharmaceutical companies will no longer be legally obliged to conduct animal tests, and will be free to use accurate, human-relevant, non-animal methods.
While the U.S. is introducing this modern, forward-looking legislation, some animal testing is still required by law for drug approval in the EU.
"Europe must follow the example of the U.S. as soon as possible, and end the use of animals in drug testing. If we want to develop better therapies and not fall behind in the global drug market, we should also rely on the most modern, successful and reliable human-based methods and not on pointless animal testing." Dr. Dilyana Filipova, scientist at Doctors Against Animal Experiments