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U.S. Food and Drug Administration embarks on a goal to move away from animal testing

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A recent article in Nature magazine examined the U.S. Food and Drug Administration (FDA)’s commitment to advancing alternative methods capable of replacing animal testing in new drug and product development.

The article states, “The future of drug development might be animal-free - or, at least, involve far fewer animals than is currently the norm. Last June, the U.S. Food and Drug Administration (FDA) set out proposals for the New Alternative Methods Program that will focus on replacing, reducing and refining the use of laboratory animals through the adoption of cutting-edge alternative methods. The aim is to produce findings that are more relevant to humans, streamline product development and reduce costs.”  

This shift, as the article acknowledges, follows years of pushing from animal advocacy organizations like Cruelty Free International that have long been calling for an end to animal testing in favor of modern animal-free research and testing.

Cruelty Free International has been campaigning for the FDA to Make Alternatives a Priority, by eliminating requirements for animal tests and updating its regulations to make clear that non-animal methods can and must be used whenever possible.

FDA regulations and guidance, particularly in drug development, are behind-the-times and often allow, lead to, or require the use of animal tests even when methods that do not use animals or additional animals are available. As a result, companies may be forced to conduct animal tests, or they may choose animal tests even when non-animal methods are available because they view them as the most secure route to regulatory approval.

FDA officials now say that their alternatives program is, in fact, a priority and have requested $5 million dollars in the 2023 budget to develop a ‘comprehensive strategy’ on alternative testing methods.

Our North America Head of Public Affairs, Monica Engebretson said, “I find the stated level of commitment to animal-free research and testing now being signaled by the FDA backed by a financial investment a very promising step forward. By making alternatives a priority the FDA can ensure that cutting-edge technologies that can replace animal tests and better predict human responses are accepted and used whenever available. This will deliver safer and more effective medicines, more quickly and at less cost, and save both human and animal lives.

“We look forward to monitoring the progress of the program so that we accelerate the move from commitments to tangible results for animals.”

The Nature article also reinforced how important our international approach is to achieving an end to animal testing. The article noted, for example, that the FDA’s interests in pursuing new approaches follows moves such as the European Parliament’s vote in 2021 in favor of accelerating the transition to animal-free research, testing and education.

Engebretson added, “The pharmaceutical, chemical, and cosmetics industries are international and will have to continue to use animal tests until the last economically significant country no longer requires animal testing. As the first and only international organization focused on ending animal testing around the world, our work to harmonize international regulations so that modern, humane, and human-relevant tests are accepted, and outdated animal tests eliminated everywhere, is crucial.”

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