United States – The Humane World Action Fund revealed the results of an approximately seven-month undercover investigation at Inotiv, an animal testing laboratory in Indiana where thousands of animals are killed every year.

The organization said it is encouraged by new draft guidance from the U.S. Food and Drug Administration aimed at reducing testing on non-human primates for monoclonal antibody therapies and will be submitting comments.

Monoclonal antibodies are laboratory-made proteins designed to mimic the human immune response with precise specificity. They are often developed for cancer and autoimmune diseases and can be engineered to bind only to targets found in people, block tumor growth, deliver treatment directly to diseased cells, or adjust immune activity.

“We’re encouraged that this draft guidance, which if adopted will decrease the number of primates used for testing, reflects the FDA’s stance that non-animal methods can deliver better, more reliable data for drug therapies. We urge FDA to take additional, meaningful steps so that more humane, science-driven methods become the norm rather than the exception, as FDA has stated it is seeking,” said Kathleen Conlee, vice president, Animal Research Issues at Humane World for Animals.

“Saving human lives doesn’t need to come at the expense of animals’ lives. We welcome today’s announcement by the FDA and will continue our longstanding advocacy including encouraging FDA to grant our regulatory petition seeking clarification for the use of modern, humane alternatives across the board,” said Tracie Letterman, vice president, Federal Affairs at Humane World Action Fund.

Humane World for Animals and Humane World Action Fund have for years pressed the FDA to prioritize non-animal testing methods. Their regulatory petition asked the agency to clarify that animal testing is not legally required under the Federal Food, Drug, and Cosmetic Act and requested a guidance document focused on non-animal methods.

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