By Sara Amundson and Kitty Block
In an era defined by scientific and technological innovation, testing drugs on dogs, rats, monkeys and other animals is not only becoming increasingly outdated but causes immense animal suffering. Despite publicly indicating a commitment to non-animal test methods, the U.S. Food and Drug Administration’s regulations and guidance documents for pharmaceutical companies are unclear and continue to emphasize the use of animals for drug testing. There is evidence that some companies believe testing on animals is legally required as part of the drug approval process.
That’s why we’ve filed a petition with the FDA today, requesting that the agency take a series of steps to make it plain and clear that animal testing isn’t legally required for drug approval and that the agency encourage companies to use non-animal methods when available. The FDA is legally required to consider and respond to our petition.
The petition asks the FDA to make the following changes to its regulations and guidance documents, which are documents that provide additional information on how to comply with its regulations:
- Amend its regulations to make it clear that the FDA does not require animal testing for drugs.
- Publish a new guidance document describing the non-animal test methods that can be used in place of animal tests. The document should be updated regularly as new non-animal methods become available.
- Commit to adding text to all existing and future guidance documents regarding the regulation of drugs. The new text should encourage companies to use non-animal methods whenever possible and refer them to the new guidance document on accepted non-animal methods.
Without these changes, the lack of clarity in FDA regulations will continue to perpetuate the status quo. That means tens of thousands of animals per year continue to suffer in archaic tests such as those we documented in an undercover investigation at a laboratory in 2022. The ambiguity surrounding whether animal testing is needed for drugs to gain approval is harmful in several ways. It creates confusion and discourages innovation. It may also negatively impact human health.
We all agree that the FDA has a responsibility to make sure that drugs intended for people are safe and effective. This is all the more reason why the agency should promote the use of data from non-animal test methods based in human biology; animal testing is not a reliable predictor of safety or efficacy in humans. Animal testing has acknowledged scientific limitations, but innovative non-animal technologies will only continue to improve. Emerging technologies such as organ-on-a-chip models offer promising approaches that are based on human biology and yield more reliable results.
We are not alone in our demand for the adoption of more humane testing methods. University centers devoted to non-animal methods are making the same case, and a pioneering 2007 National Research Council report spurred the creation of numerous governmental initiatives focused on the ultimate replacement of animals in toxicity testing. As a result of our longstanding political advocacy, Congress has also publicly supported and secured increased funding for alternatives to animal use. The time for change is now. You can help prevent countless animals from suffering by urging the FDA to update its drug testing regulations and embrace non-animal alternatives.
By supporting our petition to modernize the FDA’s drug testing regulations and guidance documents, you can help us create a future where compassion and scientific advancement go hand in hand.
Kitty Block is CEO of the Humane Society of the United States.
