The HSUS

Tell the FDA: Make it clear that animal testing is not required!

Every day, countless dogs, monkeys, rats and other animals endure unimaginable suffering in painful experiments because of a flawed drug approval process. These animals spend their entire lives in barren laboratory settings, are forced to ingest—or are injected with—potentially toxic substances, suffer through various other painful and distressing procedures and are killed when the tests finally end.

Yet these tests not only inflict cruelty but also yield inaccurate results, with a staggering 90% of drugs that were deemed safe and effective in animal studies ultimately failing in human trials. It's time to put an end to this outdated and flawed system.

The U.S. Food and Drug Administration plays a key role in perpetuating these painful tests. The agency’s regulations and guidance documents encourage companies to conduct extensive animal tests to demonstrate that their drugs are safe and effective for humans. Drug companies know that animal tests are the easiest and fastest path to FDA approval despite the availability of new human cell-based test methods that could reduce animal use—while improving drug safety and efficacy—immediately.

That’s why we’ve taken action—filing a petition that urges the FDA to take concrete steps to make it clear that animal testing isn’t legally required and that companies are encouraged to replace animal tests with innovative non-animal methods whenever possible.

If we have any hope of replacing animal tests with more effective alternatives, the FDA must take immediate action.

But we need your voice to make a difference! Please take a moment to contact the FDA and urge them to adopt the important changes outlined in our petition!

TAKE ACTION
Please use the form to send a message to the FDA urging them to make the changes necessary to ensure that drug companies are encouraged to use non-animal alternatives instead of animal tests whenever possible!

This action alert is for U.S. residents. International advocates, please visit Humane Society International.

Your Message

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Decision Maker

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Dear Dr. Patrizia Cavazzoni,

I am writing to urge the U.S. Food and Drug Administration to adopt the changes outlined in the petition filed by the Humane Society of the United States and Humane Society Legislative Fund: 

1. Amend regulations to make it clear that the FDA does not require animal testing for drugs. 

2. Publish a new guidance document with detailed information about the non-animal test methods that can be used in place of animal tests. The document should be updated regularly as new methods become available.  

3. Commit to adding text to the top of all existing and future guidance documents for drugs that encourages companies to use non-animal methods whenever possible and links to the new guidance document with detailed information on non-animal methods that have been accepted by the agency.  

These requested changes align with the FDA’s publicly stated commitment to reduce animal testing and will provide the needed clarity about which non-animal methods can be used now and into the future. 

Animal tests are expensive, time consuming and not reliable predictors of human responses to drugs. In fact, approximately 90% of drugs deemed safe and effective in animal tests ultimately fail in human trials, with half of these failures attributed to unforeseen toxic reactions not observed in animal tests. 

In stark contrast, cutting-edge non-animal technologies, rooted in human biology, offer a more accurate and humane approach to predicting human responses to drugs. 

The suffering inherent in animal testing cannot be overstated. At one lab, a Humane Society of the United States investigator watched as several beagles who experienced fevers, tremors, rapid heart rates, labored breathing and unsteadiness following a high dose of a test substance were ordered to be dosed again, despite the dramatically harmful effects of the test substance. In another instance, the investigator comforted a dog as he lay dying on his kennel floor—hypersalivating, trembling, vomiting, moaning and unable to stand. The dog was not euthanized by the veterinarian until the following day. 

I support the FDA’s steps to reduce animal testing, including its request for funding to prioritize the reduction of animal testing, but there’s still more work to be done.  To benefit humans and animals, I urge the agency to act quickly and decisively to modernize drug testing in the way outlined in petition filed by the Humane Society of the United States and Humane Society Legislative Fund.

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