Humane World for Animals

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 distressing and often painful experiments because of an ineffective 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 invasive procedures and are typically killed when the tests finally end. 

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 It's time to put an end to this outdated and scientifically flawed system. 

Thankfully, in March 2026, the Food and Drug Administration (FDA) released preliminary recommendations encouraging drug companies to use innovative non-animal technologies whenever possible.

We are excited to see the FDA take this step, but we need your help to ensure that the agency strengthens and broadens the proposal in their recommendations. And, if they really want to the pharmaceutical industry to use non-animal methods, the FDA must make changes to their regulations to make it absolutely clear to companies that animal testing is not legally required to test drugs!

We need your voice to make a difference. Please take a moment to contact the FDA and hold them accountable!

TAKE ACTION

Please use the form to send a message to the FDA urging them to do everything they can to ensure that drug companies use non-animal alternatives instead of animal tests whenever possible!

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Dear Commissioner, 

I am writing to thank the U.S. Food and Drug Administration for releasing draft guidance that makes it clear to drug companies that they should submit data from innovative non-animal technologies whenever possible.   

In order to make this commitment a true reality that protects animals, I urge you to strengthen and broaden this guidance to avoid the sole focus on validation in its current form and to specify non-animal methods accepted by the agency on a regular basis. Further, to see industry actually begin submitting non-animal data, FDA must make the changes outlined in the agency’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies and in the petition filed by Humane World for Animals and Humane World Action Fund in the regulations. 
 
Specifically:  

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

2. Broaden and expand this draft guidance document to include 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. 

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

In contrast, animal tests are no match for cutting-edge non-animal technologies like advanced human cell-based systems and computational models. Because they’re based on how the human body works, these sophisticated methods can provide more accurate and efficient insights into how drugs affect people. It’s simply better, more advanced science—and it doesn’t harm animals. 

The suffering inherent in animal testing cannot be overstated. At one lab, a Humane World for Animals 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. This is just one example of what is happening to animals in laboratories around the country on a daily basis.  

I support the FDA’s steps to reduce 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 ways outlined in the petition filed by Humane World for Animals and Humane World Action Fund.  

Thank you for your consideration.

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