In win for animals, the FDA takes new steps away from animal testing

When we recognized a straightforward way to address regulatory language at the U.S. Food and Drug Administration that could spare countless animals from suffering and dying in laboratories, we took action.  

We had been talking for years with pharmaceutical manufacturers whose representatives claimed the lack of clarity in the FDA's regulations created confusion around the requirements for animal testing. Of course, we had been discussing our own concerns about these regulations with the FDA itself. In an effort to eliminate the ambiguity involved, we filed a legal petition with the FDA to urge the agency to make it absolutely clear to pharmaceutical companies that using animals to test new drugs is not required.  

Hundreds of thousands of our supporters agreed and contacted the FDA to show their support for this simple, commonsense change.  

Today, there’s been a breakthrough: The FDA announced that it plans to update its drug regulations by removing references to animal testing. This will help make it clear that companies don’t have to submit data from animal tests to have their drugs approved.  

It’s a straightforward solution, but one that will eventually have substantial implications for millions of animals used in testing. And because the U.S. is the world’s largest pharmaceutical market, what the FDA does has consequences for animals in laboratories all over the world. 

Hastening the end of animal testing 

Over the last few years, we’ve seen major shifts away from using animals in experiments throughout the U.S. But despite this momentum, those of us who have been dedicated to ending animal testing and research have been very aware of ambiguity in the very language that regulates and directs testing that, in effect, slows or even prevents tangible progress away from animal testing.  

The FDA has been a locus for some of this ambiguity. On the one hand, the agency was encouraging companies to shift away from using animal testing data when submitting drugs to the agency for approval. But at the same time, the industry was hesitant to make this shift because the FDA’s own regulations still suggest that the agency required data from animal tests in certain situations to approve new drugs.    

That’s why today’s announcement is a critical step toward ensuring that companies understand that they can use and present data and evidence from methods such as organ-on-a-chip technology, advanced computational models and AI-driven simulations—to test the safety and efficacy of their products and meet the demands of the FDA’s drug approval process.  

This step signals the beginning of the end of harming animals to test drugs. And it is just one breakthrough among many. The next step is ensuring that what’s on the books translates to an actual reduction of animals used in research and testing.   

Making animal testing the exception 

Since announcing in April 2025 that it planned to make animal testing “the exception rather than the norm” by 2030, the FDA has taken other steps to phase out pharmaceutical tests on animals.  

Last October the agency updated its website to include an inventory of methods that drug companies can use to reduce or eliminate animal tests. In December, the agency took steps to reduce—and in some cases eliminate—certain tests on monkeys. And in March 2026, it released a guidance document encouraging drug companies to use cutting-edge non-animal technologies whenever possible. 

In addition, last month the FDA announced that it had completed a pilot program with its international counterparts that could help streamline the process for companies that want to switch from horseshoe crab blood-based testing to a non-animal test for products that are already approved. This is a promising step. 

Testing drugs on animals doesn’t work—but there is a better way 

We know that testing drugs on animals causes immense suffering. We also know that it doesn’t work. Over 90% of drugs that appear successful in animal tests go on to fail in human clinical trials. Part of the reason these animal tests are so unreliable is that humans are so biologically different from other animals. Continuing to rely on these tests decade after decade is hindering medical progress and likely the emergence and approval of lifesaving medical treatments for millions of people.  

Animal tests are no match for new methods that use human data, tissues and cells. Because they’re based on how the human body works, these cutting-edge test methods provide more accurate and efficient insights into how drugs affect people. They also highlight the advantages of technology that wasn’t available decades ago, when many of the animal tests in use today were developed. It’s simply better, more modern science.  

This is why we are so pleased that the FDA is taking decisive steps to update the outdated drug approval process, which will not only embrace new and innovative science that is better for both humans and animals but will accelerate its adoption and implementation.  

What’s next and how you can help bring an end to animal testing 

First, we need to ensure that the FDA implements these updates to its regulations as quickly as possible so that it’s clear that animal testing is not required. We are also urging the agency to:  

• Broaden and expand the preliminary recommendations released in March to include detailed information about the non-animal test methods that can be used in place of animal tests for drug approval and commit to updating the document regularly as new non-animal methods become available.  
• Add language that encourages companies to use non-animal alternatives whenever possible to all existing and future guidance documents related to the regulation of drugs, with accompanying links to the latest guidance document on accepted non-animal tests.   

In the wake of this encouraging announcement by the FDA, we’re going to redouble our efforts to press companies to move away from animal tests and commit to the submission of data from non-animal methods for the drug approval process. Right now, we need your help to push the agency to implement these updates in their regulations as quickly as possible so that it’s clear that animal testing is not required.