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Facts about FDA and Animal Welfare, Testing & Research 


A research scientist observes a research animal.

Medical and veterinary products save lives every day in the U.S. FDA-regulated products like blood pressure medicine, chemotherapy, and MRI machines help people and animals live longer and healthier. The FDA regulates human and animal medical products to ensure they are safe and effective. 

Products undergo different types of testing to determine their safety and effectiveness. These tests may include animal testing, and almost always include other types of tests. Here are some facts about animal testing of FDA-regulated medical products and alternatives to animal testing.     

Fact: The FDA encourages and accepts scientifically valid alternatives to animal testing. However, validated alternatives to animal testing are not available yet for many medical products.

More Information: Product developers must show the FDA that a medical product is reasonably likely to be safe for testing in people. Only scientifically reliable and validated test methods can be used to show product safety before testing in people.
These types of tests are generally referred to as nonclinical tests. There are many types of nonclinical testing, for example:
  • Laboratory tests in a petri dish or test tube, which may include tests with human or animal cells and tissues. 
  • Computer modeling. 
  • Animal testing. 
Testing a product with people is called clinical testing. A product developer collects scientific information from nonclinical testing to show that clinical testing in people is likely to be safe. After the nonclinical testing phase, the FDA may authorize the product developer to conduct clinical testing.
Product developers who are seeking FDA approval must show that a new medical product is safe and effective for its intended use. Product developers determine which types of tests they will conduct, in consultation with the FDA. Often, product developers conduct animal testing at some stage of the product development process because scientifically valid alternatives to animal testing are not available yet.
Bottom Line: Product developers can use alternative methods to animal testing. The law requires product developers to submit scientific information showing that a medical product is reasonably safe for clinical testing, also known as clinical investigation or clinical trials, before investigating the product in people.

Fact: The FDA supports the development of alternatives to animal testing.  

More Information: The FDA supports industry efforts to develop and use alternative methods to test the safety of FDA-regulated products. We believe that before researchers use animals for testing, they should consider using scientifically valid alternatives. The FDA has provided guidance to product developers on alternative methods in specific circumstances.  
However, although a few specific areas have established validated non-animal test methods (for example, skin irritation for dermal products), there are many areas for which alternative testing methods do not exist yet or have not yet been validated. Because the body is a highly complex, biological living system that is difficult to replicate in a testing environment, alternative testing methods cannot always predict side effects and safety concerns. Scientists must do more research and validation on alternative testing methods before they can be routinely and more broadly used. 
FDA scientists are working together to facilitate the development of alternatives to animal testing and build confidence in reliability of alternative methods. The FDA is strongly committed to reducing the use of animal testing, replacing animal testing with alternative methods when they are available, and refining animal testing so that the maximum amount of scientific information can be humanely collected with the minimum number of animals. These priorities – replace, reduce, and refine – are known as the “3Rs.” These priorities guide the FDA in our commitment to alternatives to animal testing. 
Bottom Line: Scientists at the FDA are working together, and with industry partners, to advance the development and adoption of alternatives to animal testing. Currently, for most products under development, there are no testing methods that can entirely replace animal testing. Researchers and scientists in many areas must do a lot more research and development to create valid alternative methods. 

Fact: Federal laws regulate the treatment of test or research animals. 

More Information: Scientists who conduct research with animals must follow the applicable laws, regulations and standards regarding the treatment and care of animals used in research and testing. These include:
In all cases where animal studies are used, the FDA advocates that research and testing results in the maximum amount of useful scientific information from the minimum number of animals while using the most humane and scientifically valid methods available.
The FDA supports the transfer, adoption, or retirement of research or testing animals, when possible. However, the FDA does not own animals used by other organizations, such as product developers and manufacturers, in animal testing and does not control their placement after study.
Bottom Line: The FDA shares any concerns about test or research animal welfare with the federal agencies and offices who regulate and enforce standards of animal treatment and care, including the USDA and OLAW.


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