Animal Welfare, Testing and Research of FDA-Regulated Products

Medical and veterinary products save lives every day. FDA-regulated products such as blood pressure medicine, chemotherapy and MRI machines help people and animals live longer and healthier.

The U.S. Food and Drug Administration 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 they almost always include other types of tests.

Here are some facts about animal testing and their alternatives.

Using Scientifically Valid Alternatives to Animal Testing

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

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. They include:

• Laboratory tests in a petri dish or test tube, which may include tests with human or animal cells and tissues (in-vitro testing).
• Computer modeling (in-silico testing).
• Animal testing (in-vivo testing).

Testing a product with people is called clinical testing, also known as clinical investigation or clinical trials. 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 determine which types of tests they will conduct, in consultation with the FDA, and can use alternative methods to animal testing. They often conduct animal testing at some stage of the product development process because scientifically valid alternatives to animal testing are not available yet.

FDA Supports Developing Alternatives to Animal Testing

The FDA encourages industry efforts to develop and use alternative methods to test the safety of FDA-regulated products. 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.

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 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 the procedures can be routinely and more broadly used.

FDA scientists are working together to help in 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.
• 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,” and they guide the FDA in our commitment to alternatives to animal testing.

Scientists at the FDA are working together, and with industry partners, to advance the development and adoption of alternatives to animal testing. For most products under development, there currently aren’t testing methods that can replace animal testing entirely. Researchers and scientists in many areas must do a lot more studies and development to create valid alternative methods.

Federal Laws on the Treatment of Test or Research Animals

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:

• The Animal Welfare Act and Animal Welfare Act Regulations from the U.S. Department of Agriculture (USDA).
• The Public Health Service Policy of Humane Care and Use of Laboratory Animals from the National Institutes of Health Office of Laboratory Animal Welfare (OLAW).
• The Guide for the Care and Use of Laboratory Animals from the National Research Council.

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. But 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.

The FDA shares any concerns about test or research animal welfare with the federal agencies and offices that regulate and enforce standards of animal treatment and care, including the USDA and OLAW.