Animals Behind Top Drugs

Are you taking a prescription medicine?

Because animal research and testing were behind almost every prescription medicine available today.

The U.S. Food and Drug Administration (FDA) requires animal testing to ensure the safety of many drugs and devices.

1962 amendments to the Federal Food, Drug and Cosmetic Act paved the way for the modern drug approval process, which involves preclinical tests on animals. The FDA can mandate drug sponsors or manufacturers to provide reports on “preclinical tests (including tests on animals) … adequate to justify the proposed clinical testing” or “primary data tabulations from animal or human studies,” according to federal law.

Click here to view regulations for submitting an Investigational New Drug Application with the FDA. “The investigator brochure is required to include information about the drug substance and formulation, pharmacological and toxicological effects of the drug in animals (and in humans, if known),” a 2010 FDA final rule says.

Animal testing is necessary for understanding the safety and proper dosages of new medicines and treatments. If researchers find that a drug is safe and effective through animal testing, they can begin testing it in small groups of people and then larger groups of people. Human and animal testing is required by law before a drug can be approved. However, for safety reasons the FDA requires animal testing before there can be clinical drug trials in people. It would be dangerous and extremely unethical for scientists to test drugs on humans before making sure they are safe. So, animal research and testing is an important first step. Learn more about which lab animals have contributed to the most common prescription drugs in the chart below.

What about the medications that vets prescribe for pets? Indeed, they were developed and tested with animals, too! Learn more about how dogs and cats have benefited from drugs used to treat anxiety, arthritis, heartworm, and more.