August 7, 2015
The drug thalidomide was prescribed to pregnant women during the late 1950s, and resulted in the births of over ten thousand babies with severe birth defects worldwide, and in the actual loss of several thousand additional pregnancies. However, the tragedy was averted in the United States, as the FDA did not approve thalidomide for use by pregnant women. This was primarily due to Dr. Kelsey's concerns about a lack of any studies demonstrating the effects of thalidomide in pregnant animals. It was this tragedy that demonstrated the importance of animal research in drug development and lead to significant changes in the FDA requirements for new drugs, especially those intended to be marketed to pregnant women.
Read more about why this is an animal research issue.