 Frances Kathleen Oldham Kelsey , CM ( July 24 , 1914 – August 7 , 2015 ) was a Canadian pharmacologist and physician . As a reviewer for the U.S. Food and Drug Administration ( FDA ) , she refused to authorize thalidomide for market because she had concerns about the drug 's safety . Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects . Kelsey 's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals . Kelsey was the second woman to be awarded the President 's Award for Distinguished Federal Civilian Service by President John F. Kennedy . 
