In 1960 Dr. Frances Oldham Kelsey was the new medical officer at the Food and Drug Administration when she was assigned the review of a new drug application for thalidomide. The drug was already being sold to pregnant women in Europe and other countries as an anti-nausea drug to treat morning sickness. But Dr. Kelsey refused to approve the application without adequate evidence that the drug was safe. By late 1961 scientists had discovered that thalidomide was causing crippling birth defects in thousands of babies.
In a front page article in the Washington Post published in 1962, Dr. Kelsey was described as a "heroine" whose "skepticism and stubbornness ... prevented what could have been an appalling American tragedy." In the aftermath of the thalidomide case, President John F. Kennedy gave her the Distinguished Civilian Service Medal and she helped strengthen the FDA’s rules for clinical trials.
The FDA now honors one of its employees every year with the Dr. Frances O. Kelsey Drug Safety Excellence Award. Before working for the FDA, Dr. Kelsey taught at the University of South Dakota medical school and served as a fill-in doctor at practices around the state. Although her South Dakota years are often overlooked by writers, her daughter says they were very important.
Dr. Frances Kelsey died on August 7 at the age of 101. FDA historian John Swann joined Dakota Midday and discussed her legacy.
You can read Dr. Kelsey's autobiographical remembrances here.
