Dr. Frances Kelsey, who lived to 101, would have turned 102 this year on August 7th.
She was the FDA pharmacologist and physician who kept the sedative Thalidomide off the U.S. market in 1960 and 1961, despite pressure from the drug’s manufacturer.
Suspicious about the “glowing” claims made by the manufacturer, Dr. Kelsey was concerned that Thalidomide, which was being used in Europe to alleviate morning sickness, could have unknown side effects.
The link between Thalidomide and severe birth defects (such as phocomelia) emerged in late 1961. Thousands of European babies ended up with Thalidomide-related birth defects. Many of these babies did not survive infancy.
In July of 1962, Washington Post reporter Morton Mintz broke the Thalidomide story with an article entitled, “‘Heroine’ of FDA Keeps Bad Drug Off Market.” It opened,
This is the story of how the skepticism and stubbornness of a Government physician prevented what could have been an appalling American tragedy, the birth of hundreds or indeed thousands of armless and legless children.
The next month, Dr. Kelsey received the President’s Award for Distinguished Federal Civilian Service from John F. Kennedy.
Later the same year, amendments to the Federal Food, Drug, and Cosmetic Act that “required drug manufacturers to prove scientifically that a medication was not only safe, but effective” was signed into law.
Dr. Frances Kelsey’s first name comes from the Late Latin name Franciscus, meaning “Frankish” or “Frenchman.” Her surname, originally a place name, is made up of two parts: the Old English byname Cenel (from cene, meaning “bold” or “valiant”) and the Old English word eg, meaning “island.” Frances was trendiest in the 1910s, while Kelsey was at peak popularity in the early 1990s.
Sources: Changing the Face of Medicine | Dr. Frances Kathleen Oldham Kelsey, “Autobiographical Reflections” by Frances Oldham Kelsey, Ph.D., M.D. (PDF), Kefauver-Harris Amendments Revolutionized Drug Development, Kelsey – Behind the Name