A Brief History
On August 7, 1962, a reviewer from the U.S. Food and Drug Administration, Dr. Frances Oldham Kelsey, was recognized by President John F. Kennedy with the President’s Award for Distinguished Federal Civilian Service.
Digging Deeper
Kelsey had previously denied the use of the drug, Thalidomide, for use in the US after it had been used in West Germany since 1957 for a wide range of symptoms, including morning sickness in pregnant women. Dissatisfied with the safety research and record to date, Kelsey turned down the drug for the US, ultimately saving untold hundreds or even thousands of babies from being born with horrific birth defects.
Hired by the FDA in 1960, Kelsey made her fateful decision a month later, before Thalidomide was withdrawn from the German market in 1961 when the side effects were found out. This Canadian born physician and pharmacologist proves government employees can make a major difference by doing their job well.
Note: Thalidomide has been approved for cancer treatment in the US since 1998, obviously not for pregnant women. In the 1930s, before getting her PhD and MD, Kelsey was a pioneer in researching drugs that could cross the placental barrier. Kelsey was only the second woman to be given the President’s Award.
Question for students (and subscribers) to ponder: Do you know a civil servant worthy of note?
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Historical Evidence
For more information, please see…
Gaw, Alan. Born in Scandal: Frances Oldham Kelsey & the Development of Pharmaceutical Regulation. SA Press, 2013.
Warsh, Cheryl K. Frances Oldham Kelsey, the FDA, and the Battle against Thalidomide. Oxford University Press, 2024.
