In 1960, at the beginning of her pharmaceutical career, Dr. Frances Kelsey took a courageous stand against granting FDA approval to the drug thalidomide. In spite of pressure from manufacturers, her refusal to permit distribution in the United States was due to a lack of evidence supporting the drug’s safety. Kelsey’s protest prevented an international health crisis from reaching the United States, serving as a turning point in transforming pharmaceutical testing regulations domestically and abroad.
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One Response
This is a great article. However, it makes it seem as if we in the US never administered Thalidomide to pregnant women. We did, because I know of a survivor who has shortened stature, shortened arms and legs. My own mother was supposed to be given Thalidomide due to multiple miscarriages but never took it. I would like to see a notification that this was given in the US and there physicians who gave it to mothers in the United States. This tragedy was not completed avoided and should be stated as such.