Frances Kelsey and

Frances Kelsey, Memorandum of Meeting between Frances Kelsey and Mr. Marshalk, 13 August 1962. FDA Files, AF1-542, Accession 72A 2957. 

The drug was taken off the market in 1961 and the increased incidence of these rare birth defects disappeared at the predicted time thereafter. Very few cases were reported in the United States, where full-scale entry into the marketplace was delayed because of some careful work by Dr. Frances Kelsey of the FDA. Perhaps 8000-10 000 cases were reported worldwide. The offspring of women taking the drug during the sixth and seventh weeks of pregnancy were found... 

The U.S.-based pharmaceutical company William S. Merrell, Inc., licensed thalidomide from its German manufacturer, Chemie Griinenthal, in 1958. After carrying out laboratory, animal, and initial human tests, the company submitted an application to the FDA for marketing authorization. Frances Kelsey, the medical officer assigned to review the application, found deficiencies in the animal studies and criticized the company s testing methods.20 She then requested additional toxicity tests, putting the application on hold. 

Figure 1. President John Kennedy signing the 1962 Kefauver-Harris Amendments to the Food and Drug Act into law. Fie is handing the pen to Estes Kefauver Frances Kelsey is second from the left. (FDA Flistory Office)...

Dr Frances Kelsey had the thalidomide application on her desk. She was busy and had simply not got around to it. Then from Europe she heard about a question of peripheral neuropathy, and possibly thyrotoxicity at that point she made an active decision to hold up the approval. It was an Australian dermatologist who identified drug-induced phocomelia, and the rest is well known. Only nine cases of phocomelia were reported in the United States, from an exposure of about 4000 women of childbearing potential, most of whom were pregnant. Kelsey received a medal from President Kennedy. 

There is much more to the story of thalidomide, and it is not a nice tale at aU. If you would like to read more about the extraordinarily shabby science that went into the testing of this drug, and the even shabbier sociology, see Roald Hoffmann, Tfie Same and Not the Same, Chapter 20 (Columbia University Press, 1995). Here you will also encounter Dr. Frances Kelsey, the FDA physician who played a major role in preventing thalidomide from being licensed in the United States. She is a real hero of our time. 

U.S. law at the time allowed dmgs that had not yet been approved by the FDA to be distributed to physicians for experimental use. Nevertheless, only 17 thalidomide babies are known to have been bom in the United States. If not for the diligence and dedication of Dr. Frances Kelsey, there would almost certainly have been thousands more. In recognition of her incalculable service to the people of the United States, Dr. Kelsey was given the President s Award for Distinguished Federal Civilian Service, the... 

Bren, Linda. Frances Oldham Kelsey FDA Medical Reviewer Leaves Her Mark on History. FDA Consumer 35, no. 2 (March/April 2001) 24-29. This article tells the story behind Kelsey s actions to block the approval of thalidomide and prevent the epidemic of birth defects that occurred in Europe from playing out in the United States. When working for the FDA, she demanded better studies of the drug s long-term safety, after which evidence of harm from Europe emerged and justified her careful approach. 

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