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FailureToCommunicate

(14,607 posts)
1. "and (only) several cases in the US" Thanks must go again to Dr Francis Kelsey
Wed Jul 18, 2012, 09:35 AM
Jul 2012

Without her resistance to the big drug companies, there would have been tens of thousands of thalidomide babies in the US.



"Thalidomide was never approved by the FDA for use in the United States, and therein lies one of the FDA’s greatest success stories. In November of 1960, Dr. Francis Kelsey, the FDA official charged with overseeing thalidomide’s New Drug Application (NDA), was concerned that thalidomide might cause neuropathy, a nerve disease, in some users. She decided that the thalidomide NDA was incomplete and refused to approve it. This kept thalidomide tied up just long enough, since in 1961 the drug’s effect on newborn children became known. In 1962, President Kennedy presented Dr. Kelsey with a gold medal — the Distinguished Federal Civil Service Award — for her efforts."

http://leda.law.harvard.edu/leda/data/389/Scott_P_Glauberman.html

Thanks, Dipsydoodle, for the update.

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