Kelsey%201 - By GARDINER HARRIS Published...

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The Public’s Quiet Savior From Harmful Medicines By GARDINER HARRIS Published: September 13, 2010 CHEVY CHASE, Md. — She is unlikely to be mentioned at any 50th-birthday parties this year, but she is the  reason many of those celebrations will take place. Enlarge This Image Brendan Smialowski for The New York Times SHIELD Dr. Frances Oldham Kelsey will be honored by the F.D.A. Enlarge This Image The White House RECOGNITION President Kennedy gave Dr. Kelsey the Distinguished Civilian Service Medal in August 1962 for saving newborns from the perils of the drug thalidomide. Dr. Frances Oldham Kelsey is 96 now, nearly deaf and barely mobile, as modest as her faded house in this  Washington suburb. And though her story is nearly forgotten, she was once America’s most admired civil  servant — celebrated for her dual role in saving thousands of newborns from the perils of the drug  thalidomide and in serving as  midwife  to modern pharmaceutical regulation. On Wednesday, Dr.  Margaret Hamburg , commissioner of the  Food and Drug Administration , will honor Dr.  Kelsey with the first Kelsey award. It will be given to a F.D.A. staff member annually. The award will come 50  years after Dr. Kelsey, then a new medical officer at the agency, first sat down to consider an application from  the William S. Merrell Company of Cincinnati to sell a  sedative  named Kevadon, which was widely prescribed  in Europe for morning sickness  in  pregnancy .
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As it turned out, the drug (better known by its generic name, thalidomide) would cause thousands of children  in Europe to be born limbless or with flipperlike arms and legs. With her probing analysis of Merrell’s  application and her insistence on scientific rigor, Dr. Kelsey ensured that the effects in the United States were  far more limited. The thalidomide disaster led Congress to pass legislation giving the F.D.A. authority to demand that drug 
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Kelsey%201 - By GARDINER HARRIS Published...

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