The thalidomide disaster led Congress to pass legislation giving the F.D.A. authority to demand that drug makers prove their products safe and effective. Moreover, Dr. Kelsey helped write the rules that now govern nearly every clinical trial in the industrialized world, and was the first official to oversee them.
“She had a huge effect on the science that we all take for granted today,” said Daniel Carpenter, a professor of government at Harvard and the author of “Reputation and Power” (Princeton, 2010), a definitive history of the F.D.A. . .
Dr. Kelsey’s role in the saga would have remained little known if not for a front-page article in The Washington Post — which, in turn, led to legislation giving the F.D.A. far more power over the drug industry. President John F. Kennedy gave Dr. Kelsey the Distinguished Civilian Service Medal, and a picture of her accepting the award wearing a black dress, holding a white purse and looking demure but competent became the iconic image of the agency.
“It was up in Maine, where he had that summer home,” Dr. Kelsey said. “He was handsome and very pleasant.”
With the F.D.A. given far more power, Dr. Kelsey set about with others at the agency to write rules for medical testing that created three distinct phases for human trials and strengthened rules for human protections and conflicts of interest. These rules have since been adopted worldwide. As the historian Dr. Carpenter put it:
“She and the F.D.A. had a huge role in determining the terms and sequence of what is now modern clinical science.”
http://www.nytimes.com/2010/09/14/health/14kelsey.html?hpw
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