The Devil in the Details - Chapter One
Dr. Frances Kelsey, the new medical reviewer at the U.S. Food and Drug Administration receives a dubious application for drug approval.
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Show Notes
In this first chapter of a new five-part season we meet Dr. Frances Oldham Kelsey, a physician and pharmacologist who joined the U.S. Food and Drug Administration as a medical reviewer in 1960. Before the year is out, Dr. Kelsey finds herself standing up to big pharma.
It’s September 1960 and a thick New Drug Application lands on Dr. Kelsey’s desk. The drug has already been on the market in Europe for three years and Dr. Kelsey’s supervisors expect her to rubber stamp the application. The drug is called Kevadon. Active ingredient: thalidomide. And to Frances Kelsey’s keen eye, something looks off.