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Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat

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The Holiday Inn in Bethesda, Maryland, is an unassuming stucco building tucked sideways off a slow commercial street, across from a Pizza Hut, a gas station, and a mini-mart. You enter from the side driveway and climb up a wide, curving staircase to reach the Versailles II ballroom on the second floor.

On a sunny February morning in 2004, as week-old snow lingered in piles at the edge of the sidewalk, it was standing room only in that ballroom. Some three hundred people had come—parents, grandparents, siblings, and friends, bearing posters and white satin ribbons—to talk to the United States Food and Drug Administration about the medicine that had killed someone they loved.

The long room was decorated in shades of beige and blue, with textured beige wallpaper, beige-and-brown carpeting in a fleur-de-lis motif, and a turquoise ceiling studded with 16 crystal chandeliers. At one end, three tables had been arranged in a large “U” for the two panels of 36 outside experts who had been summoned to advise the FDA, along with a few agency staffers. Facing them were rows of burgundy-and-purple brocade chairs, a battery of TV cameras, and a microphone for the audience.

They came from Rhode Island and California, from Texas and Colorado, Arizona and Pennsylvania. Most of them were middle-aged, the men in business suits, the women in nice slacks. One mother quoted the Book of Revelations; another wore a button supporting Democratic Senator John Edwards for president. A 10-year-old girl read an Archie comic book, while a boy of about six played with his GameBoy. In the hall outside the ballroom, one blonde woman asked another, “Was your daughter suicidal?”
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