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FDA Scientist Says She Was Reprimanded For Warning

Posted Jul 10 2010 1:05pm

Rosemary Johann-Liang thought she’d be able to leave her job Friday at the Food and Drug Administration, where she worked for 6½ years, without much fanfare.
“I was trying to leave peacefully,” she said in a telephone interview on the eve of her last day as deputy director of the Division of Drug Risk Evaluation, part of the Office of Surveillance and Epidemiology (formerly the Office of Drug Safety). “I had nice parties last week.”

But then the popular diabetes drug Avandia began making headlines because a prestigious medical journal aired concerns about its safety. Johann-Liang found herself in the media spotlight.

The reason: She took her staff’s advice and recommended in February 2006 that Avandia get a “black box” warning about congestive heart failure. For doing so, FDA staffers told Senate Finance Committee investigators, Johann-Liang was verbally reprimanded and told to talk to her director before making any major recommendations related to drug safety.

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