FDA scientist says she was reprimanded for warning of Avandia risks
Rosemary Johann-Liang took her staff's advice and recommended in February 2006 that Avandia get a "black box" warning about congestive heart failure. FDA staffers told the Senate Finance Committee investigators that Johann-Liang was verbally reprimanded and told to talk to her director before making any major recommendations related to drug safety. Johann-Liang says, "I really advocate for drug safety, and a lot of times the agency doesn't want to hear that there are problems. I think, in general, there is a culture of 'The drug is always innocent.' " Part of the problem, she says, is that the Office of Surveillance and Epidemiology can only recommend how to manage risks linked to drugs. The Office of New Drugs, the same office that approves drugs, is the one that decides whether to take action. With Avandia, Johann-Liang says, "when we recommended this black box, they said they wanted to look at it further." But the Office of New Drugs never got around to it, she says, because they were pressed to meet deadlines for acting on new drug applications. In her two years in the Office of Surveillance and Epidemiology she worked hard to institute systematic safety meetings with the Office of New Drugs. She says Congress needs to increase staffing in the surveillance and epidemiology office and give it the authority "to take action in a timely manner."
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