Reports are out that a deputy director of the Division of Drug Risk Evaluation, part of the Office of Surveillance and Epidemiology (formerly the Office of Drug Safety) was reprimanded for recommending that the popular diabetes drug Avandia receive a ?black Box? warning after taking her staffs advice.
Rosemary Johann-Liang was on the verge of leaving her job with the FDA after 6 1/2 years with the agency. The USA Today reports that FDA spokeswoman Susan Cruzan said Friday that the agency is looking into whether Johann-Liang was reprimanded for her opinion. "We don't know if that's actually the case," Cruzan said.
Johann-Liang told USA Today, "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.?
She says much of the problem lies in the fact that the Office of Surveillance and Epidemiology only has the power to recommend to take action against unsafe drugs. Many times the same official that originally approved the drug is the same one who decides whether to take action.
According to USA Today, ?In her two years in the Office of Surveillance and Epidemiology, Johann-Liang says, "I worked really 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."Johann-Liang speaks of a convoluted system in which the FDA requires a higher level of proof of risk than of effectiveness.
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