Rozerem bitch slapped by the FDA
According to the yesterday's Wall Street Journal:
The agency posted on its Web site a "notice of violation letter" to the company detailing the problems with the advertisement.Matt Kuhn, spokesman for Takeda Pharmaceuticals North America, said the company isn't sure how the ad was released. "To date, a preliminary review of the situation is that no one internal to Takeda was involved in the approval to release" the ad, he said. Mr. Kuhn said the ad is no longer running and that the company will respond to the FDA.The ad stated, "Rozerem would like to remind you that it's back-to-school season," and included images of a school bus, computer and children walking with backpacks.The FDA said the images of children and school-related objects "suggest that Rozerem is indicated for and can be safely used in the pediatric population." A copy of the advertisement posted on the FDA's Web site suggested the ad ran on MSNBC in September.
"Nobody knows how the ad was released?" Uhhh..you really expect the FDA to believe that and if it is in fact true then Takeda has a hell of a lot more to worry about than an NOV, your business processes are in a serious need of a colonoscopy and someone needs to be held accountable. Frankly in today's business environment this is unacceptable and totally unacceptable for a highly regulated industry like prescription drugs. But hey ? Isn't this the company that uses a beaver and Abe Lincoln for its ads? Never mind...anyone thinks these ads are good obviously can't be someone we would expect to implement a process for its DTC.