Takeda Borrows Cephalon's Excuse for FDA Warning Letter

A bizarre and almost unbelievable story in the WSJ today: Takeda aired a 10 second ad for Rozerem with the theme, "Rozerem would like to remind you that it's back-to-school season." It included images of a school bus, a blackboard, a laptop, and kids  with backpacks.

Naturally, the FDA slapped the company with a warning letter because of the teensy technicality that Rozerem is not approved for children. (And even if it was, what kind of person would give their kid a sleeping pill?) Most interesting is Takeda's explanation: "Our preliminary review of the situation indicates that no one internal to Takeda was involved in the approval, release or broadcast of the advertisement in question," according to an email Takeda pr chief Matt Kuhn sent me this morning.

This, of course, is extremely similar to Cephalon's explanation of how an off-label letter was distributed for its Provigil sleep drug at a conference last year. (Read that here.) Is this the start of a new trend in dealing with the FDA: It wasn't us, someone else did it?  It's the Big Pharma version of 'the dog ate my homework'!

Regular Brandweek readers will know that this is the latest in a series of troubles for Takeda and Rozerem, including great marketing that doesn't seem to be working, key marketing execs who bailed during the launch, sales and marketing costs outstripping revenue, and an initial strategy that ignored the drug's main advantage--its superior safety indication. (Recently, new Rozerem ads have leaned more heavily on the non-addictive angle).