DTC whodunit: Rozerem ad gets rebuke

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A sleep drug marketing mystery unfolded as Takeda and its agencies denied producing a TV ad that drew an FDA notice of violation.

FDA asked Takeda to stop running a 10-second Rozerem spot, which it said does not qualify as a reminder ad. The ad, advising viewers “Rozerem would like to remind you that it’s back to school time,” aired about four times in September on MSNBC.

“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,” Matt Kuhn, Takeda director of PR, told MM&M. “We will continue to investigate how this happened and will include those findings in our response to the FDA.”

The ad cited was not part of the “Your dreams miss you” campaign, whose agencies, Cramer-Krasselt and AbelsonTaylor, told MM&M they did not create it. MSNBC could not be reached.

A source familiar with the situation speculated that the generic-looking spot may have been produced and aired by the cable network, with the brand name plugged in mistakenly as part of a larger ad placement deal. Calls to MSNBC were not returned.

FDA’s Division of Drug Marketing, Advertising and Communication interpreted the ad as being aimed at children, and noted that Rozerem is not indicated for pediatric use. DDMAC also cited Takeda for not submitting the ad to the agency, as required when ads are disseminated.

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