Takeda and its agencies deny responsibility for an ad that drew an FDA untitled letter.
The FDA asked Takeda to stop running a 10-second televised Rozerem TV spot, which it said does not qualify as a reminder ad. The ad used the tagline “back to school” and aired about four times last September on cable network MSNBC.
“Takeda has received the letter and we are in the process of preparing our response to the FDA,” Matt Kuhn, Takeda director of PR, told MM&M. “To date, 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. We will continue to investigate how this happened and will include those findings in our response to the FDA.”
The reminder ad cited by the FDA was not part of the campaign, “Your dreams miss you.” That campaign's agencies, Cramer-Krasselt and AbelsonTaylor, told MM&M they did not create the back-to-school ad. MSNBC could not be reached.
A source familiar with the situation suggested that the generic-looking spot may have been mistakenly aired by the cable network as part of a larger ad placement deal. But that could not be confirmed, as calls to MSNBC were not returned. As of Monday, Takeda did not have a final answer on what happened.
“This has been a puzzlement to a lot of us,” said Dale Taylor, president of AbelsonTaylor. “Where it has come from and where it was produced is a mystery to me.”
In the untitled letter posted on the Web last Thursday, the FDA’s promotional division said Takeda violates a stipulation that reminder ads may not contain “representation or suggestion relating to the advertised drug product.”
A voiceover in the ad states, “Rozerem would like to remind you that it’s back to school season,” as images flash by of schoolchildren, notebooks, a classroom and a yellow school bus.
Such statements and images suggest that Rozerem is indicated for children, according to the warning letter. Not only does Rozerem’s label not include a pediatric indication; but the package insert contains a precaution concerning effects on reproductive hormones in adults, such as decreased testosterone levels and increased prolactin levels. “It is not known what effect chronic or even chronic intermittent use of Rozerem may have on the reproductive axis in developing humans,” the PI states.
Because the ad is not a reminder ad, it must present the indication and information relating to the major side effects and other labeling information. FDA's Division of Drug Marketing, Advertising and Communication (DDMAC) asked the company to stop running the ad or similar promotions.
DDMAC also cited Takeda for not submitting the ad to the agency, which firms are required to do at the time ads are disseminated but not prior to airing.