What happens when Big Pharma endangers kiddies? They get a strongly worded letter, of course

Takeda Pharmaceuticals North American, Inc. has been cited by the FDA for airing unapproved reminder ads for its sleep aid medication Rozerem. Here’s an excerpt from the citation letter, courtesy of PharmaLive:

While reminder ads are exempt from the requirement to disclose information relating to risks and effectiveness, for the reasons set forth below, we have determined that your TV ad is not an appropriate reminder ad. As such, the failure of the TV ad to disclose the drug’s indication, the failure to include information relating to the major side effects, and the failure to make adequate provision for dissemination of the FDA-approved labeling … thus misbrands Rozerem …

Although the TV ad does not state the drug product’s indication or recommended dose, the statements and images suggest that Rozerem is indicated for children. Specifically, the TV ad includes the following statements and corresponding visuals: “Rozerem would like to remind you that it’s back to school season.” (visuals include chalk board, school books, school bus, laptops, school-aged children with backpacks) … The combination of these statements (“Back to School”) and images of school-aged children and school-related objects suggest that Rozerem is indicated for and can be safely used in the pediatric population…

The presentation in the TV ad is especially concerning given that the PI for Rozerem includes the following Precaution regarding pediatric use: “Safety and effectiveness of ROZEREM in pediatric patients have not been established. Further study is needed prior to determining that this product may be used safely in pre-pubescent and pubescent patients.”…

Takeda’s explanation for the ad targeting kiddies? According to The Pharma Blogosphere Blog, the company stated:

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.

That’s accountability for you.

And Takeda’s punishment? A strongly worded letter.

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