FDA has sent Takeda a warning letter -- actually an "untitled" letter (merely a slap on the wrist) -- regarding it's Rozerem "reminder ads." Previously, I noted that by running these ads, Takeda violated its own pledge to abide by PhRMA's DTC Guidelines (see my original post, "Rozerem Reverts to Reminder TV Ads"). At that time, Takeda tried to claim that they were not reminder ads at all (see "Takeda: It Isn't a Reminder Ad --- Wha!!!").
Well, now Takeda is damned if the ads are reminder ads and also if they are not reminder ads, because according to the FDA, some of the ads are indeed "not reminder ads" and violate FDA regulations.
According to a Reuters story, the ads in question said said "Rozerem would like to remind you that it's back to school season" and included images of a chalk board, a school bus, books, laptops and school-aged children.
FDA suggested that Takeda itself go back to school and stop suggesting that Rozerem is approved for use in children: "The presentation is 'especially concerning' because Rozerem's prescribing information states that safety and effectiveness in pediatric patients have not been established, the FDA said."
See more on this at Pharmalot. The FDA warning letter is here. Thanks to Bruce Grant for the heads up!
Incompetent Reminder Ad at That!
Also, see Mario Cavallini's comment about what is what is not appropriate visuals to include in reminder ads.
Too bad this kind of nit-picking about reminder ads is not a moot point, which it would be if Takeda would only live up to its commitment to the PhRMA guidelines.
This just in...
The Dog Ate My Homework Excuse
According to BrandweekNRX: "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."
These Takeda people are some piece of work!
Not that I'm eager to defend Rozerem's misguided spot, but the DDMAC letter makes a curious shift, from “not an appropriate reminder ad” to “not a reminder ad.”
ReplyDelete21 CFR § 202.1(e)(2)(i) allows reminder ads to carry "graphic matter containing no representation or suggestion relating to the advertised drug product." Given Rozerem’s indication, that’s what the ad does. Now granted, it’s hard to figure what school images have to do with adult insomnia (unless it’s those pesky dreams about never-ending pop quizzes ...), but that just makes this an incompetent reminder ad, not a non-reminder ad.
I empathize with the DDMAC reviewers, but can we please not redefine the law just to make it fit the situation?
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