As John Mack at PharmaMarketing blog points out, this raises an interesting question about whether Pfizer skirted FDA regs. Here's why: the logo and sponsorship at the front end of the NFL update smells like a reminder ad, which mentions the Chantix name but not the indication (some may argue otherwise, but flashing a product logo is, after all, designed to remind you of something). And the ad for the Time to Quit site mentioned the health problem but not the product itelf, which resembles a Help-Seeking ad - an ad that focuses on a disease, although viewers weren't directed to talk to their docs, which is how the FDA defines this kind of ad.
Separately, neither of these types of ads must contain risk info. But if such ads are combined, they may well be required to include risk info. Why? This is from the FDA draft guidance on Help-Seeking ads...
"Together, however, these two advertisements communicate information about a treatable disease or health condition and the name of a product approved for treatment of a disease or health condition, and effectively constitute an advertisement that communicates a product's indication and efficacy for a certain medical condition without providing risk and other information. If a disease awareness or help-seeking piece and a reminder advertisement are presented in a manner that causes their messages to be linked together by the audience, the failure of the combined communication to include the risk and other information required under the act and FDA regulations would cause the advertised product to be misbranded."
Now, Pfizer may argue that flashing a logo doesn't constitute a reminder ad and its spot for its Time to Quit site isn't really a Help-Seeking ad, because no one was told to talk to a doc. But as Mack speculates, this sort of one-two punch smacks of a violation, because less than a minute separated the two messages. We agree - it would appear Pfizer emulated a savvy football coach and got away with an end run. And we think this presentation warrants a closer look. But what do you think?
Does this ad combo violate FDA regs?
- Yes (71%, 49 Votes)
- No (29%, 20 Votes)
Total Voters: 69
Hat tip to PharmaMarketing