Yesterday, we wrote how Pfizer may have made an end run around FDA regs with a pair of TV ads this past Sunday night. The first one was a quick flash of the Chantix logo during an NFL update, which was also sponsored by Pfizer. After the segment on football scores ended, a regular ad appeared for a Pfizer site devoted to
quitting smoking, which links you to the official
Chantix site.
The issue: the first ad smelled like a reminder ad. After all, a logo is there to remind you of something, yes? And the second ad, while not suggesting anyone visit a doc, was about as close as one get to running a so-called 'help seeking' ad without actually doing so. By themselves, neither require any product risk info. But taken together, it would appear risk info is required and the ads, therefore, may violate FDA regs.
As an FDA guidance notes: "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.â€
So we asked what you thought - did Pfizer violate FDA regs? Most of you believe the drugmaker did.
Yes - 49 votes, or 71 percent; No - 20 votes, or 29 percent.
[Again, our thanks to PharmaMarketing blog for 'reminding' us of the ads].
3 Comments
So, Pfizer violated FDA guidelines. Who's going tell the FDA?
Bah, Pfizer owns stock in the FDA - expect a slap on the wrist.
John Mack, as a reminder, just because a poll of nonexperts says that Pfizer violated FDA regulations, doesn't make it so. Giving you the benefit of the doubt as an industry expert, your initial analysis suggested that this doesn't violate FDA guidelines, except, perhaps in spirit.