Blowing Smoke: Pfizer, Chantix Ads And FDA Regs

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smoke.jpgThere was an interesting moment during CBS’ ‘60 Minutes’ last night that had nothing to do with the news programming. First, there was a brief NFL update break that featured the logo for Chantix, the drug that is pitched to help you quit smoking. The announcer also noted the update was sponsored by Chantix. Then, after the rundown, there was an ad for, yes, Chantix. Well, sort of. The ad actually promoted a web site called MyTimeToQuit, which of course takes you to the Chantix site.

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 This is from the FDA draft guidance on Help-Seeking ads…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.”

chantix.jpgNow, 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

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Hat tip to PharmaMarketing

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  1. Ed,

    Thanks for running the survey.

    John

  2. I wonder how many times Lisa and her psycho crew voted…

  3. I want more surveys on psych meds - too sparse recently.

    Lisa, I have been working, but did I miss your credential posting?

  4. Todd,

    Surrre,.. after you provide yours. ohhh Thats right, I forgot, your a Jack of all Trades.

  5. do you want me to mail you my degrees, provide you my LinkedIn.com profile? Name it, but throw me a bone…. tell me honor roll in high school at least.

  6. Dear Bob,

    You can only vote once…….

  7. But then again if Lisa has a large psycho following……LOL….more vote’s…by the way are you diagnosing people on a blog, having never met them as psycho’s does that require a degree? Do you possess this degree?. And where can i get one? Guessing a box of Cracker Jack’s… And what would your prescription be other then battery operated device’s or someone of the opposite sex?

  8. Todd,

    Credential’s do mean alot, but does’nt make you smarter than anyone else, or better then anyone else I have found that Book educated people find it hard to think outside the box, they go day to day by what they have been taught, flip side of the coin are the other’s who have actually expierienced something, can we not learn thru expierience,can we not research and learn about what we have been thru, you may have degee’s hanging on your wall but some how i feel richer..

  9. “Book educated” what are you calling in from Arkansas??

    Things from Books

    How about: “Those who ignore history are doomed to repeat it..”

    Judgment comes from experience - and experience comes from bad judgment.

    I try to avoid experience if I can. Most experience is bad.
    E. L. Doctorow

    We learn from experience that people never learn anything from experience.
    George Bernard Shaw

    Mistakes are painful when they happen, but years later a collection of mistakes is what is called experience.
    Denis Waitley

    Sound familiar???

  10. Brian,

    Huhhhh …. Sound Familiar,..you are nuts!!!

    Id rather listen to Industry Spin. At least they make sense..

  11. mind your own business..you think the world revolves around you..It was Donna’s post I was refering too.. Think before you speak for a change

  12. Brian,

    Know Donna well!!! I’m sure she wont mind me chiming in.

  13. Todd,

    Just read your post, been very busy!.. My response to you is this…It is not what you know!.. But who you know.. Also saves on Postage..Hope this advice helps.

  14. Gosh, you mean patients who want to quit smoking would be sent to a website to get information on a great drug that could help them quit!! This is outrageous! Give me a break.. Pharma helping save more lives and people care more about why pharma is so bad?

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