Thursday, May 06, 2010

Will FDA Cite this Vyvanse Web Image as Off-Label Promotion?

If an image is worth a thousand words, then this image found on the Vyvanse Web site home page is shouting off-label promotion.

Is it a coincidence that this image, showing a woman ("Fran") with a measuring tape and a dress, evokes weight loss, which is one of the common side effects of Vyvanse and similar stimulant dextroamphetamines?  (Vyvanse is a "prodrug"; it gets converted to stimulant dextroamphetamine in the body). Thanks to "Chad" who pointed this out to me via the "Contact Us" link above.

Other drugs have been promoted off-label for weight loss. Just yesterday I reported that Johnson & Johnson was fined $81.5 million for misbranding and illegally marketing Topamax for weight loss, among other things (see "Trouble in the House that McNeil Built: Why Drug Company Silos are Useful").

Compared to the Topamax off-label case, the Vyvanse off-label imagery is pretty subtle and perhaps only people like me (and "Chad") would even think it was more than a coincidence. Images in direct-to-consumer (DTC) ads, however, are carefully chosen by pharma marketers and the FDA does pay close attention to them as part of the overall message. An example is the shrinking planet Avodart ad that received an FDA letter because the image showed too much shrinkage (see "FDA Warns GSK About Enlarged Avodart Ad Imagery"). Other critics have even pointed out things like the speed of flapping bee's wings in some DTC ads (see "Ruth Day and the Bees Repeat Performance at House DTC Hearing").

These days, the FDA is paying more attention to subtleties in Rx drug promotions. For example, FDA recently sent Novartis warning letters about two unbranded Web sites that it said illegally promoted Gleevec even though the brand name was not mentioned on the sites (see "FDA Warns Novartis Over Gleevec Internet Sites").

Maybe the FDA reads this blog and will take a look at the Vyvanse Web site. If it decides to send Shire a letter, it may not happen for several months, by which time "Fran" may have been replaced by "Frank," a trucker having a late night meal at a truck stop. Pretty stimulating image, eh?


  1. Hmmm...I'd have to say this is a bit too far of a stretch for me. If FDA does something based on this image, there are a lot of websites in trouble out there. I think you can look at any image and interpret it however you wanted if the goal was to look for violations. This would be a disturbing precedent if it happens. However, I've learned not to be surprised anymore.

    Dose of Digital

  2. I have to agree with Jonathan. That's a big stretch for me too.

    I'm very familiar with ADHD, and a job in retail would be nearly impossible for someone with uncontrolled ADHD symptoms. I think Shire got it right with this ad. They really hit on some of the problems that adults with ADHD face.

  3. Well, Fran could have been depicted as a cashier at a Wall Marts and it would made the same point you are talking about. The tape measure in this image says more than just "retail."

    But, I too think it is unlikely for FDA to cite this. If, however, Fran is replaced by an equally suggestive new person (eg, "Frank" as I imagined him), then it would be less of a stretch.

  4. Anonymous12:24 PM

    I agree it is a stretch.

    I also understood the image to be of a clothing designer, not a salesperson. She was able to design, sew, and sell the dress.

    Think "Project Runway".

  5. If you don't read the ad copy b4 seeing the pic it def gives the impression that a big woman will be able buy a small dress.

  6. Anonymous11:55 AM

    Come on guys...

    Who shops for or sales clothes with a tape measure around their neck and a pin cushion attached to their wrist?

    This is clearly a designer with the common tools of her trade at the ready.

    It's a profession that requires a lot focus to be successful. Which is what this drug helps people do. Therefore, an appropriate profession to demonstrate the benefits of the drug.

    John, I strongly disagree with your Wal-Mart cashier comment. A photo of a cashier at Wal-Mart would emote something along the lines of — you can forget your dreams of being a successful clothing designer, face it you have ADHD you're going to be nothing more than a cashier at Wal-Mart. (In which case, you can't afford the drug.)

    If you've ever tried to sell creative work to pharma companies, you'd know they don't always "carefully" choose their images. A lot of times it comes down to money. Instead of creating original artwork, they force their agencies to use cheap stock photography. Which from the looks of this ad, is case here.

    My guess is that the art director would have rather set up an original photo with Fran thriving in her work environment. i.e. Happily working in her design studio, maybe looking at some swatch fabrics, etc. with a row of dresses with sold tags along the wall behind her.

    I really doubt they were trying to subtly hint an additional indication. The art director most likely had to find the best photo he/she could to represent the concept and the audience for little to no money and in little to no time. That's the reality of creating pharma advertising.

    If you don't believe me, try finding a stock photo that represents an adult female, 25 to 35 years of age having a successful career in a field that represents the qualities common in ADHD — creative and entrepreneurial. Oh yea, you'll also need to find one with a same requirements for a male. And let's not forget the children. Make sure they have the same look and feel. And one more thing, I'd like to see them in my inbox first thing tomorrow.

    That's what "careful" really looks like.

    So in my mind, what you've really hit on is why pharma companies should be more "careful" when creating advertising. In other words, trying to cut corners to save a few bucks can lead to unwanted side effects. i.e. people misinterpreting what you're brand/drug is all about and possibly even getting slapped with heavy multi-million dollar fines.

    A $6000-$15,000 photo shoot is a heck of a lot cheaper than $81.5 million fine. Yes?

    I seriously doubt the FDA will even look twice at this ad. But if they do, it gives agencies a good reason to push back on when brand managers insist on using cheap creative options.

    Thank you.

  7. Anonymous1:45 PM

    I think this is a stretch as well... furthermore I happen to be a designer who in recent months was diagnosed with adult ADD. I take Vyvanse daily and cannot tell you how much of a change it's made in my life. It was like being on a merry-go-round my entire life and I couldn't get off, after I started taking the medication the merry-go-round slowed and stopped. I am pointing this out because as a result of being able to focus at work I have been able to better define goals and work on projects. My work has indeed improved. I seem to be able to concentrate and organize better which has in turn made me a better designer. So for me this is an ad that relates to me and has nothing to do with a size 4 dress, she is a designer in the photo not a supermodel. I haven't lost a great deal of weight and eat just fine. They need to get over the advertisement... seriously.


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