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Extreme Marketing Makeover Needed: Warning Letter Issued for Shire YouTube Video

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Over the weekend, Pharmalot blogger Ed Silverman broke the story that FDA sent five (!) warning letters to pharma companies for "incomplete, false or misleading promotional materials for ADHD meds." Here’s Ed’s nice little recap: http://www.pharmalot.com/2008/09/fda-warns-five-drugmakers-over-adhd-ads/

But this is what really jumped out at me:

Among the ads cited was a YouTube video for Shire Pharmaceutical’s Adderall XR with Ty Pennington that was featured on “Extreme Makeover: Home Edition” ... A Shire spokesman said the video posting was made in error and that the video was removed last year.

Hold on there, buckaroos. The video was removed last year and they got a warning letter for it yesterday? I was intrigued and had to learn more ... was the video an official or rogue post? Was it the video itself, or user comments that pushed the limits? How did FDA still have it if it was removed last year?

For some light reading, the warning letter can be found here: http://www.fda.gov/cder/warn/2008/AdderallXR_Letter.pdf (thanks again Ed)

As far as I recall, this represents a couple of firsts. It’s the first time I remember hearing of a pharma receiving a Warning Letter for:

  1. A video on YouTube.
  2. A celebrity spokesperson endorsement

Looking at the video script quoted in the letter, I see the problem. Our spunky, fluffy-haired friend Ty called Aderall XR an "amazing transformation that literally changed my life" - and yes - he even calls it an Extreme Makeover. Um, I don’t think that’s an approved claim. It sounds like they didn’t include important safety information and didn’t submit the piece to DDMAC either, which makes me wonder if it was really was posted by someone other than Shire. They should know better.

I could kinda see how some unwitting soul from the video production company or agency got a hold of some edits off the cutting room floor, or a non-DDMAC savvy account exec decided to post it on YouTube "for fun" or to "see what would happen." (for the record, this would NOT be something Intouch would ever do! We specialize in pharma marketing, not warning letters.) It’s also possible that Shire posted it. Or that Shire suggested it get posted and then looked the other way. Sounds like whatever happened, it doesn’t really matter -- they’re getting their hands slapped anyway.

And - joy of all joys - the warning letter sniffed of government-grade sarcasm:

"(Existing Aderall XR clinical trial data), while statistically significant, does not demonstrate an effect that in any way supports the ’amazing transformation’ claim ... If you have data to support these claims, please submit them to FDA for review."

Now THAT I’d like to see ... "amazing transformation" as a clinical endpoint!

It’s definitely a shame that apparently a few "bad apple" marketers broke the rules and made the rest of us look rotten too. One of the followup comments to Ed’s story calls all marketing men "liars" (first of all, who said they are all men?!?) More and more, I hear product managers, their agencies, and even their L/M/R committees being asked to "push the envelope" ... so it’s really no wonder that stuff like this happens. But there are also plenty of pharma marketers that are in this business for the right reasons, and are ethical, responsible marketers. I am proud to work for several. Even on the days I get frustrated by the inconsistent interpretations of the rules.

Responsible marketers know where the lines are. Shire and the other companies cited apparently did not. Or they just didn’t care.

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