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Shire Warning Letter Is About Content, Not Context

Over the past few days, much digital ink has been spilled over the warning letter Shire recently received for a promotional video that was uploaded to YouTube.  According to Pharmaceutical Executive and other sources, FDA told Shire that the company had overstated a series of claims made by celebrity spokesperson Ty Pennington in a company video.

I have received a number of questions about this event over the past few days.  My response has been this: the FDA warning letter focused on the content of the advertisement rather than the context.  While it is certainly interesting that FDA asked Shire to withdraw a YouTube video, the medium is less important to the agency than the message.  Shire was warned because it produced materials that did not contain adequate fair balance information, not because the video appeared on a video sharing Website.  

In a white paper published by my firm Envision Solutions, Cymfony and Seyfarth Shaw last year we made a similar argument. We said:

“Although the FDA has not released firm guidance on pharmaceutical Internet communications, we have many years of received precedent to guide us . . . At minimum, drug firms thinking about communicating via social media should design their programs to be consistent with . . . principles [such as fair balance, avoiding the dissemination of off-label information and reporting adverse events] and be ready to discuss their efforts with the FDA.”  

The recent FDA action supports our recommendation.

Overall, the warning letter has not made Shire gun-shy about alternative interactive media.  Company executive Matt Cabrey told Pharmaceutical Executive that Shire will continue to utilize these technologies to promote its products.  


1 Comments/Trackbacks


Your title said it all! However, this being the first time a YouTube video was references, people are only paying attention to that part of the story.

Eileen O'Brien
Compass Healthcare Communications
Princeton, NJ

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