Social Media: Why Bother Issuing Guidance When You Can Issue Untitled Letters?

May 10, 2011

By Jeffrey N. Wasserstein

As aficionados of  all things social media (see our prior postings here, here, here, and here) (other than kitten videos, enough with those already!) we couldn’t help but notice a recent Untitled Letter to Warner Chilcott, LLC, relating to a YouTube video.  A product of DDMAC’s Bad Ad campaign, the letter describes a video created and posted by a sales representative at the direction of a district manager, in which the sales representative describes attributes of the drug Atelvia (risedronate sodium) to a staff member in a physician’s office.  The staff member apparently reacted enthusiastically to the description of the dosing (presumably, more enthusiastically than David After the Dentist).  We’ll never know how enthusiastic the response was, since the video has long since been pulled off of YouTube.

FDA complained that notwithstanding the existence of promotional claims for Atelvia in the video, the video omitted any reference to risks associated with its use as well as the indication.  The video also made misleading claims regarding dosing.  And, to top it all off, as one would expect with a homemade video, it had not been submitted to DDMAC at the time of initial dissemination.

The tweak at FDA in the blogpost title is admittedly gratuitous in this case.  Companies should know by now that videos on YouTube have to comply with the same promotional requirements as any other piece of promotional labeling or advertising.  The use of new media does not excuse compliance with existing promotional rules.