Drug companies should not let overeager sales representatives make do-it-yourself Web videos and post them online without review by compliance experts.
Duh.
Warner Chilcott received for a notice of violation letter for a sales-rep-created-and-produced YouTube video promoting its new osteoporosis drug Atelvia (risedronate delayed-release), which featured a female sales representative talking about the drug to an enthusiastic staff member in a physician's office.
The letter was generated by a "Bad Ad" program complaint, and FDA noted that the video was never submitted via a FDA Form 2253 as required.
Oops.
According to the May 5 NOV letter to Warner Chilcott, which was posted to the FDA Web site May 9, "The video was posted by the sales representative on the website YouTube.com under the direction of a Warner Chilcott district manager."
Please note that this does not mean that YouTube is out of bounds. It's not the channel that's non-compliant, it's the content.
Sins of omission are seldom fun.
