Should sales reps post their own promotional videos on You Tube? If this sounds like something less than a good idea, the FDA would agree. But this is exactly what one Warner Chilcott sales rep apparently did - and at the direction of her district manager. How do we know? The FDA has sent a letter to Warner Chilcott saying the video was the subject of a Bad Ad complaint.
The 60-second spot was entitled 'Brooke Stacey SA, TX Atelvia' and was designed to promote the Atelvia med for treating osteoporosis in postmenopausal women. The video opens with a camera points to a staff member in the reception area of a physician’s office. Off camera, the sales rep says she is visiting a doc to discuss Atelvia and makes claims about dosing benefits to the staffer.
"This generates an enthusiastic response from the staff member about Atelvia’s dosing. The sales representative and staff member continue their spirited conversation, with the sales representative stating 'So we have a...new start with Atelvia..." and turning the camera to herself to close the video, according to the FDA letter to Warner-Chilcott (read here). And just like that, a star is born.
But so is a regulatory gaffe. The sales rep forgot something. The video, which has since been taken down, was misleading because it failed to communicate any risks associated with its use, including contraindications, warnings and precautions, or adverse reactions. "By omitting this important risk information, the video misleadingly suggests that Atelvia is safer than has been demonstrated. Furthermore, the video fails to communicate the indication for Atelvia," the FDA wrote.
The sales rep and her district manager also failed to submit the video to the FDA for viewing, as required. Any good director would know that a flick should be screened before an appropriate audience before going public, yes? We asked Warner Chilcott for comment and will update you accordingly.
pic thx to woodleywonderworks on flicrk