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
7 Comments
Lets file that under.....so what were they thinking...
Just goes to tell you how well these District managers are trained. Or are they sure there is no way they can get in trouble. Maybe the regional director dreamed it up.
Given how much pharma has beaten its sales forces into complance submission I am wondering what is different in the culture of WC for something this egregious to happen. This type of compliance violation would not have been acceptable enven in the 1990s, let alone today.
This is par for the course with WC. Warner Chilcott is one of only a few pharmaceutical companies that has not signed the PHARMA guidelines. Therefore, employees can and are required to take doctors out to expensive dinners multiple times a week. There is an atmosphere of pushing the envelope of approvable sales content and selling materials. It would not take much digging to uncover these things.
THIS JUST GOES TO SHOW ONE HOW LITTLE THIS REP AND HER PEERS HAVE TO OFFER PHYSICIANS. THE PROFESSIONALISM HAS VANISHED FROM THE INDUSTRY. JUST ASK ANY PHYSICIAND THAT CARES.
I wonder how many views the video got before FDA saw it and sent out the letter.
If her actions were sanctioned or even mandated by the company, then I'd say, "perhaps this is not a good idea", as it represents the approach of a greater entity, Warner Chilcott.
If she thought of it on her own, she might be somebody I would hire. That's pretty creative.