The legalization of off-label promotion: Vascular Solutions beat the FDA and what their victory means for medtech

Welcome to the Medsider interview series, a special new feature at MassDevice, which will appear regularly. All interviews are conducted by Scott Nelson, Founder of Medsider. We hope you enjoy them! For as long as I can remember, at every company meeting I’ve ever been to, the topic of off-label promotion is always covered.  Whether it was new-hire orientation, a national sales meeting, or some other large commercial event, the dissemination of off-label information was always presented as not only a fireable offense, but something that could get you thrown in jail.  C.R. Bard, Boston Scientific, Covidien, Medtronic.  Everyone considers this to be extremely important.  And rightfully so. BUT, doctors use medical devices off-label all the time.  If you go to any societal conference, physicians present off-label uses for medical devices on a regular basis.  In fact, talk to any KOL, and they think it’s almost humorous that medical device companies take off-label promotion so seriously. Because I’ve spent the majority of my medical device career in a sales or marketing capacity, I’ve always found this to be an interesting dynamic.  Our physician customers discuss and use our products off-label all the time.  But we can’t say anything?  If a doctor asks a question about an off-label use, mum is the word.  “Sorry Dr. Smith.  I can’t answer that question.  No information.  Nada.  Zilch.” However, the times are certainly changing.  In a recent lan...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog medsider Vascular Solutions Inc. Source Type: news