Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re continuing our conversation on off-label communication. In this part, we’re examining the downside or negative aspects of this practice. We cover potential concerns and scenarios to avoid. Specifically, the following questions are addressed:Mike, maybe you can kick things off with a very quick overview of what we previously covered in the first part of the conversation.Now getting into that downside I mentioned in my opening, what are the disadvantages of off-label communication? In other words, what’s potentially wrong with allowing manufacturers to advertise uncleared or unapproved product claims?Why are some (including some within the industry) opposed to giving manufacturers permission to advertise off-label claims?Do you have any examples you can share?Is it possible to find an appropriate balance between what claims should be vetted through the FDA and those that don’t need to be?What happen