In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the off-label use of a medical device. It would seem to go against FDA regulation to do so, but there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, the following questions are addressed:
- Since this discussion came out of the last podcast on intended use, can you give a very quick summation of that rule?
- Can you speak to the relationship between intended use and off-label use?
- When it comes to a medical device manufacturer promoting the off-label use of a device, how can that happen without raising a red flag with the FDA?
- To what degree can a promotion take place? Could it be an advertisement, collateral material provided to a doctor, or messaging from a sales person? Or all of the above?
- Can you share a couple real-world examples of acceptable off-label promotion?
- Where is the cut-off? In other words, what should companies be sure they AREN’T doing with regard to off-label promotion?
- What are the most important takeaways with all of this for medical device manufacturers?
Listen to this episode and see if you’re able to promote an off-label use of one of your devices. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.
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