How Can Off-Label Use Be Promoted?—Mike on Medtech

How Can Off-Label Use Be Promoted?—Mike on Medtech

Mike Drues and Sean Fenske look at the promotion of off-label use for a medical device and the ways in which it can be done successfully.

By Sean Fenske, Editor-in-Chief11.15.22
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.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Click here to review other podcasts.