FDA Guidance on Off-Label Communication, Part 2

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 happens when a company makes unsupported, deceptive, or completely false claims about a product? In your professional opinion, should we allow a company to advertise unapproved claims that haven’t gone through a formal review process? Is it a good thing or a bad thing? What else is important? What are the most important takeaways? Listen to this discussion after you’ve heard Part 1 and see what you think of off-label communication and the guidance. 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. Send us Fan Mail For more medtech news and information, visit

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FDA Guidance on Off-Label Communication, Part 2 is an episode from Medtech Matters by Medical Product Outsourcing.

This episode is 57:13 long.

This episode was published on May 30, 2025.

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