FDA Guidance on Off-Label Communication, Part 2

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 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 [email protected], and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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