Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, 
I happened to hear physicians promoting off-label use of medical devices in scientific conferences or communications. I also see sometimes companies using quotes from KOLs which again make claims that are not substantiated by data or cleared/approved by the FDA. 

My guess is that some of these physicians may have a conflict of interests. I wonder where the line is between what is permissible and what is against the regulations. Is there any specific guidance on this topic?


Please advise,
Thanks

The answer is easier than it may appear.  There are no special exceptions for physicians.  What you just described is <g class="gr_ gr_175 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins doubleReplace replaceWithoutSep" id="175" data-gr-id="175">off-label</g> promotion.  A device company should have the same review and approval process for internally and externally generated labeling.  The same rules apply to a device manufacturer label, IFU, brochure, and their affiliated practitioner PPT presentation.

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Rob Yamashita
Grand Rapids MI
United States
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Original Message:
Sent: 03-Sep-2018 11:51
From: Anonymous Member
Subject: physicians promoting medical devices

This message was posted by a user wishing to remain anonymous

Hello,
I happened to hear physicians promoting off-label use of medical devices in scientific conferences or communications. I also see sometimes companies using quotes from KOLs which again make claims that are not substantiated by data or cleared/approved by the FDA.

My guess is that some of these physicians may have a conflict of interests. I wonder where the line is between what is permissible and what is against the regulations. Is there any specific guidance on this topic?


Please advise,
Thanks

FDA doesn't regulate physician communications at conferences etc. That said, they do regulate what companies can say, whether that route of communication is via a physician or not including KOL quotes. The various advertising and promotion guidances spell out FDA thinking on these topics to some extent.

FDA has, on occasion, gone more broadly after physician claims about specific products. Two device examples that come to mind are on the lap band device and on Lasik. They have issued warning letters on both these topics. It remains to be seen if those letters would be deemed allowable under their regulatory authorities though, as I'm not aware that the Curts have ruled on it.

g-

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Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 03-Sep-2018 11:51
From: Anonymous Member
Subject: physicians promoting medical devices

This message was posted by a user wishing to remain anonymous

Hello,
I happened to hear physicians promoting off-label use of medical devices in scientific conferences or communications. I also see sometimes companies using quotes from KOLs which again make claims that are not substantiated by data or cleared/approved by the FDA.

My guess is that some of these physicians may have a conflict of interests. I wonder where the line is between what is permissible and what is against the regulations. Is there any specific guidance on this topic?


Please advise,
Thanks