Regulatory Open Forum

Hi all,

Would appreciate if someone here could provide some lights on this. Our marketing department is preparing some presentation slides which contain technical and scientific data based on our products for the purpose of marketing in the US. The source of data and information is referenced to "Data on file at Company XXX" in which company XXX is my company. From regulatory perspectives I am wondering whether this will pose any issue in accordance with US FDA Guidance on promotional materials since the audience will not have public access to these files which are internal and controlled documents in the company. I won't have issues if these are referenced to peer reviewed publications in journal but citing them as "Data on file at Company XXX" I am not really sure, even if the audiences are healthcare professionals. If anyone here could point me to any specific US FDA Guidance that touches on marketing presentation slides that will be very useful. Thank you.

Best regards,
WeiBeng

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Wei-Beng,

It is a common practice for promotional materials to contain one or more references to "Data on File".   The FDA expectation and regulatory requirement is that the content in your materials is supported by appropriate evidence, usually substantial evidence from adequate and well-controlled trials - but the regulations do not speak to specifics on citation of those references, for example, data on file vs peer reviewed publications.  If FDA asked for that information (data on file), you would need to provide it (but they maintain confidentiality).  If a third party - like the audience you present to asks what the reference is - you would need to be prepared to explain to them what the data are and why you cannot provide it due to the content being proprietary or internal only content.  If you think about it - your NDA/BLA/PMA has a multitude of information in it - well beyond what your label might contain.  Much of that data is internal only and proprietary but may be acceptable to reference and you don't make your full NDA/BLA publicly accessible.

Happy to elaborate further if needed.
Sincerely,
Glenn Byrd

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
President, RAPS Board of Directors
Woodbine MD
United States
------------------------------

Original Message:
Sent: 08-Jul-2020 03:51
From: Wei-Beng Ng
Subject: US FDA Guidance on promotional/marketing materials in the form of presentation slides

Hi all,

Would appreciate if someone here could provide some lights on this. Our marketing department is preparing some presentation slides which contain technical and scientific data based on our products for the purpose of marketing in the US. The source of data and information is referenced to "Data on file at Company XXX" in which company XXX is my company. From regulatory perspectives I am wondering whether this will pose any issue in accordance with US FDA Guidance on promotional materials since the audience will not have public access to these files which are internal and controlled documents in the company. I won't have issues if these are referenced to peer reviewed publications in journal but citing them as "Data on file at Company XXX" I am not really sure, even if the audiences are healthcare professionals. If anyone here could point me to any specific US FDA Guidance that touches on marketing presentation slides that will be very useful. Thank you.

Best regards,
WeiBeng

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

This message was posted by a user wishing to remain anonymous

Is your product a device or drug? I think device since with drugs, promotional materials follow the label.
Original Message:
Sent: 08-Jul-2020 03:51
From: Wei-Beng Ng
Subject: US FDA Guidance on promotional/marketing materials in the form of presentation slides

Hi all,

Would appreciate if someone here could provide some lights on this. Our marketing department is preparing some presentation slides which contain technical and scientific data based on our products for the purpose of marketing in the US. The source of data and information is referenced to "Data on file at Company XXX" in which company XXX is my company. From regulatory perspectives I am wondering whether this will pose any issue in accordance with US FDA Guidance on promotional materials since the audience will not have public access to these files which are internal and controlled documents in the company. I won't have issues if these are referenced to peer reviewed publications in journal but citing them as "Data on file at Company XXX" I am not really sure, even if the audiences are healthcare professionals. If anyone here could point me to any specific US FDA Guidance that touches on marketing presentation slides that will be very useful. Thank you.

Best regards,
WeiBeng

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Doesn't matter if device or drug.  Both need to follow the label.  Just that drugs have specific CFR citations on promotion.  For devices, if you promote inconsistent with labeling, you run the very real likelihood that your are misbranding your device.  So if you apply drug rules to devices, you will be in a pretty good place.

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
President, RAPS Board of Directors
United States
------------------------------

Original Message:
Sent: 09-Jul-2020 09:26
From: Anonymous Member
Subject: US FDA Guidance on promotional/marketing materials in the form of presentation slides

This message was posted by a user wishing to remain anonymous

Is your product a device or drug? I think device since with drugs, promotional materials follow the label.
Original Message:
Sent: 08-Jul-2020 03:51
From: Wei-Beng Ng
Subject: US FDA Guidance on promotional/marketing materials in the form of presentation slides

Hi all,

Would appreciate if someone here could provide some lights on this. Our marketing department is preparing some presentation slides which contain technical and scientific data based on our products for the purpose of marketing in the US. The source of data and information is referenced to "Data on file at Company XXX" in which company XXX is my company. From regulatory perspectives I am wondering whether this will pose any issue in accordance with US FDA Guidance on promotional materials since the audience will not have public access to these files which are internal and controlled documents in the company. I won't have issues if these are referenced to peer reviewed publications in journal but citing them as "Data on file at Company XXX" I am not really sure, even if the audiences are healthcare professionals. If anyone here could point me to any specific US FDA Guidance that touches on marketing presentation slides that will be very useful. Thank you.

Best regards,
WeiBeng

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Dear all,

Thank vou for your advice. Much appreciated.

Best regards,

WeiBeng

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Original Message:
Sent: 10-Jul-2020 11:28
From: Glenn Byrd
Subject: US FDA Guidance on promotional/marketing materials in the form of presentation slides

Doesn't matter if device or drug.  Both need to follow the label.  Just that drugs have specific CFR citations on promotion.  For devices, if you promote inconsistent with labeling, you run the very real likelihood that your are misbranding your device.  So if you apply drug rules to devices, you will be in a pretty good place.

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
President, RAPS Board of Directors
United States

Original Message:
Sent: 09-Jul-2020 09:26
From: Anonymous Member
Subject: US FDA Guidance on promotional/marketing materials in the form of presentation slides

This message was posted by a user wishing to remain anonymous

Is your product a device or drug? I think device since with drugs, promotional materials follow the label.
Original Message:
Sent: 08-Jul-2020 03:51
From: Wei-Beng Ng
Subject: US FDA Guidance on promotional/marketing materials in the form of presentation slides

Hi all,

Would appreciate if someone here could provide some lights on this. Our marketing department is preparing some presentation slides which contain technical and scientific data based on our products for the purpose of marketing in the US. The source of data and information is referenced to "Data on file at Company XXX" in which company XXX is my company. From regulatory perspectives I am wondering whether this will pose any issue in accordance with US FDA Guidance on promotional materials since the audience will not have public access to these files which are internal and controlled documents in the company. I won't have issues if these are referenced to peer reviewed publications in journal but citing them as "Data on file at Company XXX" I am not really sure, even if the audiences are healthcare professionals. If anyone here could point me to any specific US FDA Guidance that touches on marketing presentation slides that will be very useful. Thank you.

Best regards,
WeiBeng

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------