Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Urgent advice needed , please ,
If there's an incorrect claim on marketing material and is picked up by an agency resulting in a recall (correction of marketing materials and advisory notice)  for that jurisdiction , does this need to be reported to other agencies ( the correction having been completed ) ?

thanks​

First, determine if any other jurisdictions are (or may be) affected. Where were the incorrect materials distributed?

Once you know that, you can review each area's reporting rules, as well as any contractual reporting obligations you may have.

You may also need to explain to some jurisdictions why they are not affected, though that is usually a letter in response to a query rather than a formal report.

Then update your recall procedures, so you'll know how to respond promptly and correctly the next time something goes wrong.

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Anne LeBlanc
United States
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Original Message:
Sent: 11-Apr-2022 22:19
From: Anonymous Member
Subject: Incorrect claim on marketing materials

This message was posted by a user wishing to remain anonymous

Urgent advice needed , please ,
If there's an incorrect claim on marketing material and is picked up by an agency resulting in a recall (correction of marketing materials and advisory notice)  for that jurisdiction , does this need to be reported to other agencies ( the correction having been completed ) ?

thanks​

Dear Anonymous,

If the claim is indeed incorrect, then I would propose the company would not want marketing material out there that may be viewed as false and misleading and not backed by data.  I would also propose that tracking marketing materials with "incorrect and "corrected" information is a RA challenge and definitely not ideal. Other considerations are will the "claim" mislead physicians or patients, how will the company be viewed externally and why wouldn't the company globally correct a incorrect claim.  I would correct the claim globally and resubmit marketing material as appropriate along with a letter explaining the correction.  Your internal SOP and procedures on marketing material should clearly reflect this scenario.   

Best,

Dar

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Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
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Original Message:
Sent: 11-Apr-2022 22:19
From: Anonymous Member
Subject: Incorrect claim on marketing materials

This message was posted by a user wishing to remain anonymous

Urgent advice needed , please ,
If there's an incorrect claim on marketing material and is picked up by an agency resulting in a recall (correction of marketing materials and advisory notice)  for that jurisdiction , does this need to be reported to other agencies ( the correction having been completed ) ?

thanks​