Updating your copy deck submissions to include document name and description

What does this mean?

With the increase in digital activities to address reduced in-person access to healthcare professionals, many APSs are being repurposed from a print format to a digital format or are being attached as digital downloads. In these situations, APSs are given document names and/or descriptions to identify them.

Why should we consider this?

The PAAB has seen an increase in the use of document names and/or descriptions that have not been reviewed during the preclearance process and do not meet the "name convention" requirements outlined in Clarification regarding of digitization of APS. This has resulted in a number of advertising violations.

We recommend including this information as part of the original submission for the APS. This avoids the need to create a new submission specifically for the review of the document name and/or description at a later date when, for example, you wish to add the APS as an attachment to an email, as a downloadable item in the CPS or “resource library” on your website, etc.

What should we keep in mind?

The places in which these document names and descriptions are presented often do not contain enough space for indications and fair balance. Therefore, we recommend keeping the name and descriptions claim neutral (no direct or implied therapeutic mention). 

Below are some examples of submitted content and how the addition of these fields on your copy deck, can help reduce delays moving forward. 

Example 1:

Current copy deck:

Content provided for digital attachment:

The document description contains a therapeutic message that requires indication and fair balance to be presented. It is not acceptable when it stands alone. Please note that content within the downloadable document is insufficient to address this issue.

Example 2:

Current copy deck:

Content provided for digital attachment:

The document name is an incomplete claim (#1 dispensed in what market segment?) which, furthermore, requires indication, fair balance and reference list to be presented. It is not acceptable when it stands alone. Please note that the content within the downloadable document is insufficient to address this issue.

Example 3:

Revised copydeck submission:

Content provided for digital attachment:

The document name and description are acceptable when they stand alone.

* VERANT is a fictitious healthcare product