Guidance Document Content Flow

Purpose

This document is essentially a collection of examples.  Its purpose is to crystalize the principles in PAAB codes 4.4 & 7.3 and the concepts discussed in the PAAB guidance documents “Guidance on generating the three base fair balance levels (HCP advertising)” and “Guidance on base fair balance level selection and placement in Healthcare Professional APS”.  It is strongly recommended that you read those documents prior to reading the present document.

The Old

Figure 1 shows the 2012 Toviaz journal ad while Figure 2 shows the PI that this ad refers to.

Figure 1: Layout for the 2012 Toviaz journal ad (i.e. before the code change).

The fair balance is in the bottom left quadrant. Additionally, the icon in the extreme bottom right corner directs the reader to go to page 76 within the publication for the prescribing summary. Figure 2 is the prescribing summary spanning over 2 pages. This is what the reader would see upon arrival to page 76.

Figure 2: Toviaz 2012 Prescribing Summary (2 pages)

The web page at URL www.toviaz.ca/PM1583 in the Figure 3 fair balance is a hypothetical page on the HCP gated website www.toviaz.ca. Figure 4 shows an example of what this hypothetical web page could look like (for training purposes only, this webpage does not exist and has not been approved by Pfizer). Note that Toviaz does not have a July 2012 Dear HCP letter. The corresponding icon has been added for demonstration purposes only.

Figure 4: Hypothetical web link destination for Toviaz

As per PAAB code section 7.3, this page must be accessible without the need to enter a password.  This is possible as the APS containing the URL is distributed or made viewable in controlled fashion (i.e. targeted for HCPs).  The URL itself therefore acts as the key into the Toviaz website.  This is why you’ll note the URL is not simply www.toviaz.ca.  There is no need for PAAB review of this web page provided the content is limited to that listed in PAAB code section 7.3.2b.  The references and study parameters are reviewed within the context of the corresponding APS.

The reference list and the study parameters may appear in APS as in Figure 3.  However, they could have alternatively been moved to the web link destination as shown in Figure 5.  The click through to the TMA (and the Dear HCP letter if applicable) must be very prominent on the web link destination (e.g. large and the first item on the page).

Please note that the study parameters and the reference list may appear either on the face of the weblink destination (as in Figure 5) or they may be relegated to a click through button.

Figure 5: Hypothetical web link destination for Toviaz (with references & study parameters)

It is important to note that study parameters are the only footnotes which can be relegated to the web link destination.  Disclaimers and definitions, for example, must remain on the face of the ad (on the same surface as the claims they are qualifying) in order to satisfy PAAB code section 2.1.

Rather than the Toviaz website, the manufacturer could have used a URL leading directly to the  product monograph PDF document stored on the corporate website or to the Drug Product Directory search page on the Health Canada website.  This would impose some limitations on the manufacturer options vis-à-vis the reference list and study parameters.

Using middle level to lead to highest level fair balance

The APS in figure 3 employs the highest level fair balance as it has therapeutic claims. However, the manufacturer could instead choose to use middle fair balance on the face of the APS to direct the reader elsewhere to a surface which is easily accessible (e.g. same media) and conducive to easy reading.  In Figure 6, we’ve modified the Figure 3 APS to accomplish this.

Figure 6: Middle level used to direct the reader to highest level fair balance

When the reader goes to page XX, they’ll see Figure 7.  In this case, www.toviaz.ca/PM1583 would be figure 5. Note that the relevant page XX presentation should begin with the product logo so as to be easily located (and differentiated from other content on the page). 

As Toviaz does not have any emphasized warnings and precautions (e.g. bolded/boxed) or a long list of clinical use issues in the “Indication and Clinical Use” section of the product monograph, the benefits of using middle fair balance within the main advertising message to direct HCPs to the highest level elsewhere are not as pronounced as they would be for other products.

Figure 7: Highest fair balance placed elsewhere

This brings us to another potential location for references and study parameters. In Figure 8, we’ve added the references and study parameters to the surface containing the highest level fair balance (rather than keeping them on the ad or moving them to the web-link destination). In this case, www.toviaz.ca/PM1583 would be figure 4.

Figure 9 shows the minimum font sizes for content which does not appear on the face of the ad. These minimum requirements apply whether the content appears on the web link destination or elsewhere such as some other page within the publication. There are no minimum fair balance font sizes for content on the face of the ad (as fair balance size on the face of the ad should be comparable to the benefit copy font size). 

Figure 8: Highest fair balance placed elsewhere with references and parameters

Figure 9: Font sizes for content which is not located on the face of the ad

Other key uses for middle level leading to highest level fair balance

For a slide ruler (see figure 10) the main advertising area is generally confined to the external outer facing surfaces (front & back).  The ruler itself, which slides out, is not considered part of the main advertising surface.  The manufacturer has the option of placing middle level fair balance on the exterior directing the reader to remove the ruler in order to access the highest level fair balance.  It is possible that the ruler even unfolds thus offering a larger surface area.  The reader then folds the ruler and easily slides it back into the outer case for continued use of the tool.

Other tools like bellybands, shelf talkers and tent cards offer similar opportunities.

Figure 10: Slide ruler

The main advertising area on a sample holder (see figure 11) is generally confined to the front-facing and side-facing panels. The back panel is typically pushed up against the back of the cupboard wall. Middle level fair balance can be used on the front or side panels to direct the HCP to pull the holder out of the cupboard so as to view the back panel for the highest level fair balance.  Note that the highest level fair balance may not appear on the inside panels or the bottom panel as reading content on these surfaces would require awkward positioning or emptying of the sample tray.  For similar reasons, the highest level of fair balance could not appear on the top or bottom shelf talker surfaces which rest on the shelf (i.e. product would need to be removed to make the balance copy visible).      

Figure 11: Sample holder

Electronic banner ads in HCP gated environments which contain product claims require fair balance.  Relegating the fair balance to a click through would not meet this requirement as this would constitute separation of the claims from the fair balance.  However, middle fair balance may appear on the face of the banner with a click through directly to the highest fair balance. In such a case, the highest fair balance should be presented on the face of the weblink destination (i.e. the highest level fair balance should not be relegated to a button found on the weblink destination requiring additional click through).  Although this disqualifies the weblink destination from being exempt from preclearance, this option simplifies communication of therapeutic claims on banner ads.  Note that where multiple frames are used in the banner ad, the indication should appear on (or prior to) the first frame containing explicit marketing claims of benefit (refer to the document “Guidance on Indication Placement in Advertising”).

Please refer to the PAAB document “Guidance on base fair balance level selection and placement” for discussion on the use of middle fair balance on the homepage of product websites.

The Web Link Destination

The URL or electronic link can lead to any of the destination pages listed in PAAB code section 7.3.

Web link destinations on company/agent controlled product or corporate websites containing content which exceed the elements listed in 7.3.2b require PAAB review as a separate APS. All visible content on such pages (including but not limited to links and/or menu items) would be reviewed in the product branded context.