We have produced the following to reiterate the PAAB Code and Guidance principles that are most relevant to small space ads†. It has been brought to our attention that these ads are often smaller in practice than they appear when submitted through the eFiles system in PDF format. We have noted instances in which the indication, risk information, and/or other qualifiers are difficult to read in the live web environment, even though these same elements were easy to read during the preclearance review.
The requirements of the Food and Drug Act section 9(1): No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Omitting or downplaying the risk associated with a product is not acceptable.
Indication, risk information and/or other qualifiers should be:
- Legible with no additional effort
- Accessible in the same manner as the claims
- Presented with visual treatment and emphasis that is comparable to the claim copy
In order to facilitate this, please ensure all pieces meet the following standards:
To create standardization, the PAAB will be viewing ads at 100% scale on a 15 inch monitor with display resolution 1920 x 1080.
- PAAB eFiles system will start accepting JPEG format files (expected mid April). To standardize the viewing experience, please ensure that images are saved web ready to open at the correct dimensions.
- For multi-frame ads, the JPEGs should be submitted in a series of labeled APS to mark the correct order.
- New JPEGs will only be required for affected frames.
- PDF format may still be requested, as needed, to show all frames in order, however JPEGs will be required for each individual frame for final approval.
Font size and contrast:
- The font size for balancing and qualifying information must be legible without any additional effort. This includes zooming or expanding the ad.
- Rationale: The claims of product benefit were accessible with no additional effort; the risk information should be no different.
- In addition to the standard font treatment guidelines outlined in Guidance on indication and fair balance font size and Guidance on indication placement in advertising (see Section 5: Contrast and Font Size), please consider the following best practices:
- Font should be no less than 14points. If the font is particularly difficult to read (such as FUTURA or narrow, condensed, poor contrast etc.) an increased size or font weighting may be warranted.
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Contrast can affect legibility. The Web Content Accessibility Guidelines (WCAG) section 2.0, 1.4.3, referenced in AODA, recommends the following luminosity ratio standard of 4.5:1 for main text and 3:1 for large-scale text (generally 18 points+, or 14 points+ bold)
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Time on Screen (rotating ad dwell time):
- The sponsor must attest to the fact that each frame of an ad remains on the screen for a sufficient amount of time for the average person to consume the entirety of the copy within the first rotation.
- Application: The average person reads 200-250 words a minute. Please apply 4 words per 1 second as a standard rule of thumb. This should include disclaimers and footnotes.
- Rationale: A reader should not have to wait for the frame to return in order to complete their understanding of the indication or risk information.
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- Indication statement must be presented on or prior to the first frame which links the brand to a marketing benefit claim.
- Rationale: PAAB code 2.10.1: “Any content setting the boundaries for patient selection from the Indications and Clinical Use section of the Product Monograph (or equivalent section of other TMA types) must be presented prominently among, or prior to, the first set of marketing benefit.”
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- It could be acceptable to have the indication spread over multiple frames if:
- There are no claims presented prior to the completion of the indication AND
- It is clear to the reader that there is more copy to complete the indication.
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Indication/fair balance placement:
- When pairing a static ad and rotating ads (two separate frames on the same screen at the same time), if the claims are on the static ad, the risk balance information should also appear on the static part. It may not appear on the rotating ad.
- Rationale: The risk information should not be downplayed and placement on a transient screen while the promotional message is consistently present (static), would suggest reduced importance.
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- When an ad contains static and rotating content (such as a scrollable field), the fair balance should appear on the static part of the ad.
- Rationale: It is not acceptable to have the risk balance information appear transient (the user would have to scroll to consume) while the user is always exposed to the marketing messages without requiring additional action.
- Non-continuous rotating banners: If a rotating banner ad eventually times out (stops rotating), the last frame should meet one of the following options:
- A) contains the appropriate level fair balance for the ad frame
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- B) contains the lowest level fair balance with no other claims
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- C) i) Contains no claims or
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ii) only claims which would be deemed to be exempt from preclearance as stand-alone messages (see PAAB Code section 1.5D)
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Designing for High-Resolution Displays vs. Normal Display
- Everything should be scaled/enhanced etc. proportionally. If you are increasing the pixel count in the same screen surface area, then the pixel count for the fair balance font should be increased similarly.
Size and scaling:
- Submissions should clearly outline the final display size (i.e. 300x250; 790x50 etc.). The onus has been and will continue to be on the client to ensure that the copy is legible upon distribution in the market.
- FYIs allow for “Directly proportional resize of APS that results in NO layout/flow/content/functionality changes”. However, scaling that impairs the legibility of qualifiers or fair balance cannot be considered an “FYI” and would contravene the PAAB Code.
- Thumbnail size can vary across platforms and applications. The standard principles mentioned above around legibility and completeness of the message should be applied to thumbnails as well. This means that if implicit or explicit claims are visible in the thumbnail, the support and balance copy must also be visible and legible. In instances where this is not possible, the claims should be blurred out.
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If space is insufficient for the required risk information to be presented in the manner described above, the APS claims must be revised to enable use of a lower level of fair balance disclosure.
Previously approved APS that are impacted by this advisory will require revision upon renewal.
**Additional guidance: Don’t forget PAAB Logo Guidelines – Appendix Logo minimum size guidelines**