Yes, a compliant unbranded disease information pieces/tool could be created to be provided to patients by healthcare professionals. Patient information should be supported by consensus groups and authoritative sources. Guidelines are considered an acceptable source for disease targets in an unbranded patient piece.
If the visual does not allude to therapeutic use then it is likely exempt.
Note that when you link exempt content to advertising, the exempt content may no longer be exempt. If the booth contains promotional claims, it would be prudent to convey in the review of the booth, the content of the conference banner which is directing the user to the booth so that we may ensure it does not exceed the regulations.
Thank you for your question. The proposed APS does not meet exemption criteria as per Code section 1.5. It is considered a promotional message and would require PAAB review. As an advertising message, bolding may be possible depending on the context. The appropriateness would be determined during the review process.
The question above was interpreted as requesting clarification of the regulatory classification of the studies. While it did not specifically state that disease Z study was “ongoing” (the definition of this is critical – see below) , there are scenarios where an ongoing off-label study may be presented in APS, as well as scenarios where it must not be mentioned in APS. For further details of the discussion of ongoing studies, please see Code section 3.2.3 as well as Q&A 223 & Q&A 537
If the studies no longer qualify as ongoing (no longer in the data gather phase, or an interim analysis has been performed, data has been presented, etc.), the study cannot be discussed as it is considered off-label. There should be no pre-NOC advertising or off-label advertising. The crux of 3.2.3 is that it is non-promotional and intended only to outline the research the company is involved in.
The challenge with this copy is that you are forecasting future events. It is not acceptable to promote a milestone prior to achieving that milestone. We would recommend something similar to “Over 34 years of experience in Canada".
It may be possible for the company to promote this video, but the acceptability of this activity would be dependent on many factors that would be assessed during the review process. Material (APS) that a company creates to facilitate awareness of 3rd party videos would be subject to review and during that review, PAAB would ask to see the linked 3rd party content to assess the acceptability of the linkage. In summary, PAAB is reviewing the sponsor generated content that promotes the video, and the acceptability of linking that content to the 3rd party video. If the linkage is acceptable, the sponsor’s logo may appear on the APS.
Various ad sizes can result in changes to the ad that impact the acceptability of the ad. Things such as changes to the font size, flow of copy, content, images or amount of image captured in the ad. Decreasing the font size of copy that was acceptable in a “large” rectangle, to fit the “small” may result in copy that is illegible and therefore not acceptable. As a courtesy, don’t forget about the Guidance on Submission Process copy, “In campaigns involving multiple banner ads, the individual banner ads should be submitted in separate eFiles except in the following scenarios: they appear on the screen at the same time (e.g. a leaderboard ad paired with a skyscraper ad) they are less than 200 characters in length (in which case up to 10 banners can be submitted in the same efile e.g. Facebook banner ads”.
Upcoming updates to the submission system, that coincide with ARO, will enable submission of various ad sizes in a single eFile associated with the appropriate number of review fees.
This would be a review specific question. There are examples where this could be done (e.g. unbranded patient support program) and examples where this could not (e.g. brand specific support programs which directly/indirectly allude to therapeutic use (e.g. require selection of patient characteristics which could identify the therapeutic use and suggest off-label use for other products in the program which do not possess the same indication; linking therapeutic use to products which a patient has not been prescribed also contravenes DTCA regulations [Section C.01.044 of the Food and Drugs Act and Regulations]). It would be best to submit for an opinion or full review.
If the pack shot does not contain copy/visuals which would render the piece reviewable, it may be exempt. Some examples of copy on the pack shot which could render the piece reviewable would be showing a device, drug classification, stating “oral”, dosing, or administration instructions.
The use of a headline in a DTC campaign does not, in and of itself, prohibit its use in an HCP ad. The regulations for DTC advertising and HCP advertising vary and may impact the acceptability of copy depending on the context and audience. For clarity and completeness, we suggest being transparent about the use in the DTC campaign when submitting the HCP campaign for review.
You are correct that the non-selective addition of tabs for each heading throughout the product monograph, would not require submission to PAAB. The addition of branding colours to those tabs, in the manner described in your question, would not cause the document to require PAAB review. Any further modification may require the submission.
We recommend naming the document a Promotional/Clinical Monograph as it would appear from your description that the control number should be removed.
Modification limited to the addition of non-selective tabs, would not prompt the inclusion of fair balance. Note that changing the cover (beyond the control number removal) such as adding branding colours, elements, logos, would prompt review.
PAAB Code section 5.1 states “The compared drugs/products have an authorized indication for use in common, and the comparison is related to that use; or, in addition to the common indication for use, a second authorized indication is claimed as an added benefit of the advertised drug”. As such, this type of comparison would not be acceptable.
The fact that a website is created and controlled by a drug manufacturer’s parent company, outside of Canada, does not in and of itself render it exempt from Canadian drug advertising regulations (and the PAAB code). Even if the website URL is provided in a reactive manner, that website is likely subject to the regulations since the information that is available on the site far exceeds the question that prompted the URL to be shared.
The proposed activity could be considered exempt from the PAAB Code, PAAB Preclearance, and Canadian regulations if the mechanisms outlined in Q&A 176 were implemented. These mechanisms are provided to ensure the information provided is in response to the specific question asked. If all guiding principles from Q&A 176 are followed, this could be considered.
The PAAB can provide guidance on setting up a platform such as this, in the context of an opinion file.
As a reminder, one key aspect of the mechanism outlined, is “restricted access”. Canadians who are not HCPs must not have access to the site.
The APS category helps us to track the types of tools being submitted and reviewed. They also provide context on if they are to be rep-directed or self-directed. This can have implications for the flow of the piece. In theory, an approved slide deck can be shared after the presentation, with the assumption that if there are speaker notes, they have been reviewed and approved as part of the piece. You should also consider how you disseminate the presentation, with additional guidance in the “Dissemination” section of the PAAB Clarification regarding digitization of APS Helping healthcare product manufacturers plan for the evolving COVID-19 operational context document.
If the presentation is to be recorded and distributed, this recording would require a separate review prior to being distributed. See paab.ca/myths (5) for further elaboration