Good morning @gmc

Similar to Q&A 332, p=ns data from the PM clinical trials section may be included in advertising providing there are no conclusions or claims that extend beyond that found in the PM. This is possible regardless of whether it is primary, secondary or exploratory.

Hello @hannah

There is insufficient information to determine if the data would be considered off-label, but there is sufficient information to determine that it would not be acceptable data as post-hoc analyses are not considered high quality evidence. Per code section 3.1.1, clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, and observational studies are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable. As the data on file in this case is not in the TMA (PM), it is not acceptable for advertising claims.

Hello @natbourre

Patient organizations generally package complex information in a manner that is more easily understood by the general public. HCPs should be directed to information that was written with a higher complexity intended for more specialized consumption like recognized healthcare professional organizations or medical textbooks.

A statement referring to the sheet would need to be clear that it is for consumers or is patient information not designed for healthcare professionals. PAAB would need to assess the linkage to ensure that it is not overtly off-label.

Good afternoon @gmc

The form is not exempt as service oriented messages to patients/HCPs are still subject to review. See FB on PSP enrolment forms for related information.

Hello @gmc

No. This would not meet the specifications outlined in Guidance on Generating the Three Levels of Fair Balance

Hey @tmcm

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.

Hello @tmcm

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.

@tmcm

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.

Hello @Lags

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.

Hey @tmcm
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".

Good Morning @georgian21

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.

Of course @brendaarmit1 .

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.

Hey @tmcm

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.

Good morning @tmcm

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.

Hello @tmcm

It is not that the website described is exempt from requiring a gate, it is that the controlled distribution of a de-indexed URL would be considered an acceptable gating mechanism.

Hi @tmcm

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.

Hello @tmcm

If the video is a looping video that is clearly designed as one piece for the copromotion of the three brands, it could be considered as one file.

Hey @keoca

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.

Good morning @keoca

The inclusion of the brand logo and PM, as well as a corporate message, is likely subject to review (would not meet exemption per code section 1.5E).