Hey @tmcm

The nature of the dosing modifications and the manner in which they are presented, will impact the level of fair balance. A dosing tool with cautionary dosing modifications may be subject to the lowest level fair balance. If the modifications are positioned as a product benefit it will likely require highest level fair balance.

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 @username

An image of the device may still suggest its route of administration and therefore may not be acceptable. The proposed home setting would also have to be assessed to determine if it fully aligns with the complete administration instructions from the TMA. Based on the nuances of the image and variables needed for proper assessment, it may be beneficial to submit for an opinion prior to creating the full campaign.

Hey @username

A message of “Available in Canada” is not restricted to the one-year post marketing restrictions as it does not suggest that the product is “new”. It simply states that the product is available.

Hello @kshulist

When the piece speaks to what the drug is for (beyond what is consistent with the Part I indication), how it works, and/or its various features, the piece should contain safety information. The principle is that patient pieces should be balanced and complete. They should not be about overly selective presentations from part III of the PM.

Hey @justineeve

Please see code section 1.5E.

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.

Hello @tmcm

I’m going to assume that you are asking if this is acceptable to do. Key things to consider are that the formulary criteria should be a complete presentation of the coverage criteria (s.2.1), so a summary presentation would have to be considered complete on the face of the ad (the link to the full coverage would not be sufficient). Additionally, highlighting specific patient characteristics may be viewed as placing emphasis on those characteristics, which may require support. Similar concerns may arise with highlighting specific prior drug treatments. We would need to consider the specifics of the drug and the coverage criteria to determine if the summary is sufficient. Q&A 258 provides additional information as well as the advisory document Provincial Formulary Coverage Statements

Hey @andrewleeson

A properly executed pre-NOC editorial campaign discussing the current treatment options without alluding to future entrants and which does not suggest unmet need, could be done. In my experience, when manufacturers have submitted this sort of content in the past, it has generally been to show how the current treatment landscape falls short of needs or to showcase why a new option is required to close a gap of some sort. As neither of these are acceptable, it is generally better to exclude discussion of the current treatment landscape or at least keep in mind that substantial revision may be required. For additional information on execution see Pre-NOC Corporate/Editorial Communications and Q&A Disease awareness Pre-NOC. Keep in mind, that the editorial campaign should not contain branding elements of either Product A or future branding elements for Product B (including branding elements from other jurisdictions).

As this piece would fall within the scope of the PAAB Code, we will help ensure that there is no off-label promotions for Product-A when performing the review. Some things to look out for include, branding elements, and/or focusing on a particular therapeutic class or pathway that the sponsor has vested interest in.

@jennifer-carroll Thank you very much!

Afternoon @natbourre

Consumer regulations are in effect regardless of whether the company has a product in the specific class, or not. The copy should be reviewed and approved against the Distinction Between Advertising and Other Activities document. Mentioning a condition and one class of treatment would not meet the consumer brochure restrictions and therefore is unlikely to be considered acceptable. Additionally, the sponsor is still responsible for the acceptability of all comments, shares and comments on shares associated with social media. They will be expected to monitor and moderate to ensure compliance with consumer regulations.

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).

Hello @kshulist

Enrolling a patient in a support program means that the decision to prescribe the product has already been made (i.e. patient is on the drug). Additionally, given the type of information on the form (e.g., including dosing or monitoring info), the form is not considered promotional but rather administrative in nature. Given these two reasons, indication/FB is typically not required. However, should promotional messaging be added (in the context of an HCP completed PSP enrolment form), indication and fair balance would indeed be required. For a patient completed enrolment form, no promotional messages would be acceptable and therefore the form would be administrative.

Good morning @georgian21

When there are Canadian consensus guidelines, HCPs should be directed to those. As per the document “What constitutes current medical opinion & practice”, US or European guidelines can be used as additional support to Canadian guidelines when they are consistent. If there is copy that goes beyond the recommendations of the Canadian guidelines, or contains products not yet approved in Canada, we would question the inclusion.

Good Morning @tmcm

Market research can be used to support non-therapeutic, non-comparative claims about a patient support program. The last paragraph of Tips on Claims Relating to Patient Assistance Program provides guidance relevant to this question.

Good Morning @username

The overall context of a piece is always part of the consideration. Acceptable copy should be factual and complete. The copy “Back in Canada” on it’s own would not be clear or complete. It’s unclear why it was not in Canada? Similar questions would arise with “Available again to Canadians”. This copy completed with “after a voluntary recall” may be considered.