@jennifer-carroll sounds good, that is helpful to know.

Hey @natbourre

It appears that the intent is to develop a help-seeking message. What you’ve described does not meet the criteria of a help-seeking message per the Distinction Between Advertising and Other Activities as the addition of the company name would violate the requirements. The direct link to sites that only have the sponsors brand and listing the sponsors brand as what is offered at those sites would also brand the site.

If you are going the help-seeking route, all criteria listing in the distinction document should be followed.

Since this is a vaccine, DTC advertising which links the product to it’s therapeutic use could be considered. If this option is selected, all advertising regulations would be required to be met.

@abyscat

“The formulary status for Drug XYA has been updated” may potentially be exempt depending on the context in which it is presented. Our PAAB opinion service is available for exempt opinions.

@jennifer-carroll Thank you!

Hello @karen-taylor

Code section 1.4.D states “The Code applies to all Advertising/Promotion Systems and corporate messages directed to licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing, pharmacy and related health disciplines, to institutions, and to patient information that will be distributed by or recommended by a healthcare professional.”.

From the provided description, it appears that these pieces would be considered patient materials that are subject to the PAAB code.

Hello @danielle

Independent third party lifestyle apps may be promoted within branded apps if they do not contradict copy within the brands TMA. PAAB would ask to see the app content to ensure the link is acceptable.

The review of linked 3rd party apps focused on lifestyle and nutrition vs lifestyle, nutrition and disease information is not different however there is increased opportunity for content which is not acceptable to arise when disease information is discussed.

Additional clarification would be required on the last question that would be better suited for an opinion submission so that all aspects of the activity can be assessed. For example, is the 3rd party app only accessible through the PSP (not open to the public)? When this is the case, clarity over influence, sponsorship and distribution may impact if the content requires PAAB review.

Hey @natbourre

The answers to your questions hinge on whether the document is subject to the advertising provisions or not.

The assessment of whether it is subject to the advertising provisions is made by applying the following 7 questions from the Health Canada policy document “The Distinction Between Advertising and Other Activities”:
• What is the context in which the message is disseminated?
• Who are the primary and secondary audiences?
• Who delivers the message? (the provider)
• Who sponsors the message and how?
• What influence does the drug manufacturer have on the message content?
• What is the content of the message?
• With what frequency is the message delivered?

Assuming that the audience is HCPs, you would need to assess who sponsored the program; what influence did the manufacturer have; what is the content of the message across the program; and the frequency of the messages throughout the learning program. It is important to consider each question as no single factor can determine whether the advertising provisions apply. This assessment can be done internally through the manufacturer’s own regulatory department. If you would like, PAAB can provide an objective opinion on any particular tool/material based on the aforementioned Health Canada policy document. If the activity was deemed to be advertising, the pieces would be subject to the PAAB code.

Mention of the sponsor on content they create would be required unless precluded by other regulations (i.e. help seeking messages).

Hey @xian50

The type of information within the piece would be dependent on the type of review you are looking for. An RMT should convey important risk information about the manufacturers product. If the proposed “disease information” does not appear to serve the intent of an RMT, it may be questioned. This would be assessed during the review.

Patient information can contain disease information as well as risk information. Disease information which does not align with part III of the TMA would not be acceptable in the context of a branded patient information piece.

@natbourre

Thanks for your question.

If the device is a distinct Class I-IV “medical device”, it does not fall within the PAAB scope as defined in code section 1.3 and the definition of a “Health product” per PAAB scope in section 1.8.

If it is not a Class I-IV “medical device” and is an extension of the corresponding drug product, then the training material, directed to HCPs, would be subject to PAAB review.

Please also see PAAB Q&A #500 as well as this PAAB Forum post

Hi @alee,
Yes, radiopharmaceuticals are drug products that fall under the Scope of the Code. Please see Code sections 1.3 and 1.4, and particularly 1.8 (definition of “healthcare product” which is covered by the Code).

Good Morning @natbourre

Please see Q&A 634, particularly the PAAB Advisory Guidance on which HCP materials require PAAB review, which contains a decision tree to describe the key elements in the assessment. To make an assessment, we would require further elaboration on the content, nature of the sponsorship and selection of the author group. We would also require elaboration on the “3rd party distribution”. If the sponsor has influence on choosing the topic and/or plays a role in the distribution by the 3rd party, we would recommend submitting for an opinion. The opinion would be to assess the influence of the sponsorship (as noted in the above guidance, examples of “influence” include control or input on the specific topic, content, author selection, audience, frequency, etc.) and the overall message of the piece. The standard litmus test is “could a reader identify the sponsor” and “would a competitor be equally as likely to promote this tool”.

Hello @karen-taylor

Please see the response to Q&A Email update on CADTH recommendations. The letter of intent (LOI) is viewed similarly to the CADTH recommendation. It is not acceptable to position the pan-Canadian Pharmaceutical Alliance (pCPA) coverage negotiations as a positive feature of the product or suggest endorsement. Formulary messages should be restricted to clear, complete coverage criteria and not suggest the endorsement of a product.

Hi @smurcar

The addition of such content would prompt a new review as you are changing the piece.

While Class I-IV medical devices do not fall under the scope of PAAB review, the piece in question combines drug-related content and device-specific content. Any change to the former OR the latter would trigger the requirement for re-assessment. Changes in the device-specific content could potentially impair acceptability of the previously approved drug content through various contextual or linkage factors. Based on the information provided in the question, some of the key focuses of our review might include:

Whether the added content is indeed device-specific. Whether the drug-related and device-specific content are separate and distinct from each other. For example, the device-specific content must not impact the meaning/interpretation of the drug content through context or linkage. Whether the device-specific content suggests therapeutic outcomes or contains promotional claims for the drug brand. For example, if the claim was to state “Drug Brand X: pain free injections with S-pen”, we would question the link between the drug brand and “pain” in the absence of support. For copy to be considered “device” claims, it should be limited to the device and not positioned as a feature of the drug brand.

As the assessment is largely contextual in nature, references are not typically required for the Class I-IV medical device-specific content. Particularly as the manufacturer is solely responsible for ensuring that the medical device claims adhere with all applicable marketing rules and regulations. The reviewer will request references, on an as needed basis, wherever this content could potentially relate to the drug product.

Hi @nhem

Change to copy post approval generally requires a new file and new fee. In the scenario described above, it sounds as though one option from the drop-down menu will be removed/de-activated. PAAB does not require that all options within the drop-down options list, remain active. If that is the intent of the revision and question, it would not require resubmission. However, addition of new content (e.g. replacing or adding options) that requires assessment post-approval requires a new file and new fee. If we have not fully captured the request, please reach out to admin to set up a call with the reviewer. It may be easier to assess the actions when looking at the file in question.

Hello @brendaarmit1

Yes, a pharma company can send emails with CME event links, guidelines or journal articles. The important thing to note is that these may fall under “advertising activities” and require review. Please see Q&A 481 and 435 for additional considerations and guidance. Note that “linking” refers to any activity that could be perceived to create a connection between two separate activities. This includes sending emails in a predictive manner as part of a large campaign. Q&A 38 may also be of interest.

If you are unsure, you can submit for a PAAB opinion.

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.

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.

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.

Hello @username

The copy “Proven efficacy” CANNOT stand on it’s own. It must be immediately supported by the indication which sets the limitations of the copy ”proven efficacy” as assessed and authorized by Health Canada. The indication acts as the ‘supporting copy’. The copy “proven efficacy” should not appear above single study findings as it overstates the level of evidence of single past tense study findings.

“Proven safety” is not acceptable since it is absolute. One could use the copy “Proven safety profile” if it is immediately supported with the most common adverse events and percent incidences from the PM. This reflects the safety profile that Health Canada has assessed in order to grant market authorization.

Note that either example "Proven efficacy" or "Proven safety profile" would also prompt the inclusion of the highest level fair balance.

Good morning @karen-taylor

It is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods. The addition of a new boxed warning would be considered significant and require the proactive update of all pieces in a timely manner. See also Q&A 337