Forum

Hello @support
If we are to assume that this is in an HCP gated space, we would advise that claims should not directly/indirectly highlight things like the shortage of competitor(s). Instead, the message may focus on reminding the audience about the sponsor’s product and availability in the market. You correctly identified that it would not be exempt. The piece would be subject to the Code and would require lowest level fair balance if restricted to a product availability message.

Hey @Username

In the consumer space, a standalone message such as “Get Brand X” can be acceptable when used strictly as a DTC reminder ad. However, a URL is rarely a standalone message. Its acceptability depends on the entire ecosystem around it, including:
• the content that drives traffic to the URL
• the content on the landing page
• any content linked after the landing page
If those connections change the overall impression or strengthen the implied message beyond a reminder ad, the URL may no longer be acceptable.
Because of this, it’s essential to share all current and planned linked content during the review process. With the full context, the reviewer can guide you on whether the URL maintains an appropriate attitude of caution and meets PAAB requirements.
It’s also important that any new materials that will link to this URL clearly communicate that a linkage will occur, so PAAB can assess the combined effect.

Good Morning @MondayMover

In general, what people do is upload the “track changes” version between the original and updated PM. When there are multiple version updates, they provide (upload) the sequential PM track changes PDFs. You do not need to annotate each version of the TMA to the APS, only the most recent PM. In the case described, it sounds like there would be no annotations within the PM as no copy is referenced back to it. If that is the case, it’s likely sufficient to upload the most recent clean PM with an explanation of why the new TMA with annotated changes may not be necessary. Please feel free to reach out to admin for support during the submission process.

Hey @kshulist

1. Branded APS can present mortality/prognosis in general terms in the context of disease burden in an un-emphasized manner when there is no product data for mortality/survival, i.e. it is presented among a broad discussion of burdens including those that they have supporting product data for and there is a prominent disclosure included, indicating what the product has not demonstrated an effect in mortality/survival. Please see our disease burden document for additional information.
2. This is generally correct. Please see answer to question 1 above.
3. Yes, section 3 of the disease burden document provides the required references to establish the burden, e.g. authoritative consensus guidelines.

Hello @Manufacturer and @Agency ,

The PAAB remains committed to supporting our stakeholders with trusted, robust guidance that promotes excellence and compliance in healthcare communications. As part of this commitment, we are introducing an important update to how our informational and reference resources are accessed. Certain PAAB materials will now be available through a secure, gated platform. Users will be able to log in using their eFiles credentials, or create a new user account with their work email, to view or download select documents.

We’d like to share the reasons behind this update:

• Protecting intellectual property:
  PAAB’s materials reflect years of accumulated expertise, analysis, and refinement. Gated access helps distinguish PAAB intellectual property from other content.

• Preventing misuse and misinformation:
  PAAB resources are intended as guiding principles and tools but are not exhaustive contextual presentations of the application of the PAAB Code. Gated access helps reduce the risk of misinterpretation or inappropriate reuse, particularly as AI tools become more prevalent.

• Ensuring content accuracy and integrity:
  By managing access through a verified platform, we can better ensure that users are consulting the most current and accurate versions of our documents, minimizing the risk of outdated or misleading interpretations.

• Enhancing user experience:
  Over time, the platform will allow us to improve how resources are delivered, helping you access the most relevant information more efficiently.

Our goal is not to restrict access, but to safeguard the quality, credibility, and responsible use of the information PAAB provides.
This change supports our shared mission of fostering trustworthy communication in healthcare marketing and advertising.

We appreciate your understanding and partnership as we take this proactive step forward.

PAAB Team

Hello @Username

Is the product dual schedule or only “ethical”? Is it for the treatment of a schedule A disease?

One would need to consider schedule A and dual scheduling to establish which DTC regs are applicable (and consequently the degree to which they differ from HCP regs). If we assume the product is not dual scheduled and its use is not on schedule A, it is likely that the same imagery and heading can be used. However, there are instances where that is not the case because the HCP looks at the ad from a different vantage point as the general public (I.e. the same message can convey different/additional meaning for the HCP). Also, the HCP piece may contain different content that impacts the context in which the image and heading is interpreted.

One way to make sure the same image can be used is to submit an opinion to PAAB for the DTC along with the HCP piece.

Happy Almost Friday @Manufacturer and @Agency

Your PAAB Q3 Forum Review is now live!

Some of the things that you might want to check out:

• AI assisted submission process - Call for volunteers
• ARO expansion
• Client Messenger Service
• Creative Imagery Document Posted
• Coming soon: RWE formatting update, new service offerings, and more...

As always, thoughts and feedback are welcome below .
Thank you
PAAB

Good afternoon @Username

As previously noted in the question "Comparative therapeutic claims of schedule 2 products in DTC setting", the term “Schedule 2” is quite broad. Could you please clarify by specifying the federal drug schedule?

With respect to your question about whether there is a “clear regulation that would forbid DTC and HCP from having the same visual or headline,” this depends on how “clear” is interpreted. There is no direct statement in the Food and Drugs Act that explicitly addresses this scenario. However, the principles governing advertising regulations are outlined across several regulatory and guidance documents.

The nature of the claims and visuals would influence how such a case is assessed. Additionally, the idea that materials could be independently reviewed and approved by each “respective agency” may present challenges, as this would assume both agencies are aware of each other’s submissions, which is not always the case.

We would therefore recommend submitting the materials for an opinion to ensure clarity and alignment with the applicable standards.

Hey @charlton

Great question. You can provide a link to the HCP and to the patient. On the landing page, you can present the product name and the DIN login or HCP verification login. The site cannot link back to the parent company site or any site containing the PM. There should be no logo or promotional content on the pre-gate landing page. You also cannot use Search Engine Marketing (SEM).

Good Afternoon @Manufacturer and @Agency

Another quarter in the books. The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q3. See the Tag Report here and the CEI Report here.

Please share with colleagues and promote awareness that PAAB publishes these results quarterly. Remember that tags and the Customer Experience Index (CEI) are the most effective way to help PAAB track trends and improve experiences.

If there's more you'd like to know in Q4, let us know in the comments below. Hope you're enjoying the snow.

Thank you
PAAB

Hi @HollyMed

While this activity would be acceptable, the RMM/RMT requires PAAB review. MSLs are representatives of a company that has a vested interest in the health product. Having an MSL detail to an RMT renders the activity subject to advertising regulations. This amplification context differs from a reactive interaction, largely driven by the HCP, in which the MSL responds to an HCP’s one-on-one inquiries. As a reminder, Health Canada’s policy document “The Distinction Between Advertising and Other Activities” emphasizes that the determination of “advertising” versus “non-advertising/promotion” depends on the nature of the activity itself rather than on job titles assigned by the sponsor.

Regarding the second part, data presentations are not automatically compliant with advertising regulations simply because they pertain to risk. Compliance depends on multiple factors including (but not limited to) completeness, significance, context, and selectivity. Even data presented in a neutral tone can mislead if not balanced or contextualized appropriately. While the activity itself can be permissible, the slides require PAAB preclearance per the PAAB Code.

Hey @kshulist

Correct. You cannot speak to unmet need in a branded context.
Even if the drug is the first treatment for a certain condition, discussing “unmet need” suggests that the product addresses that need in an absolute manner. There are still ways to convey treatments where no options were previously available without stating “ need”. PAAB may be able to assist with the direction of messaging. Please reach out for additional assistance in a forum that allows for more specifics to be shared.

Hello @Maryssa

Great question as I can see where there might be some lack of clarity. The description of the “responsive ads” was intended to address the unique nature of these “small space ads”. Other parts of the Code and submissions guidance (including the Guidance document for Online Activities) continue to apply when there is targeting and/or keywords that cause the ad to surface. We have included the SEM and SEO in the same review efile as the Google responsive ads.

This previous PAAB Q&A also covers some general principles which may be useful.

Sorry @HollyMed this one slipped through the cracks.

Per the RMT guidance document, if the piece is intended to be detailed by a rep to an HCP, it requires going through the standard PAAB review process (i.e. the piece would be subject to all PAAB Code provisions relating to APS). Presentation of the safety data would be subject to the requirements of the PAAB Code. Give the above document a read and this Q&A and let us know if they answer is still unclear.

Hi there,

PAAB can provide approval to APS with links to PAAB acceptable pre-proof articles (see also Code section 3.1.2). However, it is the responsibility of the sponsor to ensure that there are no restrictions to the distribution of the pre-proof article prior to full publication (Code section 3.3).

This post was answered through our office earlier but we will post the answers here as well.

1. No, only opioids are subject to the Health Canada terms and conditions for advertising.
2. It is permissible to create promotional materials to HCPs for a controlled drug. However, note that direct to consumer advertising is not permitted.

This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”.

Let’s look at a few examples of where it would not be acceptable.

1. If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA.
2. If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”.
3. The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph.

If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)

Per Health Canada guidance, PSPs are not a type of additional Risk Minimization Measure/Tool, therefore, there should be no mention of the PSP within the RMT. Participation in the PSP should not be seen as a part of conditions for receiving the drug. Given this, the enrollment form question would be moot. Please, let us know if any new questions come up given the response.

Hey @dmauri, we haven't forgot about this question. It promoted an internal discussion to find the best solution moving forward. We'll look to get a full response posted some time next week. Thanks.

Hey @dlew
Coverage claims may be considered in HCP APS. Patient information should not contain promotional claims but formulary information may be considered. Please see our patient information guidance. HCP claims about “cost” should be factual and complete. A claim of “at zero additional cost for most patients” would be a hanging comparison and would need to clearly state versus what and be supportable across all public and private payers. Remember that formulary bodies have requested that messaging around coverage be limited to statements of coverage and not promotional messaging around “savings”. Additionally, messaging around cost should be clear about what costs (e.g. drug acquisition costs, mark-up, dispensing fee, etc.).

Private coverage claims can be supported by independent third party data from an established company who assess’ market access.