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Hi @dmauri
This would not apply to comparative data. As per the first sentence “statistical analysis to support inclusion of comparative therapeutic data” is required. The comment also states that the AEs have to be aligned. Your original question appears to suggest that you are looking to speak to AEs which are not presented in the TMA and therefore would be difficult to demonstrate alignment.
Hey @dmauri
Please see PAAB Q&A 427.
In summary, as per PAAB code section 5.9 and 5.7, when a side-by-side comparative presentation of out-of-TMA safety profile data is desired, a head-to-head RCT with demonstrated statistical analyses between the adverse events that are being compared should be provided as substantiation. In cases where such substantiation is not available, a comparative presentation would not be acceptable. Note that PAAB can consider a neutral comparative side-by-side AE presentation without statistical analysis or conclusion, if it exists in the TMA.
Apologies for the delay @SMurcar. We were in the process of upgrading the forum over the last two days.
As the piece would be moving from two sided to one sided this would change the flow. The content in the top section may set context for the bottom section depending on the formatting and flow. We would suggest submitting for a minor update (if the resizing is intended to replace the small postcard altogether) so that we can assess the revised visual flow to ensure all aspects of the Code remain met.
The addition of the QR code as described above could be considered as a minor update. Please see the Submission Guidelines for more information
Hey @cscholes
We understand that LinkedIn is an ungated platform and open to consumers. As such, the site is subject to consumer regulations similar to PF question 458 and is highly restricted for prescription advertising. Targeting to HCPs within the open platform may not guarantee that consumers won’t see the ad as well. Please also see this linked PF question and our Guidance on Gating Mechanisms for Healthcare Professional Targeted Digital Assets and subsequent clarification document Gating Mechanisms for HCP Digital Assets (designed in collaboration with Health Canada) regarding HCP validation. How HCPs are identified and verified, the nature of the targeting and how well it can limit the audience to only validated HCPs would be information that is required as part of the review process. PAAB will provide advice and direction based on the Health Canada DTC regulations, the PAAB code principles and the information that the sponsor can provide for the restriction of the intended HCP audience within this consumer space.
Hey @mimi77
This sounds like a file specific question which should be addressed with the review through the eFiles ticket system. If the question is with respect to “attestation letters” in general term, there are many different reasons an attestation letter might be required in a file. The person signing the attestation letter can vary depending on the copy. Most commonly attestation letters are signed by a representative of the manufacturer’s medical or regulatory team. It may be possible for it to be a representative from the global team. There are a number of Q&As which address attestations which may also support your understanding.
Hello @tk2022
It appears that you are asking for an exempt review over the forum. Please note that this is not the intention of the forum. From a search it appears that you are taking the term “simple sample” from Question 47 or 58. If this is the case, please ask the question under the relevant Q&A in the future to help maintain the usability and clarity of the Forum. Q&A Solicit product samples should provide sufficient information along with the referenced questions within that response, to assess “simple”. When unsure, please be invited to submit for an opinion.
When an APS has more than one audience, all regulations for each audience apply. The tool would be reviewed to ensure it meets patient and HCP regulations. Generally the patient regulations are more stringent so we recommend strongly considering them when creating the tool.
Hi @hollymed
Please see this PAAB Forum Q&A
Per the Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc “3. For NOC/c product advertising, studies and/or data which are not presented in the Terms of Market Authorization will not be accepted.” Please note that this does not state “verbatim”. However, it should be interpreted to mean that no data from outside of the PM can be presented.
Hello @laraholmes
If the form has been reviewed and approved for a patient audience, and the user has verified themselves as a patient by an appropriate gating mechanism, no reason that it could not be included post-gate on the patient website site jumps out.
Hello @mimi77
Promotion of a patient support program through the presentation of the program name and logo does not fall under the exemption criteria and links the brand logo to promotion of a company service (PSP logo) (Code section 7.5). Additionally, program names often have implications for the brand such as alluding to therapeutic use. Exemption is limited to brand name and logo in a context not linked to therapeutic or promotional messages per Code section 1.5.
Hello @lora_nolan
This is a review question. Per the Community Guidelines (see top right corner), this does not meet the use conditions for the Forum. Please address review questions through the appropriate channels by submitting a ticket for a call with the Reviewer through eFiles.
Hello @gmc
Hard to say whether this is even acceptable without looking at the study, but as a general question, we can state that this would require highest level fair balance. It is an implied claim of efficacy which would likely require quantification from the study (i.e., presentation of data). If it was stopped due to safety concerns, that would also prompt inclusion of that information and render it subject to highest level fair balance. With respect to “what other data is required for it’s inclusion?”, this is a review specific question. Please submit for an opinion as there are a number of factors that would need to be considered.
Good Morning @ebailey
All files do not need to come back together. You can update the parent file and then apply across all the children files. In general, the parent file should be the one being resubmitted; however we understand that there may be practical reasons to resubmit a child file to get it to approval prior to proceeding with the rest of the children and the parent. When this is the case, please outline this for the reviewer. You may also reach out with an email to admin to confirm that the reviewers agree prior to resubmission.
Hey @supriya
We’re unclear about the request. We can provide an example of how to cross-reference:
Insert an asterisk ( * ) at the point in the text where you want to reference the footnote.
At the bottom of the page, add the corresponding footnote, also marked with an asterisk ( * ).
Cross-references must appear on the same spread as the claim.
Multiple claims can be linked to the same footnote if the footnote would be the same for each claim.
If this is not the question, can you please provide additional context.
Hello @Manufacturer and @Agency
PAAB would like to proactively inform our clients that messages of “Made in Canada” and “Product of Canada” can be submitted as FYIs when specified conditions are met. To learn more about the details and a reminder on the FYI process, please visit the PAAB resource page “Product of Canada” and “Made in Canada”.
If you have any clarifying questions or comments, we invite you to post them below.
Thank you.
Hey @laraholmes
The term ‘nominal’ is often used for a p-value that is not adjusted for multiplicity but there are other scenarios. We would need to assess the study design and nature of the statistical outcome. As a general rule of thumb, a claim neutral presentation, given statistical significance of the primary, and if meeting all other aspects of the Code, could be considered. Clear disclosure of the nature of the p-value would be required.
Morning @constance
If the product has not received NOC, a manufacturer cannot promote that a new indication is coming soon as this would be off-label promotion.
Good morning @tbalzarini
It is acceptable to have the product name, dosage strengths/quantity, form, and a picture of the species which the drug is indicated in provided the picture does not allude to the therapeutic use (e.g., magnified ticks on a dog).
The images uploaded cross into advertising with the inclusion of the product class (i.e. Immunomodulator (Janus Kinase Inhibitor)) and the identification of use which appears in the second set of images (images down the right side for various pests/worms). When pack shots contain copy which exceeds name, price, and quantity, this copy should be blurred to prevent advertising to the general public.
We have not provided an exhaustive review of the provided ads as not all copy is legible.
Hello @laraholmes
Let’s break the q’s down for simplicity:
Is patient consent information required to be clearly, visually separated from HCP information on a PSP form?
a. Yes
I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient?
a. We cannot comment on examples that we have not seen. From a general questions perspective, we can state that patients should not be exposed to healthcare professional advertising. We have seen scenarios where the use and training of the tool have been restricted to only showing the patient the section they are intended to sign as “consent”. In some cases, consent is strictly verbal and therefore the patient would not be privy to the other copy on the piece. We’re happy to have a conversation discussing specific pieces if you’d like to reach out to info@paab.ca.
I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?
a. This appears to be a specific comment about a specific file. The clarifying question should be asked in the context of that file and review since various factors may be taken into consideration. As a general response to a general question, note that part I of the TMA is intended for healthcare professionals. Part III contains the indication in a format that has been deemed to be appropriate for patients. The use of language often varies between the two sections of the TMA based on the intended audience.
Hope that helps. As a courtesy, please remember that the forum is a courtesy service. While we do our best to respond within one business day, we have competing priorities. If you require a more timely response, please submit a request for a general ticket call.
