Forum

Hey @Supriya

This appears to be a specific question about a specific piece. The piece should be submitted for assessment. The forum is for general questions. As an example, a general question here might be “Is the inclusion of an indication statement required in materials directed exclusively to healthcare professionals, where no therapeutic or pharmacologic claims are presented”. The answer to this question would be, that the indication is not required when there are no marketing benefit or therapeutic claims (see Marketing benefit claims: What are they and what level of support do they require?).

Good Morning @Constance
PAAB would need additional information to make the assessment of the claim proposed above. There are many considerations outside of just the source such as, does it suggest equivalence between products on a per unit basis and what is the intent of the per unit comparison. Given these unknowns, it is difficult to provide a definitive answer in a general space. We suggest submitting the copy for review.

Hey @GMC
This copy would be reviewed in the context of the entirety of the piece. The context of the message “dispensed as written” will matter. See also the PAAB advisory on Advertising messages referring to "no sub".

Hey @mhouzer

The difference between the Standard 4-day initial review of RMTs and submitting as an ARO-4 is that the subsequent revision turnaround time will be an expedited 2-days rather than the standard 3-days. If you anticipate needing a few rounds of back and forth, this can be a good option to get to your final letter more quickly.

AI MODEL - Phase I Testing Opt-In Deadline!

@Manufacturer the Pharmaceutical Advertising Advisory Board (PAAB) is taking a significant step forward in innovation by launching the first phase of testing of our ground-breaking AI model on live files starting May 1st.

On April 1st, in preparation for launch, we sent an eblast to industry announcing the deadline for full opt-in was now set for May 1st. Manufacturers who opt-in after the May 1st deadline will likely need to wait until a sufficient number of additional opt-ins are accumulated. This grouping of late opt-ins is intended to support cost-effectiveness.

This initiative marks a major milestone in enhancing the efficiency, consistency, and effectiveness of advertising review processes for our industry. Ensuring that preclearance keeps pace with the speed and quantity of specialization afforded through AI adoption across the industry.

If you have not yet reached out to PAAB and want to be among the first to experience the benefits of this exciting new project, please contact info@paab.ca today.

@Agency we'll be reaching out shortly for your collaboration on the AI driven augmentation of the submission process.

Cheers
PAAAB

Good Morning @HollyMed

Pooled data is not acceptable even if part of a pre-planned long-term extension study.

Good Morning @Supriya

We assume that you are referring to a patient targeted APS. As a patient would not have a prescription for all the products, this would contravene the direct-to-consumer advertising (DTCA) regulations (Section C.01.044 of the Food and Drugs Act Regulations) to create a link to the therapeutic use (i.e. indication could not be included) for products they are not prescribed. While the three base levels of fair balance apply only to HCP-targeted APS, a weblink to the Terms of Market Authorization (TMA) links the therapeutic use, a violation of the DTCA regulations.

What did we learn from you in 2024?

In October, PAAB sent out our Client Survey to better understand your experience with us — what’s working, what’s not, and where we can grow together.

This year’s survey offered deeper insights into awareness of recent Code and guidance updates, and helped us identify how we can better support your PAAB experience moving forward.

Thank you to everyone who participated. Your feedback is already driving improvements across training, review practices, and communication.

Check out the full Customer Insights Report

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.

Hi @caitlinbyrne

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

Hi @chagali-toney-0

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.