Forum

It’s Friday @Agency @Manufacturer and PAAB wants to send you into the weekend with some exciting news: The NEW Creative Imagery in Advertising Advisory is NOW live! After months of insightful and collaborative discussions, we’re excited to finally announce PAAB’s new advisory on the use of creative imagery in pharmaceutical advertising. Industry has asked for clarity, and we hope this document provides that clarity you’ve been waiting for, or at the very least, provides a stronger framework to evaluate creative ideas with your teams. Note that this is not the finish line. This is a starting point to continue to grow and evolve with the ever-changing landscape, to meet the needs of healthcare professionals and patients. We’d like to extend our gratitude to all the industry members of the Creative Committee who took time to share challenges, discuss the advertising landscape, listen to the regulatory concerns and work collaboratively with PAAB to refine the creative imagery discussion. Special thanks to Mike Spelay (bMod), Andy Leeson (Wellworth and Best), and Konstantine Polanski (Point05 Health), for driving the revisions from the first draft document and creating meaningful examples. Thank you to the bMod team for generating creatives to help capture the principles outlined throughout the document. We look forward to implementing these new approaches with you and continuing the conversations.

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.

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.

Good Afternoon @Manufacturer and @Agency It's crazy to say but we're now just past halfway through 2025! The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q2. See the Tag report here and the CEI report here. The Forum Quarterly Review for Q2 has also been posted here. If there's more you'd like to know in Q3, let us know in the comments below. Have a wonderful rest of the summer. Thank you PAAB

Lets start with a quick registration video.

Thank you so much for your response!

Hey @dmauri Great question. As long as the study publication does not contain information suggesting dosing practices inconsistent with Canadian labelling, the manufacturer’s Medical/Regulatory Affairs department can confirm that the dosing in the jurisdiction where the study was conducted is the same as it is in Canada. When it comes to “SoC”, per 1.7 of the Guidance on Real-World Evidence/Data, remember that pooled comparisons are not acceptable which would render the second half of the question moot. However, if you are referring to SoC in a single-arm study (per Advisory: RWE Single-Arm Studies of Previously Treated Patients), we would look to ensure that the overwhelming majority of patients were on a product available in Canada/indicated in the same population in Canada. Regarding "SoC", please note the guidance's remarks on representing the marketplace versus exclusions by design. An opinion can be a great mechanism to get specific guidance on an individual study as it allows for assessment of the study design, therapeutic area, and indicated product(s).

Thank @Jennifer-Carroll , I will look into that and follow up if necessary. Hopefully a more simple question, can non-clinical characteristics of two schedule 2 products be compared in the DTC setting? E.g., Store Product X under conditions A, Store Product Y under conditions B?