Forum

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better ensure that users are consulting the most current and accurate versions of our documents, minimizing the risk of outdated or misleading interpretations.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

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.

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

Lets start with a quick registration video.

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. If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA. If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”. 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)

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).

Hi PAAB team, I understand that "Now Approved" is not compliant. However, is "Now Authorized" an approvable alternative?