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ensure that users are consulting the most current and accurate versions of our documents, minimizing the risk of outdated or misleading interpretations.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

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 @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)

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 @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.