Forum

Jennifer Carroll

Q&A 501 is exactly the one we would have pointed to @dmauri . However, the copy "Now authorized" alone is incomplete (authorized how? for what?) it should be restricted to "Authorized for use in..." or "Authorized for sale in ...".

Jennifer Carroll

Happy Monday @Manufacturer @Agency

Change is in the air for PAAB’s Accelerated Review Options (AROs)!

A client favourite, the ARO service has built a strong track record of expediting approval for the types of submissions that fall within its scope. This success has motivated us to explore creative ways to expand its availability, and make it even better.

This expansion is designed to meet industry needs head-on. We’ve listened to your feedback and invested in processes that make this possible.

The following outlines the key changes to the ARO service including a revised fee structure that will take effect December 8th, 2025.

New: ARO availability broadened significantly

Historically, ARO was limited to a narrow slice of submission types. As of December 8, 2025 we are flipping the model: ARO is now available for most submissions, with only a few exceptions.

Note: Previously approved content (appropriately shaded) is not considered new content and would not apply to the new content page limits listed above.

If you'd like your APS assessed for ARO eligibility due to special circumstances (e.g., PAAB has already provided an opinion on the acceptability of a study), please reach out to review@paab.ca for a free assessment

Messenger functionality is now included with every ARO until March 31, 2026 at no cost

We’ve received very positive feedback on the new messenger feature, and early trends show that it effectively contracts time to approval. In advance of our 50th anniversary, we are offering messenger bundled with any ARO review at no additional cost for the end of Q1, 2026.

To activate messenger, either request it within your initial submission form or email review@paab.ca. This applies to both ongoing and new AROs. Please note that only one package of 5 messages is included as part of this offer.

Note: Messenger remains available at cost for standard (non-ARO) submissions.

ARO is now available for DTC submissions

ARO-2 can now be used for direct-to-consumer (DTC) submissions, provided the submission contains fewer than 10 pages of new content. There are no exclusions applicable to ARO-4.

Notable ARO fee changes

• ARO supplemental page fee increase to reflect the more detailed assessments that are now available to ARO:

ARO-7 and ARO-10: $2/page → $4/page
ARO-2 and ARO-4: $4/page → $8/page

• Removal of automatic upgrades for short ARO submissions: Previously, APS with ≤2 pages of new content received a free level upgrade. This policy created tracking and reporting challenges. Broader ARO availability would further accentuate these challenges. As such, automatic upgrades have been retired.

Please reach out below with any questions.
Thank you
PAAB Team

Jennifer Carroll

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.

Jennifer Carroll

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.

Jennifer Carroll

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.

Jennifer Carroll

Hey @kshulist

Branded APS can present mortality/prognosis in general terms in the context of disease burden in an un-emphasized manner when there is no product data for mortality/survival, i.e. it is presented among a broad discussion of burdens including those that they have supporting product data for and there is a prominent disclosure included, indicating what the product has not demonstrated an effect in mortality/survival. Please see our disease burden document for additional information.
This is generally correct. Please see answer to question 1 above.
Yes, section 3 of the disease burden document provides the required references to establish the burden, e.g. authoritative consensus guidelines.

Jennifer Carroll

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

Jennifer Carroll

Hello @Username

Is the product dual schedule or only “ethical”? Is it for the treatment of a schedule A disease?

One would need to consider schedule A and dual scheduling to establish which DTC regs are applicable (and consequently the degree to which they differ from HCP regs). If we assume the product is not dual scheduled and its use is not on schedule A, it is likely that the same imagery and heading can be used. However, there are instances where that is not the case because the HCP looks at the ad from a different vantage point as the general public (I.e. the same message can convey different/additional meaning for the HCP). Also, the HCP piece may contain different content that impacts the context in which the image and heading is interpreted.

One way to make sure the same image can be used is to submit an opinion to PAAB for the DTC along with the HCP piece.

Jennifer Carroll

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

Jennifer Carroll

Good afternoon @Username

As previously noted in the question "Comparative therapeutic claims of schedule 2 products in DTC setting", the term “Schedule 2” is quite broad. Could you please clarify by specifying the federal drug schedule?

With respect to your question about whether there is a “clear regulation that would forbid DTC and HCP from having the same visual or headline,” this depends on how “clear” is interpreted. There is no direct statement in the Food and Drugs Act that explicitly addresses this scenario. However, the principles governing advertising regulations are outlined across several regulatory and guidance documents.

The nature of the claims and visuals would influence how such a case is assessed. Additionally, the idea that materials could be independently reviewed and approved by each “respective agency” may present challenges, as this would assume both agencies are aware of each other’s submissions, which is not always the case.

We would therefore recommend submitting the materials for an opinion to ensure clarity and alignment with the applicable standards.