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Jennifer Carroll

Hi there,

While standard setting organizations (i.e. reputable patient associations) may be used to support information in Patient Information APS as noted in Code section 6, acknowledgement from a standard-setting organization is not sufficient as endorsement for guidelines as they are not considered a recognized, Canadian, authoritative, medical body. However, PAAB will consider recognized, authoritative US consensus guidelines (when deemed acceptable), in the absence of Canadian guidelines, without need for endorsement from a recognized, authoritative Canadian medical body. Please refer to the PAAB document “What constitutes current medical opinion?” for further details.

Jennifer Carroll

Hi there,

Our regrets for the delay in responding.

The answer to the above original question was provided in general terms based on PAAB code section 3.1.1 which states “…pooled data…are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable”. Even when the original trials are in the TMA, this does not confer acceptance for their pooled analysis in advertising. Q762 provided the general PAAB position as well but expanded to provide the narrow scope where PAAB has considered pooled data which is dependent on a multitude of factors. Q762 provided the starting point for consideration. As there are varying and specific factors that determine the acceptability of a pre-planned pooled analysis, it is beyond the scope of this forum to address. If there is a pre-planned pooled analysis where the study designs are identical or nearly identical, then we suggest consideration of our opinion service to determine if it may be acceptable for use in advertising.

Jennifer Carroll

Hi @QnC

The original question on why can't patient-directed APS for prescription/controlled/targeted drugs be promotional was intended to be addressed in PF Q&A 352 where it was noted that PAAB code section 6 applied to patient directed information and its rationale. The HC Distinction document does not cover patient information, i.e. information to individuals that have already been prescribed the drug. PAAB s6 is applicable to patient information and indicates that “Company controlled or prepared branded patient information is information that contains non-promotional material…All health product information must be consistent with the Terms of Market Authorization (TMA), and should not contain promotional claims.”.

Jennifer Carroll

Good Morning @Manufacturer and @Agency

The PAAB Quarterly Tag and CEI Reports for 2025 have been updated to contain data for Q4. See the Tag report here and the CEI report here.

This year is PAAB's 50th Anniversary! Stay tuned for treats throughout the year to celebrate this milestone.

We're starting the celebration with:

Client Messenger Service - Free with all ARO in Q1 to celebrate PAAB's 50th Anniversary Learn more here.

Have a great weekend
PAAB

Jennifer Carroll

Hey @Username

No. Real or fictitious, a manufacturer should not be promoting patient treatment flows that are not reflective of guideline recommendations as per Code section 3.2.

Jennifer Carroll

Happy New Year @Manufacturer and @Agency

This year is PAAB's 50th Anniversary! Stay tuned for treats throughout the year to celebrate this milestone. We're starting with:

ARO expansion + Client Messenger Service - Free with all ARO in Q1 to celebrate PAAB's 50th Anniversary Learn more here.

The 2025 PAAB Q4 Forum Quarterly Review is now live!

Some of the things that you might want to check out:

AI Assisted Submission Process - Call for volunteers
Attention Icon Update
Expansion for Rare Diseases
Creative Imagery Document Posted
Protecting the Integrity of PAAB Resources

Coming in 2026: New service offerings, anonymous advertising reporting system and more...

As always, thoughts and feedback are welcome below .
Thank you
PAAB

Jennifer Carroll

Hello @dmauri

Yes, a fair balance sticker that replaces only the outdated fair balance with the updated version may be considered as a potential solution. The sticker must be limited to covering the existing fair balance only.
Please note that if the sticker alters the original piece beyond the fair balance (e.g., obscures or impacts other copy or design elements), the material would be considered altered and would require re-PAAB review. This assessment can be made as part of the eFile submission for the sticker and would be communicated to the client at that time.

Jennifer Carroll

Hey @QnC

Please see Q&A 352

Jennifer Carroll

Hello @ebailey

A search of the term "company" on the forum will return Q&A 744 which should answer the above question.

Jennifer Carroll

Hello @Maha-Dogar

Thanks for your question. Please note that this topic has been addressed previously. Searching “secondary endpoints” in the forum should provide the relevant guidance. Note that the response applies regardless of whether or not the study appears in the TMA.

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