Members of CHCP
Hi there,
The answer is similar to that provided by ALee for your related RWE question. The Health Canada terms and conditions for advertising are applicable to Class B opioids. They do not apply to other products that are classified as controlled substances. The terms and conditions for Class B opioids are applicable to all claims including exclusivity, experience and non-clinical claims.
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.
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.
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.”.
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.
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PAAB
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.
