587
Can you please tell us more regarding gated medical information websites. What would be considered an effective and PAAB compliant gate? Verify each HCP by License #? HCP number pattern (do we need to use specific pattern depending on the type of HCP eg: Nurses, Pharmacists, Physicians. and the province)? Thanks
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View Answer [+]
It’s the same standard as for all your HCP assets. Yes, HCP license works. I’ll warn you that some clients have reported that an HCP number pattern does not work. Inevitably, once they’ve considered all HCP types, just about any combination of numbers will gain entry. Since hearing about this, I’ve recommended against that. You could also have entry into the site managed by a third party that validates the person to be an HCP. Note that the HCP should not be granted temporary access to the site while verification is occurring.
586
If a leading pharmaceutical company provides funds for an article on adult immunization but without having any control on the content of the article, can the disclaimer at the end of the article read "brought to you by a leading pharmaceutical company" or does it have to specifically mention the name of the company that provided the necessary funding.
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View Answer [+]
If the article falls in the scope of the PAAB code, the manufacturer must be identified for transparency (PAAB s7.5). If it is not in the scope of the PAAB code, then it does not fall in PAAB’s jurisdiction.
585
Hello - I understand that data exceeding the duration of the TMA is not acceptable (eg. TMA study A is 1 year in duration, new study B is 2 years in duration). However in a situation where a registration trial is designed to read out to 3 years, and the TMA only contains year 2 data, is it acceptable to include year 3 data in APS? Would this be dependent on the year 3 data being directionally consistent with the year 2 data?
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View Answer [+]
No. The data from the later analysis can only be included in the piece once it is included in the TMA.
584
Can you please explain why a claim of "Guidelines recommend..." can only contain the generic drug name, vs. brand name? Would it make a difference if the Guidelines themselves link generic and brand names?
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View Answer [+]
Because guideline recommendations tend to specify the non-proprietary name. Some have expressed a desire not to be perceived as endorsing a specific brand. It does NOT make a difference if the guideline links the proprietary and non-proprietary names. However, the answer does change if the guideline recommendation itself only cites the brand name.
583
A product receives an updated indication, removing some clinical use restrictions (patient type, duration, etc). Can the old and new indications be presented together in an APS? Can an APS make mention of the lifted clinical use restrictions (if they are now omitted from the TMA)? Thank you.
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View Answer [+]
You can describe the change in TMA in an accurate fashion. This may include a side-by-side presentation of the prior indication copy compared with the current content. Clarity is of the essence when doing so. All provisions in the code apply but you must be cautious not to accord clinical significance to the change (e.g. by attributing a reason to the change, by presenting possible consequences of the change, etc.)
582
Can NBRx data be used to make market share claims, if the same principles governing TRx data were applied? Example: Arbace is the #1 dispensed hypertensive among new patients. If so, would the NBRx data need to be directionally consistent with the TRx data (ie. if Arbace is in fact not the #1 dispensed among ALL patients)?
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No. It is my understanding that NBRx integrates Longitudinal Rx data with Xponent data. We have not accepted Xponent data as the basis for claims.
581
For an efficacy claim, comparing head-to-head results of the study drug vs. the standard treatment, what support is required to justify the claim "significant"?
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View Answer [+]
For “statistically significant” you need a statistically significant p-value or CI. On occasion, multiplicity adjustments are required to control for type I error.
For “clinically significant” you’d need the study to have predefined a threshold difference that is deemed to be “clinically significant”. The message “significant” on it’s own is ambiguous, “statistically” or “clinically” should be added as supported.
580
Hi, My question pertains to the construction of the required "Relevant warnings and precautions" section include in a fair balance section. Specifically, can the incidence of the events, for example "serious adverse events of neoplasm' or "QTc prolongation", have incidence or other clarifying information included in the fair balance section for clarification purposes so a HCP more clearly understands the context of the warnings and precautions?
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View Answer [+]
You may choose to include incidences. Make sure the manner in which they are included is complete, clear, and reflective of the TMA.
579
When a disease is very rare, there is often no published Canadian specific epidemiology or incidence studies. What is PAAB's position on allowing a simple statement that the disease is 'rare'?
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View Answer [+]
Given the nature of the statement, we can consider review papers as support.
578
Hi PAAB: We have a new product in our pipeline that is currently undergoing approval process with Health Canada (pre-NOC). We want to do a targeted campaign to HCPs around disease state, We will not be mentioning any clinical data or clinical options. This online piece will be centered around the disease and very general information regarding disease state. Do we need PAAB approval or ASC approval alone is sufficient?
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View Answer [+]
PAAB approval is required as you’ll be targeting HCPs.
PAAB will review the piece under s7.5 of the PAAB Code of Advertising Acceptance. An important part of our review will be determination of whether the piece alludes to a product. This is important as Promotion of a drug prior to market authorization is not permitted (Section 9(1) of the Act, Section C.08.002 of the Regulations). Note that HCPs have specialized knowledge of the pertinent therapeutic area. It is therefore possible that messaging be deemed not to allude to a product when disseminated to the general public and yet be deemed to allude to a product when targeted to HCPs.
For the consumer tactics, both PAAB and ASC provide an advisory review.
Please see section 2 of the “List of Canadian Advertising Preclearance Agencies” on the Health Canada website for further clarification on preclearance agencies and their roles.
