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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
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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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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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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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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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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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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577

Hi - I understand that as per Section 6.6iv, an email informing HCPs about 'updated provincial formulary criteria for Drug X' would be considered PAAB exempt (if there were no linkage to therapeutic or promotional claims). Could you provide clarification on whether including a website link to the full formulary list of a province would still be considered exempt? Note that this formulary list contains criteria specific to Drug X.

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576

We are in the process of developing a tool that will highlight a product's reimbursement program. It would state "reimbursement navigation assistance available for Product X" and would include a tear pad with necessary information to be completed by an HCP. This tear sheet would not be provided to patients, but would be faxed directly to the manufacturer. In addition, this tool would not include any product/promotional claims, only the name of the product would be mentioned. Given that messages limited to name and price are exempt from PAAB review, would "reimbursement navigation" also be considered exempt? If not, is there any way to make this tool exempt?

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575

Our question is related to question no 70 which was: "The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article? Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 and on instructions for use or use limitations8 may be acceptable as side-by-side presentations and in text form.]". PAAB answer: "The PAAB Code (s3.1.1) does not regard "review articles" as high level evidence to support a drug specific claim because they reflect an opinion/ summary from an author rather than actual findings of a primary study. This also applies to non-clinical claims. Our question: Does PAAB regard "Guidelines" (such as CGA guidelines) as high and appropriate level of evidence for a side-by-side comparison of use limitations? Thanks

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574

I intend to submit a non-branded APS into PAAB shortly. One call to action we are considering is a link to a URL that has been ASC approved (but not PAAB approved). We intend to link to not the whole site, but rather a particular section of the site. Would this subject the entire website to PAAB review?

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

To view the PAAB
Code of Advertising Acceptance
click here
Pharmaceutical Advertising
Advisory Board
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Have a great summer and see you in September.