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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.
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.)
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)?
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.
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"?
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.
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?
You may choose to include incidences. Make sure the manner in which they are included is complete, clear, and reflective of the TMA.
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'?
Given the nature of the statement, we can consider review papers as support.
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?
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.
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.
PAAB code section 6.6.ii states “A message comprised only of the words “now on provincial formulary” (or equivalent) in a manner which is not linked to a therapeutic message in any way”. In addition, the PAAB advisory document “Provincial Formulary Coverage Statements” further states “APS comprised only of “Drug X: Now on OBD formulary” not linked in any way to additional product messages or disease/corporate messages”. As such, a direct link to the coverage criteria for drug X would require review.
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?
A message of “navigation assistance” or “reimbursement navigation” is a service message. The service message would require review in the context of the piece and the brand. This piece would not be considered exempt.
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
The Review Tips and Cases document “Marketing benefit claims: What are they and what level of support do they require” states that pharmacokinetic and dynamic claims should not be linked to clinical claims and should be supported by the TMA. It also states that consensus guidelines should be used for place in therapy claims. Furthermore, code section 5.10.2 states that side-by-side limitation of use presentations may be acceptable when referenced to the respective Product Monographs. The PAAB does not review guidelines as support for side-by-side comparison of product use limitations (e.g. indications, contraindications, warnings, precautions…).
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?
The following answer assumes that BOTH the piece submitted to PAAB and the consumer website are non-branded. PAAB review of the submitted APS includes assessment of the acceptability of the context created by all links to and from the piece. The URL mentioned in your question should be provided as part of the initial submission for the PAABed APS. We would need to assess the appropriateness of the link to that website. If there is no issue linking the PAABed piece to the consumer website in principle, then the PAAB will assess the appropriateness of the link to the particular page within the consumer website which you desired to have as your linkage destination page. Generally, the entire website would not require re-review as it had already undergone review to ensure it meets the requirements for Direct to Consumer Information. The term “generally” was used as there are several potential wrinkles that cannot all be listed in response to a general question. For example, the answer changes if the website was geared to HCPs (even though it might still fall within the restrictions inherent to the consumer audience).
Keep in mind that the regulations governing materials targeted to each of the three regulated audiences differ.
Patrick Massad
Deputy Commissioner
Pharmaceutical Advertising
