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There seem to be some inconsistencies within the answers provided in this forum. In Question #313, PAAB replied that the indication does not constitute a 'claim' while in Question #303, PAAB stated that the indication is indeed a 'claim'. Could you please clarify your position. I'd argue that the indication is a claim as it refers to a therapeutic/ clinical effect.
An indication statement is a claim. BUT it does not (in and of itself) impact whether the highest, middle, or lowest level of fair balance is required. A piece with only the indication statement, would qualify for the lowest level fair balance. Please see the guidance document "Guidance on Generating the Three Base Fair Balance Levels" and "Guidance on Base Fair Balance Level Selection and Placement".
I'll assume the question relates to HCP advertising. For any healthcare product (as defined in section 11 of the PAAB code), regardless of its federal schedule, advertising must be contistent with the Terms of Marketing Authorization (TMA). Where the reference for a particular claim is something other than the TMA, the reference must meet all rigors required in the PAAB code (which from an evidentiary perspective are identical for Rx products versus non Rx products). For fair balance requirements relating to OTC products, refer to PAAB code section 2.4.3.
As per section 6.6(ii) of the PAAB code, personal correspondences are exempt from PAAB preclesrance. See Q&A # 308 for more info and some caveats.
This is a forum for Q&A on the general meaning and application of the PAAB Code of Advertising Acceptance and not for reviews. You may submit an opinion request for assessment on whether there is a way to revise the claim so as to render it consistent with the product's Terms of Market Authorization and data. See the fee schedule on the PAAB website and call our admin team if you have any questions.
A piece with only the indication statement, would qualify for the lowest level fair balance. Please see the guidance document "Guidance on Generating the Three Base Fair Balance Levels" and "Guidance on Base Fair Balance Level Selection and Placement".
What are the steps to review and approved a website? Does the content of the site may be revised first as independent, indicating the titles subtitles, main menu, submenu, boutons, etc..? And then once approved texts, we submit the entire site with images of each page and approuved content.
Or should we submit from the first revision the entire website as one ASP needed to be revised with images of the design which will present content that not approuved?
The PAAB cannot review off a live site. Therefore, the submission must clearly/fully describe all electronic functionalities. Generally speaking, if both languages are to be produced, we will review the English copy and layout and then ask for French translation.
The initial submission should include:
If the website is large, split the site into modules (within the same eFile) which fit the system maximum document size of 20 MB. The file name for each module should correspond to the same numbering scheme used in the provided site map.
The layout requirement can generally be addressed by screen shots once the piece is near copy approval.
The following parts of a website are required to be separated into different eFiles:
If a disease state can cause mortality, but products in that class are not indicated to improve survival/ reduce mortality (they are indicated to treat the disease), can mortality be discussed in a disease context if the same piece also discusses therapy options (editorial piece), or in the case of a branded piece a specific product? Would their be a need to completely separate the discussion of mortality in a disease-only piece that would have to be discussed in a separate call from any branded messing or discussion of therapy?
Disease info exceeding the indication may not appear in a product branded piece (even disease content is restricted by the authorized indication). In an unbranded piece, disease content in the context of discussion of product class/category should be within the TMA of at least one of the products within that particular class/category. Such outcomes must be discussed in a manner which is separate & distinct form drug therapy.
The key issue to consider here is whether the linkage between the product materials and the disease materials is appropriate. Your answer is "yes, provided the independently generated disease materials are not modified in any way and they are not overtly off-label
A product monograph (PM) is only one example of a terms of market authorization (TMA). For example, the Product License is another form of TMA used for natural health products and homeopathy products. Data on file (DOF) is generally not an acceptable reference to support claims in HCP advertising. In order for PAAB to approve DOF, there must be clear proof of acceptance of the DOF by Health Canada (e.g. inclusion in the PM). We do not presume that all content within the reference in question are approved by Health Canada merely by virtue of being submitted as part of the NDS. For products having a product monograph, the MOA in advertising should be within the limitations of content presented in the product monograph.
Advertising to HCPs other than that covered in section 6.6 of the PAAB code requires PAAB approval. The PAAB code section 6.6 defines "personal correspondence as" single letters carrying a personal response or message. BUT it goes on to explain that this exemption does not apply to multiple personal letters initiated by the company. It is important to note that this code section only exempts a piece from the process of preclearance. Note that this section of the PAAB code only exempts a piece from PAAB preclearance, it does not necessarily exempt it from the advertising provisions in the Food and Drugs Act. For example, a drug rep sending an email to an HCP about off-label use of his/her product may be found to have contravened the Food and Drugs Act (even though it was only sent to a single person). Use the Health Canada policy document "The Distinction Between Advertising and Other Activities" to determine whether it falls under the advertising provisions. The section on "Unsolicited requests for information" will probably be particularly relevant to your question. Please do not hesitate to submit a written opinion to the PAAB if you'd like our thoughts on the specific activity you have in mind. Please refer to the fee schedule on our website wwww.paab.ca
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
