387
May we:
- Report the results of a patient satisfaction study to doctors?
- Ask doctors' opinions of key results from of that study?
- Then report back to all doctors a summary of responding doctors' aggregate opinions?
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View Answer [+]
In principle, this is possible for satisfaction messages relating to (and limited to) specific product attributes for which surveys (conducted without the sponsor’s influence) can be considered such as taste, packaging, dosage form, and/or ease of administration. Having said that, there are several provisions relating to level of evidence and type of messaging to consider. As this is not the optimal forum for that level of detail, I’ll keep my response “high-level” and I’ll strongly urge you to either submit a formal opinion detailing your proposed methodology and messaging to the PAAB or setting up a consultative meeting with PAAB before going too far (see the fee-schedule on our website).
In short, the document summarizing the results of the study would be reviewed/approved by PAAB. This means that the study methodology must be aligned with the PAAB code as must the messaging within the document outlining the results for distribution to HCPs. Once this process is completed, the HCP survey messaging would be assessed for consistency with the PAAB code (i.e. we will review the questions). Once this stage is done, the messaging relating to the results would be assessed for consistency with the code.
386
I am developing a gated HCP website that requires the HCP to enter his/her license number to gain access to the site. Do you have any recommendation as the where to purchase a list of valid license numbers? Thank you.
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View Answer [+]
As PAAB is an impartial preclearance body, we cannot endorse specific service providers. We cannot even provide lists of such entities (you can imagine we’d get questioned as to why certain entities are listed while others are not). Fortunately, you do have several avenues through which you can procure this information. For example, you may want to contact a communication agency actively involved in the web space (there are several industry directories which can assist you toward that end). I imagine medical publishers and CME providers would also have answers to this question. Sorry I cannot be more specific.
385
Our client would like to produce a Canadian consensus statement in a disease area where there are currently no relevant guidelines. The publication would be peer-reviewed and cover all therapeutic options; we would ensure that any discussion of the sponsor's product was on-label. The intent would then be to distribute reprints through the sales force, and possibly also create an unbranded APS highlighting the availability of the consensus statement (no emphasis on a particular drug). Can you give us any guidance on how we should set up the consensus process and paper to be acceptable for these uses? Assuming the publication is peer-reviewed, would the fact that it has a single sponsor be an issue? Is endorsement by a medical association required or just recommended? Thanks in advance.
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View Answer [+]
For consideration as evidence in HCP advertising, guidelines must be endorsed or recognized by an authoritative medical body. It is not sufficient for the guidelines to be published and peer-reviewed. While some guidelines are published, they may not be endorsed or recognized by an authoritative medical body and therefore may not be reflective of current medical practice (thus falling short of meeting PAAB code section 3.2). Note that the guideline (and the endorsing medical body) should be nationally recognized. We can consider authoritative North American or U.S. guidelines in the absence of Canadian guidelines.
I note that your question relates to unbranded pieces. Clients are often surprised to learn that acceptable guidelines cannot be used to support advertising content which extends beyond a product’s monograph (or all monographs in a class), EVEN IN UNBRANDED PIECES (i.e. PAAB 3.1, 3.2 & 7.5). Please keep this in mind.
384
What type of references are allowed in unbranded materials? I am interested in using studies which are based on patient surveys/questionnaires as well as some review papers (neither of which have a focus on the company's branded product). Would these type of references be allowed or are strictly limited to the same rules as branded communications? Thanks.
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View Answer [+]
The required level of evidence for any given message is based on the message itself rather than whether it will appear in a branded or unbranded piece.
383
We have 2 questions regarding inclusion of treatment guideline statements that address drug place in therapy (our product is sited by non-proprietary name) in HCP-directed APS: 1. a) Can treatment guideline statements be included anywhere among product claims? b) Similarly, can treatment guidelines be included on the other side (back or front) of a page containing product claims? 2) Can treatment guidelines be included on the other side of a page containing the main sections of the Product Monograph of product sited in the guidelines (Dosage, Indications, Warnings and Precautions, Contraindications and Adverse reactions)?
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View Answer [+]
The statement cannot necessarily appear ‘anywhere’. PAAB reviews meaning. Context is an important determinant of meaning . For example, it is important to ensure that additional meanings aren’t attributed by the context in which the statement is placed (e.g. the statement should not be used in a context suggesting that product features promoted in the piece are the cause for the stated ‘place in therapy’ recommendation, the statement should not be used in a context attributing clinical significance to non-clinically significant claims presented in the piece…etc).
In response to your other questions: generally, messages that are presented in a manner which is separate and distinct from other messages in the piece are reviewed in their own context. With this in mind, acceptable guideline statements (based on acceptable guideline sources) could be considered on the other side of a page containing product claims or fair balance. Note that it is possible that copy-specific balance be required to appear in proximity to the statement (this depends on whether that specific statement triggers the need to disclose additional information with the claim).
382
I've had the benefit of reading #84. Is it fair to say that a Rep for Product X who during a call receives an unsolicited request from a physician for a reprint of a journal article, in which the manufacturer had no influence over content, and which contains only "on-label" information, and further provided the Rep does not include any summary of the article, but does discuss the approved benefits of Product X during the call, would not be considered advertising?
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View Answer [+]
This would indeed be considered an advertising activity. The activity clearly relates to the manufacturer’s product and the context in which the activity is unfolding, a promotional (a sales call/visit). This is why you’d want to impose some restrictions including those listed in your question to ensure compliance with legal requirements (e.g. on-label). You’d also want to ensure that the specifics of the activity are aligned with the Rx&D code. However, there is no advertising content to submit to PAAB in your scenario. PAAB code 6.6.i elaborates on the exemption as it relates to materials that have been independently controlled and prepared, with industry involvement limited to purchase and/or sponsorship of the distribution.
381
Hi there, Is the full article needed for the references or is the abstract okay if the content of the reference is there. Thank you, Anne
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View Answer [+]
The full peer-reviewed article is needed. For example, we need to assess the context of the statement within the reference and, where relevant, we need to assess the methodology.
380
Are we allowed to post full product monographs on our corporate website, or do they have be behind a HCP-gate?
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View Answer [+]
Yes. A simple list of unchanged product monographs which are approved by Health Canada may appear in non-promotional contexts on corporate websites. Ensure that you are not linking Rx consumer advertising to these monographs (as that would link product to therapeutic use). Consider Q&A 245 & 359 as they touch on this topic.
379
I just want to know the complaints process for PAAB files.
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View Answer [+]
The PAAB complaint resolution process can be found in section 9 of the PAAB Code of Advertising Acceptance found at www.paab.ca.
378
Creating a website which makes reference on use of botox and latisse. Both are prescribed drugs. Does this create an issue with Health Canada guidelines? We are not advertising the products but reference them as to what they can do for patients as well as the possible side effects.
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View Answer [+]
You appear to be promoting the sale of the product, which is advertising by the definition in the Food & Drugs Act. Therefore, Health Canada guidelines would apply. To help you understand what is advertising by legal definition, please refer to the Health Canada policy document "The Distinction Between Advertising and Other Activities" that is available on their web-site.
