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I'm working on building an app for a pharma client. It's a companion for a drug they market. But I'm concerned that the review section in the App Store will put us at risk of being non-compliant. Do you have any suggestions to help?

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  As the concern is that consumer generated content may contravene the regulations, one option is to deactivate the review section (this may be possible depending on the particular App store in question). Alternatively, you could monitor the reviews and have them corrected or removed if they contravene the regulations. More information on monitoring can be found in the guidance document https://www.paab.ca/resources/Online_Activities.pdf

  Guidance document for Online Activities - paab.ca www.paab.ca PAAB Supplementary Guideline Online Activities 2012-FEB Page 3 of 22 INTRODUCTION The growing popularity of online forums to share information and connect with a virtual

In a DTC Consumer Brochure discussing treatment options for a given disease, can narcotic treatments be included in a balanced list of treatment options? We are assuming a Consumer Brochure is not defined as advertising under the Narcotic Control Regulations s70.

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  You are correct in that a piece meeting all the provisions of the consumer brochure would not be considered advertising (and would therefore not be subject to advertising regulations). I advise caution though. If you inadvertently execute the piece in a manner which happens to render it subject to the advertising regulations, NCR 70 would come into play. I therefore strongly urge you to submit the piece to a preclearance body for a DTCI advisory opinion. Be particularly vigilant about focusing mostly on disease information (as opposed to creating a tool which is mostly about drug therapy) AND ensure that all treatment options (pharmaceutical and non-pharmaceutical) for the specific condition are discussed in a manner which is balanced with respect to risk and benefit. The complete list of provisions can be found in Health Canada’s policy document “The Distinction Between Advertising and Other Activities”. If any competitor would not likely be just as happy to sponsor this piece, you may be threading on dangerous waters.

We would like to do a table comparing non-clinical aspects (indication, route of admin, dosing, monitoring, etc.) of various products indicated for a specific disease. There are more than 10 drugs with this indication, so it will contain a lot of information, all of which will be based on the respective product monographs. It is our intention to give each brand equal prominence (i.e., it will not be specifically branded to one drug). What are the balance requirements for a piece like this? Normally, we understand that dosing warrants high-level balance. However, we can't possibly fit high-level balance for all of the product that will be mentioned in this piece. What do you suggest? Thank you!

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  Please note that dosing messaging in and of itself does not prompt requirements for the highest level fair balance. Dosing messages limited to optimal administration of the product(s) would generally be subject to lowest level fair balance.  However, we note that your question mentions a comparison of indications and monitoring warnings. In HCP advertising, comparison of indications, contraindications, warnings and precautions, drug interactions or overdose would trigger the need for highest level fair balance.  

  The piece would require review to determine the appropriate level of fair balance.

  We’ll need to consider more than simply the type of content in the piece. For example, we’d need to consider whether the piece qualifies for editorial provisions outlined in code section 7.5.  You may consider submitting the piece for an opinion (see the fee schedule on our website).

Dear PAAB, Our Pharmaceutical Company is planning to do a Patient Support Program gated website; we will send this website to PAAB for review. We would like to add links to an independent patient association website that has different resources for patients. If we link to the home page of the patient association, will PAAB need to review the entire website even if we with a disclaimer that they are leaving the company website? Can we link to separate documents (e.g. disease state , treatment options)? In this case does PAAB need to review each document ? Since our website is branded are these going to be reviewed as branded pieces? Thank you.

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  When setting out to link branded and unbranded content, all content becomes branded. It is possible to link to third party independently created website from a standard setting organization (i.e. reputable patient associations). We suggest that the link be made to the homepage, in which case the PAAB would assess the link as part of our review of the Patient Support Program submission to ensure that the linkage is not off-label. However, if the manufacturer were to link the submission to specific sections of the independent site (instead of the simply linking to the home page), the PAAB would need to perform a complete review of those sections as one or more separate submissions. Those reviews would be performed under a product branded lens.

Are there any limitations for using Phase II studies as support for therapeutic claims, apart from disclosing the Phase II nature?

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  Whether you are using a Phase II or a Phase III study to support therapeutic claims in advertising, the same standards apply:

  • Clinical or therapeutic claims must be based on published, peer-reviewed, controlled and well-designed studies with clinical and statistical significance clearly indicated. The study (and the claim you wish to base on the study) must meet all relevant criteria listed in the PAAB code and the PAAB guidances.

  and

  • The study must be consistent with and within the limitations of the TMA

  The PAAB code does not specifically differentiate between phase II and phase III studies. Having said, keep in mind that phase III studies are much more likely to meet all the criteria listed in the PAAB code and PAAB guidances than phase II studies. If unsure of the acceptability of a study as the evidentiary basis for a particular claim, consider submitting a opinion request (see the fee schedule on our website).

I understand that for international conferences held in Canada the following conditions need to be meet for being exempt for PAAB review according to (Health Canada policy document “The Distinction Between Advertising and Other Activities) I. the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions, II. the material must emanate from the parent company of the manufacturer, III. the material must only be for use within the confines of the conference, and IV. the material is prominently identified as not being authorized for sale in Canada. The question I have is for the use of material that is non-branded and no product specific that makes reference to a therapy area/class for which several products are approved in Canada for sale by the local subsidiary. Would this non-branded, no-product specific material (banner), that talks about a therapy area/class would it be considered PAAB exempt for use at an international conference?

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  Are all 4 criteria you listed met? For example, I am unsure from your question whether the material emanates from the non-Canadian parent company. If all 4 criteria are indeed met, the material is exempt from Canadian advertising regulations and, consequently, outside of the scope of the PAAB code.  This is true regardless of whether or not the products are approved for use in Canada (i.e. available from the corresponding Canadian subsidiary).  This is also true regardless of whether the material is product branded or not.

  If, on the other hand, the material emanates from a Canadian manufacturer, the material would be subject to PAAB preclearance even if it is not product-branded.  After all, the material in question would be used in Canada, it would emanate from the Canadian manufacturer, and it would feature one or more products/classes in the context of a therapeutic area in which the manufacturer has a vested interest.  The material would therefore be subject to Canadian advertising regulations (including the PAAB code provisions).  It is easy to come to the flawed conclusion that materials that are not product-branded are not advertising.  Don’t fall into that trap.  Advertising is defined in the Food and Drugs Act as "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device".  The definition matters because Canadian drug advertising is subject to Canadian drug advertising regulations.  For example, the provisions in the PAAB code apply to drug advertising directed to HCPs.  Whether materials emphasize/favor a specific brand does not in and of itself determine whether the materials are subject to advertising regulations.  In fact, the PAAB code has provisions that relate to unbranded editorial advertising such as section 7.5 (i.e. the PAAB code is not limited to product-branded advertising).  We’d need to review the piece to determine whether it is indeed editorial advertising or product-branded advertising but this does not impact whether review is actually required (it only impacts the nature of the review).  

If I have two clinical trials in slightly different patient populations, is it acceptable to present data from only one of the trials in an APS?  Both populations fall under the same indication.

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  The most relevant principles here appear to be that data presentations in advertising must be consistent with the TMA (s3.1), must not be overly-selective (s5.12), and must consider all relevant data (s. 5.5.i).

  Assuming both studies can be used in drug advertising (e.g. on-label, high-quality, etc.), you’d need to consider whether presenting data from only one study would be overly-selective (or misleading in some other way).  This could potentially depend on many factors. For example, the degree of similarity between the populations, the extent to which the outcome in question differs between both studies, the degree of consistency with outcomes in the TMA, …etc.

  If an HCP who modifies her behaviour/attitude based on something learned from an APS about study A is likely to feel misled after later learning about study B, the APS likely requires inclusion of study B so as not to be overly-selective.

Hi Patrick, I was wondering, after PAAB approves copy. Is it forbidden to make minor typography changes? I.e. spelling mistakes, punctuation, periods. As long the same message is there is that still considered an unsolicited change?

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  The document ‘Guidance on Submission Process’ on the PAAB website sets the boundaries for which post-approval changes made to an APS can be processed as “FYI” (versus changes that require reviewer assessment and approval in a new file).  The following can be processed as FYI:

  • corporate logo, trademark changes
  • French language grammar correction which does not alter the claim
  • directly proportional resize of APS that results in NO layout/flow/content/functionality changes.

  All other post approval changes to previously approved APS including any copy or layout changes are subject to further review and should be submitted in the form on a new eFile. While PAAB will consider it acceptable to correct spelling mistakes, they should still be submitted as an FYI to ensure that the most accurately copy is kept on file. It is possible to change the meaning of copy by changing the placement or type of punctuation, making it difficult to make a blanket statement of “all typography changes are acceptable”.  If you are uncertain if your grammatical change is acceptable as an FYI, please contact admin for further clarification.

Our company has an unbranded disease-focused app in the Apple/Google stores. As legally required, the manufacturers name must be disclosed in these stores. Can we make mention of this app in a separate DTCi Help-Seeking campaign (that itself does not mention the sponsor)? The campaign would not focus on the app, but mention it as one of many additional resources.

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  The Health Canada document “Distinction Between Advertising and Other Activities” states that materials that fall in the category “Help Seeking Announcements” must not include the manufacturer’s name. PAAB interprets that to mean that the piece must not identify the manufacturer by any means.  Providing a direct link to a corporate branded asset would identify the manufacturer.

  In your specific case, I have no way of knowing whether your piece is indeed a help-seeking announcement (for which this linkage issue would apply). Nonetheless, a simple solution exists if that is the case. You could direct the public to the app using corporate advertising as opposed to a help-seeking message.

  E.g. Company X created an app with features A, B, and C for patients with condition Y. This app can be downloaded at the app store: Click here. We are committed to helping you.

  You’ll note that I left out content relating to how a patient might know if he/she is afflicted with condition Y (e.g. symptoms, history…). I focused instead on the service that this company is providing to individuals afflicted with the condition through provision of the app. 

  I should also point out that there is an important exception to the linkage issue I discussed above.  A help seeking announcement may link to a document meeting all requirements of a consumer brochure. This is true even though the consumer brochure will identify the manufacturer. In that instance, the reader would learn about the identity of the manufacturer in the same context that he/she is exposed to presentation of the treatment options (drug and non-drug) and their respective risks and benefits discussed in an objective manner.    

We have a product indicated for the treatment of 'drug-resistant Condition-X'. Since this disease inherently links to drug therapy, I do not see how we can produce PAAB-exempt disease education materials. Does this seem like a fundamental limitation of the Code (6.6vii)? Could we produce exempt materials describing 'resistant' or 'refractory' Condition-X instead?

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  The interpretation that a piece describing a ‘resistant’ or ‘refractory’ condition is subject to PAAB review is correct. It would not be possible to create a disease information piece for this condition without alluding to drug therapy. The rationale for this however is more related to the PAAB scope of review then any specific preclearance exemption criteria.

  PAAB provides a preclearance review service related to promotional activities for healthcare products. Materials which are restricted to disease information (i.e. they do not allude to treatment in anyway) do not fall within the PAAB scope of review. Statements describing a condition as ‘resistant’ or ‘refractory’ suggest a prior treatment failure and as such would fall within the PAAB scope of review (as the disease material would not be required had treatment not occurred). This is necessary to ensure that discussion of drug therapy meets the PAAB code requirements.