Ask PAAB

Hi Patrick, Can a company position its brand (from both a creative and messaging standpoint) on secondary outcomes in its PM? If not, then what code number does this contravene?

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  There are a multitude of statistical and qualitative reasons to generally tread lightly with secondary endpoints. Nonetheless, it is sometimes possible for a secondary endpoint to be emphasized as the key creative in an APS depending on factors relating to the study, the particular endpoint, and the TMA.  It is not possible to list all potential scenarios in which this is acceptable and unacceptable. Seeking a written opinion from PAAB (see the fee schedule on our website) is likely a good starting point when attempting this to ensure that you are walking down a productive path. 

  Some reasons I've encountered over the past few months for which it has not been acceptable to focus on the secondary endpoint from the PM include (PAAB s3):

  ·       The secondary endpoint was only accepted in the context of the primary endpoint (e.g. for clarity, to avoid over-selectivity, or because the primary endpoint was directionally different)

  ·       Emphasis on this particular secondary endpoint (rather to some other secondary endpoint) was overly-selective

  ·       The endpoint extends beyond the indication

  ·       the study is located somewhere in the PM other than the clinical trial section of the PM (e.g. in the pharmacology section of the PM)

  ·       The endpoint is particularly sensitive to type I error and this wasn’t controlled in some way

  ·       There is also an important limitation in the TMA relating to this particular endpoint

  ·       There is no statistical analysis done with this endpoint

   

We are creating a website for HCPs using Responsive Web Design, in which one set of content (text, images etc.) will automatically be populated into different layout placements based on the size and configuration of the screen on an HCPs device (table, smartphone, laptop etc.).

We would like to submit only 2 breakpoints for review (desktop & smartphone), because the tablet version will either follow the desktop size/dimensions - or the mobile, depending on the orientation of the screen (vertical or landscape).

Would providing layouts, copy and wireframes for the 2 breakpoints satisfy PAAB submission requirements?

Will you also require screenshots of the tablet version?

Will the different breakpoints require separate submissions? Or will they be reviewed separately but as a series fee?

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  All APS versions created through selection of different breakpoints will require separate review. One file will be assigned a full fee while the related files may be eligible for series fees.

  Why is separate review required? Changing breakpoints impacts positioning of APS elements such as the claim copy, disclaimers, and visuals. Positioning can impact context and emphasis.

  Note that where transfer between mobile and tablet is a direct scaling, with no positioning changes or proportional variation, written confirmation of this and the screen shots can be submitted within the same file (i.e. without incurring an additional fee).

Does PAAB have any specific regulations around infographics? It outlines study results.

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  We have no regulations specific to infographics in particular. Infographics are reviewed using the code provisions as APS messages packaged in any other format.

Hello PAAB, The approval on one of our APS's is going to expire and we would like to continue using this APS. What is the process to renew the PAAB approval? Do we need to resubmit everything for review even if nothing in the APS has changed? Thanks 

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  Renewals are treated as new efile submissions.  On the submissions page, please check off “renewal” and provide the previous efile number.  Your cover letter should confirm that the piece is a straight renewal without change.  We will need a clean English and French copydeck as well as the layout.  The references are not necessary for a straight renewal, but all submissions require the current TMA and supporting approval letter from Health Canada.  If the TMA has been updated since the APS was last approved, please include an annotated version showing all changes.  The Reviewer will want to verify that the updates do not affect the APS.  Note that the intended date of use should reflect the previous file’s expiry.  Turnaround time for first response is the normal 10 business days.

If the URL for a PAAB approved HCP portal (which contains gated product information - PAAB approved) is included on the back of a sales representative’s business card, does the business card now require PAAB approval?

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  Provided there is no additional information about the portal or about a product, there are no other resources provided, and the URL does not include a claim, PAAB review is not required. But even in such cases, it is important that the manufacturer pauses to consider whether this creates any linkages which violate the advertising regulations. For example, a business card identifying the sales rep as the specialist for drug X while also containing a URL for an unbranded website containing off-label disease information would link product to off-label information thus contravening section 3.1 of the PAAB code. Some manufacturers have elected to submit a business card template for a written opinion (no PAAB logo required) when adding URLs or other information on business cards. If you are unsure, feel free to employ our opinion service. See the fee schedule on our website.

We have a slide deck that is being presented to HCPs by members of our medical team.  This deck is PAAB approved.  We have a few questions.  Can we record the session and place it on our HCP gated portal for other HCP's to benefit from? Does the recording require PAAB approval?  In the post-production of the video, can we add chapters to the video so if physicians wanted to watch the video in segments, they can?  Thank you.

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  Yes. It is possible to place PAAB approved slides on a PAAB approved HCP portal. We will need to assess that the linkages created in so doing would not contravene the regulations.

  The recording would include audio in addition to the approved slides. The recording would therefore also require review. You have the option of having speaker notes approved within the same file as the slides provided that the notes are included as part of the original submission. It is possible that the speaker will deviate from the notes in the recording. Should that occur, the recording should be submitted for review.

  Yes, the presentation can be broken down into chapters. The submission for the recording should clearly identify where the chapter breaks occur and any added content (e.g. the titles of the chapters).

Is it within regulation for a pharmaceutical company to disseminate information through patient groups (as opposed to through a health care provider).

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  Yes provided the patient information is non-promotional and consistent with Part III of the PM (as we’ll ensure during the PAAB review). The operative word is 'patients' (i.e. individuals who have been prescribed the medication). Keep in mind that the distribution of manufacturer sponsored patient information for prescription drugs to a broader audience (whether by manufacturer or on behalf of the manufacturer) would appear to contravene C.01.044 of the Food and Drug Regulations as these materials likely exceed the restriction to name, price, and quantity. Particularly when systematic distribution is motivated by a contractual arrangement between the manufacturer and the patient group rather than the result of medical decisions made by HCPs as they perform their professional activities in the best interest of their patients.

If our company has sponsored a newsletter for a healthcare professional group (which official represents their professional specialty) that discusses updates to their independent website (password protected for members and sponsored by us as well)  and the sales force is going to distribute this newsletter proactively, does it fall under PAAB's scope for review due to frequency of distribution/availability and sponsorship combination.  
The website touches on best practices for a disease area including treatment so the newsletter will touch on updates to any of this and do mention our product.  The company does not have any ability to alter content if there is a comment from PAAB.  We would appreciate clarification as we were still not clear after working through the decision tool on the PAAB website (which is awesome by the way).  We are running into similar issues with a disease and treatment video for patients produced by the same group (sponsored by us) which the sales force would also like to distribute broadly healthcare professionals as a DVD and show on their i-pad. (Again, no ability to change content). The two scenarios (newsletter and video) have similar components.  Thank you so much for your guidance on this.

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  Generally, materials discussing drug therapy which that exist due to manufacturer (including materials generated through unrestricted grants) require PAAB review if distributed through the sales force. For a more specific response, please submit the particulars as a written opinion (see the fee schedule on our website).

Are accredited programs exempt from PAAB review?

Would an objective slide deck prepared and approved by the medical department of the company for the sole use by MSLs in their 1:1 interactions with HCPs be considered PAAB exempt?

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  Not necessarily. See Q&A# 360 & 403.