Hey @NatBourre As per Q&A 529, “Study findings which are not presented in the TMA (whether because that study is not in the TMA or because the portion of the study in question is not in the TMA) can be considered in drug advertising provided the study meets all provisions in the PAAB code and guidances”. Some elements to consider are that the outcome is consistent with the indication and outcomes presented within the TMA and that the reference is a published and peer-reviewed study which is blinded, randomized, controlled and designed a priori to measure the outcomes. Components of the study which would be considered outside of the limitations of the indication would not be considered.

Good morning @Username, sorry for missing this question – let's see if we can still help you with this It's important to not confuse the directions for patient pieces and HCP detail aids. The situation you are describing in paragraph two appears to be mixing the directions for patient and HCP. Patient material should be non-promotional information. In the situation where there is a combination of multiple NOC and/or NOC/c’s which cross the same therapeutic category, the copy should be clearly limited to the NOC population. If the copy is broad and could encompass the NOC/c to some degree, the NOC/c would be required to be presented in the piece. For the question in paragraph three, “at first mention of the therapeutic category” refers to pieces where there may be NOC and NOC/c in different therapeutic categories. For example NOC for RA and NOC/c for UC. If the piece doesn’t mention UC until page 3, the NOC/c disclosure is not required until that page as that is first mention. In a situation where you have one NOC and one NOC/c within the same therapeutic area and presented together upfront, the first presented option within the document Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc should be followed. For example, the complete boxed NOC/c copy from the cover should be presented.

Hey @Don-Bolton That is correct. At a minimum, all elements of the logo must be legible. Additionally, we did not impose a maximum size limit. We understand that some advertisers may wish to use logo prominence as a way to highlight and differentiate their APS, which have undergone preclearance, from sources of information which have not. This may become increasingly valuable as, at the beginning of October, we will be embarking on a 3-year omni channel HCP marketing campaign aimed to ensure that HCPs (and eventually patients) recognize what the PAAB logo signifies.

Hey @tmcd Yes, you can do this. Please see the last response posted on September 1st under the document PAAB Logo Style Guide. As a courtesy, remember that you can set the intended date of use of the piece to be October 1st. This would not only avoid the issue identified above, but would also give you additional time at the end of the approval period.

Hey @AmandaM , interesting case. It’s difficult to imagine a situation where some aspect of the piece is not going to change. For example, the addition of a name to the document (PDF) would be considered new copy. Similarly, copy prompting the delegate to download or access the PDF (via text or image) would change the copy and render point 1 of the Clarification regarding digitization of APS document not met. Another consideration is the manner in which a delegate accesses the content (PDF). For this, please consider the guidance provided in the Advisory on Disclosure of APS Placement Details which reflects the understanding that content reviewed will have run-of-site/random placement within publications or platforms. If the positioning of an APS is not random, and is instead by design, this must be disclosed to PAAB when the APS is submitted for review. In summary, there are many aspects about the piece and access of the piece within a virtual conference which would create some form of context which goes beyond the direct digitization of a print piece to a PDF version. If there are additional aspects not considered above, specific to your case, you can always use the PAAB opinion services for a more thorough review of your use case.

Hey @NatBourre, A balanced presentation of the treatment guidelines can be considered in an non-branded APS when there are multiple treatment options either within one category or across multiple categories. The distinction is that there must be more than one drug product featured. If only one drug product is featured, regardless of other branding elements, or even direct mention of the product, the piece would be branded.

Hello @palanski As a general rule of thumb, if the update has impact on the piece it should be submitted as a new file new fee. An example of an update that would not impact the piece would be reformatting the TMA headlines or grammatical revisions. Another example would be an update to add a new dose format, with no other updates to the TMA and all other information about the original format remains unchanged. If the piece speaks only to the original dosing format, this update to the TMA is unlikely to prompt a new file. Every case is different as there can be both small (note that even small changes may alter the context of existing claims) and large changes to TMAs, making it hard to define a threshold. All TMA changes would need to be considered in the review of the overall APS. Remember that significant unsolicited changes during an ongoing review are subject to a new review so if the revision to the TMA impacts the piece in anyway, it is within the Reviewer’s right to send the file back for a new review.

Hey @SKW As Patrick Massad is now the Commissioner, you should reach out to Yin Man, Senior Reviewer of Preclearance, to request opinion meetings. We have updated the website accordingly. Additionally, you are not restricted to the number of attendees from the Pharma company. Thank you for the questions.

Thanks for identifying that @palanski ! We've adjusted the privileges so that you should now have access.

Hey @akar The Distinction Between Advertising and Other Activities, the Health Canada document which outlines what constitutes advertising, asks a series of questions to determine the nature of the activity. The author and distributor being a medical director in and of itself, does not, in and of itself, necessarily render a piece exempt from Federal advertising regulations, the PAAB Code, or PAAB preclearance. Please see PAAB Q&A 403. While this question asks about “slides”, the same would apply to letters, emails, etc. PAAB Q&A 750 also walks through a similar set of questions to ask about the activity. A letter stating only that the sponsor’s product is available would be exempt from preclearance regardless of the source within the company. But it should be noted that certain industry association Codes do not permit such promotional materials to be signed by Medical/Scientific personnel. Similarly, a letter only indicating that the sponsor’s product is not available would also be exempt. However, in my experience, when such a letter is signed-off by medical/scientific personnel, it’s because the letter goes beyond that simple message (e.g., why the shortage exists, when the shortage is expected to be resolved, what is being done to mitigate the shortage, what prescribers can consider in the meantime, or so on). Anything on this matter beyond the fact that the product is available or unavailable would require preclearance. If you are unsure if the activity would be considered advertising, and if that advertising requires review, please submit a request for a written opinion (see fee schedule on the PAAB website).

Hey @Sil Evidence not presented in the TMA can be considered in pieces when it is consistent with the TMA and supported by statistically significant, high quality data of predefined study endpoints from a published and peer-reviewed randomized control trial (s.5.9). You have correctly identified some key features we look for (i.e. same indication, consistency with outcome type) along with other things such as comparable dosage strengths or blinding. A key document on the PAAB website which can further assist you in assessing the potential acceptability of the study and claims you wish to make the Marketing benefit claims: what are they and what level of support do they require document. You may also want to check out Subjective versus Objective Endpoints and Guidance on Non-inferiority Trials which speak to consistency with the TMA.

@SKW , The PAAB does not require a PO. We currently accept EFT or cheque. We do not accept credit cards. For additional information you may find helpful, please see https://www.paab.ca/about-review-fees.htm.

Hello @Username If the piece is truly DTCi, than yes, it would be acceptable to have mention of controlled substances. As the risks are higher with controlled substances, it is highly important to ensure that the piece truly meets the DTCi regulations and is not advertising.

Thank you for your quick response!

@Jennifer-Carroll I've solicited feedback from ANTIBODY's Creative Director, Melisa Barrilli, who had the following thoughts to offer on the bilingual logo: Although we rarely use bilingual logos, they do come in handy. Glad a version was created! The bilingual logo seems to have optimized the space and flows well. Legibility seems excellent for the PAAB/CCPP words. It will be interesting to see how all versions look when applied at their minimum recommended size—there's considerable size variation with the smaller type, so "Reviewed by" may become illegible if used too small. Hope this is useful!

Thanks @Jennifer-Carroll!