@Jennifer-Carroll Ah. Thanks for clarifying. I misunderstood that question 466 was in relation to attaching an approved template, and not just for a regular email. Thanks for the 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!

@SKW If independent third party content on COVID-19 is being provided to a patient through a branded patient support program, an assessment of the linkage should be performed to ensure the acceptability of the content within the context of the brand. This remains true even if being sent without the brand logo (i.e. they are being sent the content because they are part of the branded patient support program). PAAB would do an assessment of the linkage to the content which could be done through an opinion file and would be subject to the four day turn around time.

@akar Great question. Note that any of the proposed content would require review under the PAAB code. This is occasionally a point of confusion in the generic space. If the generic product’s TMA refers to the innovator brand as the reference product, the generic manufacturer may convey this fact in the APS. For example, “… generic version of Drug X [the reference product]”. In the unlikely event that the reference product is no longer authorized for sale, this should be conveyed through a cross-reference to the claim above. However, a manufacturer should only discuss the availability status of its own products. For example, it would be unacceptable to comment on a competitor’s drug shortage issues. Any messages relating to switching will require support from the TMA or standard setting organizations.

@lilymcneil These questions may be acceptable if the content, context, and link aligns with the general guidance provided in our prior response. Of course, copy specific guidance would be provided as part of the review process. Questions and responses need to be assessed in the context of the entire piece and with assessment of the references.

Hey @rcolbear Yes, the entirety of the message delivered should meet the standards of code section 1.5E in order to not be subject to PAAB preclearance.

@Jennifer-Carroll said in Linking out to RAMQ website: A link to the formulary site for any province would render the piece subject to review. While a message of “now on formulary” may be considered exempt and the formulary alone is not within the scope of the PAAB code, the linking of the two pieces renders the content subject to the advertising provisions as it creates a link between the brand and a therapeutic message. As per PAAB Q&A 565, the link to RAMQ coverage would be considered a therapeutic link. Hope that helps. Thank you for clarifying Jennifer!

Hey @AnetteCPC Multiple factors can potentially come into play. But the most frequent determinant tends to be whether the video is embedded in the website and is ONLY accessible on the submitted website page, then it can be submitted as part of the same review. If the video can be downloaded, shared or in some way consumed where it is not on the reviewed webpage and complete website, it requires a separate submission. Remember that APS are reviewed as a whole as there may be content on the page or website which creates context for the video, which the video alone may not contain.

@NatBourre Good catch. The hyperlink was an error. We have revised the content now. Thank you.

Hey @palanski and team You are correct. Relative claims may appear as the main message (headline), when they include the absolute values. These should be presented as an integral part of the claim and should NOT be a different colour, style, size etc. All other aspects (quantification and qualification) you would normally include in the claim, still remain applicable.

@Jennifer-Carroll said in There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?: Medical cannabis is a healthcare product. Healthcare professional (HCP) advertising for medical cannabis therefore falls within the scope of the PAAB Code of Advertising Acceptance. Currently, medical cannabis advertising may not contain claims, even when directed to healthcare professionals. Advertising materials that do not contain claims are exempt from preclearance for any product category (excluding opioids). However, specific medical cannabis products that are granted a form of Terms of Market Authorization (TMA) based on evidence relating to particular therapeutic uses will presumably be permitted to make claims in HCP advertising. Of course, those materials would exceed the exemption criteria outlined in the PAAB code and would not be exempt from preclearance. Thanks Jennifer - this is very informative. We will share this with our customers.

Thanks @Jennifer-Carroll!

Hey @akar Correspondences intended to promote the company’s services (e.g. sampling services), would be classified as Corporate messages. When such APS mention or allude to a healthcare product, they require review per section 7.4 of the Code. The subject line, the email body, any attachments, and any hyperlinks would be considered in our review. If you are unsure whether review is required for a specific instance, you could submit an opinion enquiring whether the APS is exempt. You can instruct us within that opinion submission to EITHER inform you of the required revisions to make it exempt, or to inform you of the required changes to make it acceptable. See the document Exemption Requests Policy and Procedure

Hey @AnetteCPC This would not be acceptable as the cookies would be placed on the computer, but they would not be able verify who is using that computer. If an HCP was to sign into a verified site on a shared computer, sign out and leave that computer, the next user would be exposed to advertising without verification that they are an HCP. This would contravene consumer regulations.

Thanks for the question @NatBourre The app itself would be reviewed against the standards of the code. While all functionality of the app should be included in the submission, the manufacturer’s legal department should ensure that all Federal and Provincial requirements pertaining to the collection, usage, storage and distribution of patient data are adhered to.

Hello @SKW In answer to your question, please note that the same email sent individually to several doctors would not be considered a 1:1 message. The message described above could be considered exempt if it meets the limitations of a corporate message with no product mention (e.g. identifying or alluding to a product name, class, category). See code section 1.5E. We strongly urge that the email copy goes through the manufacturer’s internal compliance channels. If there are any doubts that the message is truly corporate and does not allude to products, it can be submitted to PAAB for an opinion (4 day turnaround).

We’d need to assess the methodology through which the data was collected and analyzed through the third party research company. Ultimately, it's possible but unlikely since adherence is quite difficult to measure. It is important to distinguish between adherence and retention. Often when folks say the former, they are actually referring to the latter. PAAB interprets compliance/adherence as the extent to which patients administer the medication as instructed by the HCP. This is in contrast to persistence / retention which PAAB interprets simply as continued dispensing of the prescribed medication. It is inherently difficult to reliably measure patient adherence / compliance. We have yet to receive acceptable third party data that supports comparative adherence claims. However, PAAB regularly considers persistence / retention data from recognized or validated claims-based market data providers. The data may be comparative if it is less than 6 months old. Inferences (like “Drug X demonstrated higher retention rate vs drug Y”) may be made if supported by statistical significance.

@cadrian hey dude

Hey @Helen Section 6.6 was revised and repositioned to 1.5. Alternatively, this may have been a typo in the response letter. Please follow up with your reviewer if section 1.5 does not address the issue. With regards to archived versions of the Code, per PAAB Q&A 717, the PAAB website only contains the most recent version of the code so as to clearly promote current best practices.

@NatBourre You can see the link to the community guidelines in the top right corner of the forum or it will be a link available on all pages of the updated PAAB website.