Great question @jen_antibody Assuming that the email template was submitted to meet the restrictions outlined in the second paragraph under “Dissemination” above, you would not be required to resubmit the template. Yes, you should provide the “attachment name” within it’s submission and convey that the intent is to disseminate through the approved template (efile #). No, you are not required to resubmit the template due to updates to pieces which were previously listed through the template. Let us know if you have any further questions.

@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.

@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.

@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.

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.

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.

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

@cadrian hey dude

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.

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.

Good Morning @rcolbear As per “Chapter 4. Post Approval” in the document “Guidance on Submission Process”, a request for extension can be submitted for assessment. An annotated copy of the product monograph with all changes since the previous TMA should be uploaded. The PAAB will make an assessment to see if the changes to the product monograph impact the piece. It is possible for changes deemed to be “minimal” by the sponsor, to still have a meaningful impact on the piece. Upon PAAB assessment, if the piece is still deemed to meet the requirements of the Code, a maximum 2 month extension can be granted. Note that it is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods. Thank you for the question.

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@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.

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

@Jennifer-Carroll Would you agree that this unique URL provided by the physician to the patient should not contain any keywords that could allow patients to find the website while doing a search for the disease state or the product in question?

Hey @SKW We did some digging and here's what we found: In the last 6 months, there have been approximately 4087 distinct APS submitted for review from 65 manufacturers. Of these, 87 (just over 2%) were submitted directly from 6 manufacturers. Of these, 2 manufacturers did not use an agency at all during that period.

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).

@Jennifer-Carroll Thank you for sharing this information.

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.