Good morning @medwriter

If the context and audience are unchanged, addition of another publication would not prompt an updated submission. "Context" includes no change in targeting or placement (i.e. remains run-of-site) within the new journal and no linkages which were not presented in the initial submission. If unsure, PAAB can provide an opinion (which can proceed to full review if it is determined to be required).

Hey @afpjjim

The principle to consider is in the “Dissemination” section of the document referenced. The copy reads “If the intent is for the email template to be used across many brands (and therefore not contain fair balance), the document naming convention should not trigger the addition of fair balance. This means that it should not contain claims or copy that links the brand to therapeutic use.” If the brand name appears in the piece and there is a study name, this would create that link (see Attachment of clinical reprints in an RTE). During the submission process, you would define the naming convention as “Study acronym_study_safety_data” and convey that studies across multiple brands could be attached in the same email. The reviewer would assess if indication and fair balance are required.

Hey @NatBourre

When images are presented they must be aligned with the indication. If they present an outcome, data to support this effect must be presented within the APS. A letter from medical/regulatory should be provided to confirm that the demonstrated effect in the image is aligned with/representative of the effect demonstrated in the trial (i.e. the average not the best-case scenario).

It would not be acceptable to use the same images in both branded and unbranded advertising as when you link branded and unbranded, everything becomes branded. The images and their presentation in the unbranded pieces would have to be different.

Hi @theodora32

The provisions of pre-printed prescriptions pads are not addressed specifically in the PAAB Code. As a company-sponsored service oriented vehicle, PAAB will review the content of submissions with a prescription pad to assess its consistency with the TMA. However, it is the sponsor’s responsibility (e.g. medical/regulatory or legal departments) to do their due diligence to ensure that this activity does not contravene the regulations and codes of the respective federal/provincial regulatory bodies, health professional governing bodies and industry associations.

Hi @natbourre

There is the ability to link to an unbranded survey questionnaire. However, as it is linked to a branded patient APS, the questionnaire would be subject to the PAAB code. As a reminder, linking unbranded to branded renders everything branded, so please be mindful that unbranded materials should not contain content which would not be accepted in a branded context. In addition, depending on the questions and if the answers/results are not intended for internal use only, the subsequent distribution of the results to patients or HCPs may be subject to advertising regulations as well.

Hi @maryssa

From the description in the question, the ads are visible to the general public but they are designed for HCPs. As such, the primary audience are HCPs and the general public is the secondary audience. Consequently, the provisions of the PAAB Code apply, including the need for PAAB Preclearance. Because of the secondary audience, our assessment would also include the need to adhere to federal regulations pertaining to consumer advertising. Please ensure the submission letter conveys that the banner ad will be placed in pre-gate environments.

Hi @natbourre

Please see Q&A 214. For anything discussing disease burdens, please also see our recent guidance document Guidance on the Presentation of Burdens of Disease in Advertising, specifically section 5.3.

Hey @laraholmes

Assuming that all aspects of the code are met (prominence and clarity of messaging, balanced, complete, non-promotional to patients, etc.), this may be possible. Given the variety of factors that would need to be considered for assessment, including the size/dimensions of the piece, we suggest either submitting for an opinion and/or providing a preliminary mock-up of the piece when submitting for review to determine the plausibility of the proposed APS. Final ruling would be pending an official review.

Hello @maryssa

Our understanding is that you are asking in reference to the “Renewal Management Dashboard" and a piece needing to be 100% pickup . In this context, yes, it would be acceptable to update the date to match the new TMA. Note that review to ensure that the piece is not affected by the TMA update would be required. If additional copy change is required to address the TMA update, additional fees and a new timeline may be applied.

@jennifer-carroll I will do that. Thank you for your help!

Hey @elena

A message of “talk to your doctor” or “talk to your healthcare provider” or “talk to a healthcare professional” can all be considered in both branded patient information pieces and branded direct to consumer (DTC) pieces as they are broad and all encompassing. When you state a specialty, there are implications. For branded patient information pieces, there will be considerations about the specialty that the patient is being directed to in the context of the brand. For example, we’d likely question “talk to your urologist” in the context of a cardiovascular product. This would be assessed during the review process.

For branded DTC pieces, it would not be acceptable to specify a specialty as this would suggest therapeutic use in violation of the Food and Drugs Act.

Hey @llmktg

The following response is provided as general guidance and should not be seen as an exhaustive list of considerations.

Broadly speaking, when creating a branded patient experience video, remember that in a branded context, all content has implications for the brand. Also, keep in mind that patient-directed APS should be non-promotional, and HCP-directed APS should be supported by evidence meeting PAAB Code requirements. Subjective experience is often hard to qualify with blinded statistically significant data from randomized control trials.

For a patient-targeted APS: Because a person’s experience is subjective, such a video may have promotional connotations, which would not align with section 6 of the PAAB code (see PAAB Q&A 450). It is possible to create a non-promotional video objectively highlighting the injection preparation + administration steps. A disclaimer should be added stating something similar to “Actual patient depicted. May not be representative of the general population.”.

For an HCP-targeted APS: A patient’s experience with the injection process is considered similar to a testimonial (s3.1.3). Testimonials that are consistent with data supported by acceptable evidence (see PAAB Q&A 703), may be considered. A branded video for HCPs may be created depicting a patient injecting themselves with the product, so long as it is objective, accurate, and complete (s2.1). A disclaimer should be added stating something similar to “Actual patient depicted. May not be representative of the general population.”.

@jennifer-carroll Short and sweet, thanks Jennifer!

Hey @lora_nolan

Yes, the mentioned guidance applies equally to new products as it would to established products. The pre-NOC submission pilot is not related to this update. It is an administrative guidance reflecting a process change where we moved from requiring final draft TMA and only accepting 2 core pieces prior to NOC, to accepting submissions for review at any stage of the TMA development and with no limit on number of files (at PAABs discretion). Please refer to the pre-NOC guidance for fees that may apply in addition to the standard initial fee should a TMA update be made mid-review of a pre-NOC APS. There is no difference from a Code application perspective in how a pre-NOC review is applied. The duration guidance also applies to pre-NOC submissions. Once a notice of compliance (NOC) is granted for a product, an APS for the product may contain claims noted in the study duration guidance that are related to “out-of-TMA updates” to TMA studies (these would be data from TMA clinical trials that are not mentioned in the TMA), if these claims and their supporting studies are consistent with the TMA, are pre-planned, published and peer reviewed, and do not pertain to NOC/c products or Class B opioid products. Section 1a of the guidance provides further details for this specific scenario.

Hello @natbourre

The training speaks to an option for gating that would meet a sufficient barrier. The current methodology you are using (D.5 section of the PAAB Guidance for gating mechanisms) remains to be a valid gating mechanism. The guidance document provides additional options that would meet Code section 1.4.k.E. A gate should meet the standards outlined in the guidance which could be met by using a third party or in-house verification as one option.

Hi @gmc

We have reviewed such sites. In general, the URL for the website (brand.ca) is to the homepage where gating can be started with the DIN number for the patient to enter. Once the patient is in the site, part 3 of the Product Monograph will dictate whether patients can see other therapeutic areas/ indications, i.e. is there only one part 3 for all indications or separate part 3s for separate indications? (we refer you to Section 1.1b of the Guidance on Branded Patient Information). If they are separate part 3's, then one suggestion is for the site to offer an option for the patient to enter their indication in order to enter the appropriate section.

Hey @mbos

There are a few regulatory issues that must be considered. For example, the approval process must not be discussed in advertising per C.01.007 of the F&DR. Another issue is that one cannot convey a message that implies a Health Canada endorsement/recommendation.
We could consider a message which is factual such as “the indication of Product X has changed from NOC/c to NOC”. This message should be presented in a manner that is separate and distinct from other messages (e.g., pivotal trial data that may or may not be the basis for the change).

@jennifer-carroll said in Defining "data gathering is complete" for trials:

1.8

Thank you!