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Hello @gmc As per our response above, there are many aspects that would impact acceptability. It is highly probable that the proposed link above would present an issue because the patient would know certain things about the medication that was prescribed to them (i.e. the indication). By linking to a pre-gate page that has a second medication which the patient has likely not been prescribed, it may be considered direct to consumer advertising. This is because the patient could start drawing inferences/conclusions about that second medication, even if they only see the name of it on a pre-gate landing page. This would be assessed and discussed during the review process.

Hey @kellyyefet We were unable to locate the quote “if it’s mean to be gated” in the above copy and therefore cannot comment on what is meant by it. The possible forms of gating are outlined in the gating guidance document which can be found on the PAAB website under resources. To clarify “Note that if the branded site URL is intended to be the gating mechanism…” in our previous response, we were referring to the context where de-indexing is the form of gating. If this de-indexed URL is acting as the gate for your brand it would not likely meet the requirements. Note that “soft gate” is not a term that PAAB or Health Canada use. A website which contains information which goes beyond what is allowable in the consumer space requires a gate which ensures access is limited to the intended audience.

Hey @kshulist As per the principles noted in Q&A 508, if the published paper conveys a statistically significant improvement in the absolute risk reduction for the response rates (with multiplicity adjustments performed when required to manage risk of type I error), the NNT may be calculated.

Hello @cchristopoulos The primary reason for the implementation of the RWE guidance document was to provide some flexibility around presenting evidence that was not previously accepted, in order to allow additional clinical data. Code section 3.1.4 states “Claims based upon laboratory or animal testing reports should be separated and cannot be used to imply clinical significance, unless there is evidence of a valid clinical correlation”. Unless the PK/laboratory-type data are unequivocally shown to have clinical relevance reflected by widely-accepted medical opinion and practice (e.g. authoritative consensus guidelines) and determined to be a valid endpoint (an example of this would be viral load in HIV), then a PK presentation would also not fall under the scope of the RWE guidance document.

Hey @GMC This copy would be reviewed in the context of the entirety of the piece. The context of the message “dispensed as written” will matter. See also the PAAB advisory on Advertising messages referring to "no sub".

Hey @copycallosum It’s difficult to capture all aspects that may make this activity exempt versus an advertising/promotion system (APS) subject to pre-clearance review without seeing all the tools and how they are used. The general response is that when you link advertising (APS) and non-advertising, everything becomes advertising (this is regardless of whether it is branded or unbranded). If HCPs are being encouraged to link disease state information to a consumer campaign, all aspects of the consumer campaign should be considered in the context of the dual audience (HCP and consumer). We’d suggest submitting for opinion as mention of management can be implicit or explicit and is broader than just mention of a product/brand.

Hey @cchristopoulos Descriptive statistics in an RWE do not preclude the use of the publication in an APS as long as they are pre-specified.

Hey @constance. Please find response below. Phase 1 is not complete. There will be rounds of consultation with industry prior to launching to ensure that we are developing as efficiently and in the most supportive manners. Please stay tuned as we look for assistance in finalizing technical validations, user testing, and ensuring adequate support resources are in place. We anticipate these steps will be completed by the end of Q2 and will communicate a go live date as we approach completion. Manufacturers have been informed about the initiative through communications and the townhall. PAAB has also spoke to this initiative at a number of conferences. We have also invited manufacturers to reach out with specific questions especially surrounding privacy and security. We anticipate that the level of understanding may vary. The purpose of the debrief meeting is to ensure that both agencies and manufacturers have a shared understanding of the initiative while also inviting feedback and suggestions as we develop and scale. As their agencies, your role is pivotal in supporting their implementation efforts, but the debrief aims to equip everyone with the necessary context and clarity to move forward confidently. Please rest assured that we will develop training and guidance related to the new policies and procedures to ensure both agencies and manufacturers are equipped with the knowledge they need to successfully utilize the new features’. We anticipate that there will be a mixture of manufacturers alone and agencies in collaboration with the manufacturers participating in these meetings. Who participates is at the discretion of the manufacturer. If agencies have agency specific questions, we are also happy to set up these meetings. It may also be possible that the first meeting will be solely with the manufacturer and then they may opt to bring in agencies as it becomes necessary. Please note that currently, these debriefs are not training sessions for the use of new features. These debriefs are intended to discuss security, privacy, and whether/how proprietary manufacturer generated content will be used as we progress through Phase 1 and 2 of the initiative”. We hope that helps. Thank you for the questions and continued engagement.

Hey @maryssa A search of the PAAB resources at paab.ca should turn up “What constitutes current medical opinion”. A search of “guidelines” on the forum should turn up 593, 743, 77, among other results. HTH.

Hi @tk2022 Reprint holders are a common term we see in advertising for the “folder” which houses the reprint. This can be as simple as the brand name, study title, and fair balance, or house complex claim copy. The content that appears is at the discretion of the sponsor as long as it meets the advertising requirements. All requirements from Section 2 of the PAAB RWE Guidance would apply. Yes, it is applicable to virtual distributions. An unaccompanied (by any form of verbal or written information designed by or on behalf of the manufacturer for the purpose of promoting a health product) study reprint pdf in its original form (i.e. unaltered) is exempt from PAAB preclearance but not advertising regulations, however if additional verbal/written messages or context is added through the distribution channel, it may not be exempt as noted in our previous response. We suggest submitting for an opinion if you are unsure.

Hi @dmauri This would not apply to comparative data. As per the first sentence “statistical analysis to support inclusion of comparative therapeutic data” is required. The comment also states that the AEs have to be aligned. Your original question appears to suggest that you are looking to speak to AEs which are not presented in the TMA and therefore would be difficult to demonstrate alignment.

Hey @alee No. There can be no mention of unauthorized products/investigational products as they have not yet received terms of market authorization. The discussion of ongoing studies is to demonstrate the company’s commitment to additional research of approved products.

Hello @constance Similar to our response above, a description of the outcomes for assessment and the listed study information noted in your question, may be included in an APS in a non-promotional manner , prominently disclaimed for the off label uses, and also prominently labeled “Ongoing studies”, in a separate tab/page that is away from the promotional content of the APS. Please also see this Q&A 223 for additional information on the presentation of ongoing studies in a non-promotional manner.

Hi @constance General enrollment based on geography may be considered when presented in a clear manner and with adequate disclosure of the pertinent PSP program information. For the highlighting of patient characteristics such as gender and age, acceptability is dependent on the balance of the APS content and supporting data as there will be subgroup emphasis considerations with such highlighting.

Hey @gmc Yes, inclusion in the logo qualifies. The answer above is based on an older version of the code. The current code section 2.2 states: In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible. It can appear anywhere in the piece as long as it appears at least once.

Hey @matt-s17 If the warning and precaution is clearly limited to one indication which is not presented in the piece, then no, it would not be required in a piece which did not have mention of that indication.

@healthymind The Health Canada Distinction between advertising and other activities document is separate from the PAAB code which is for advertising directed to health care professionals and patients as per Code Section 1.3B. Code section 7.5 provides guidance for editorial advertising/promotion systems (APS) and states that it should be clearly identified as advertising to distinguish from other editorial presentations; hence, this requires that the manufacturer’s name be included in unbranded editorial APS. Note that code section 1.4K.A. also provides direction for digital media for various content including unbranded information and indicates that the pharmaceutical company sponsor should be clearly stated in the advertising.

Hello @danielle Firstly, I apologize for the delay in response as I was on vacation. We’ll look to modify internal processes for the future. An HCP reminder ad in a gated space, limited to the indication, brand colors and logo with no creative/visuals, would prompt the inclusion of the lowest level fair balance regardless of the black box warning. There are no additional requirements for lowest level fair balance for products with black box warnings. Be careful, as the question above is about DTC. As noted in the response, “reminder ads” in the DTC space are limited to “name, price, quantity” (no reminder ads are permitted for controlled products). If the ad is going to appear in an ungated space, it should not contain the indication or allude to therapeutic use.

Hey @taylor-murphy Assuming “restricted access informational website” refers to a post-gate medical information site (non-advertising), a keyword-based search functionality is still considered best practice. As a reminder, the medical information letter (MIL) responses should only be provided in response to a specific request. Therefore, the keyword-based search functionality should be set out to require narrow searches that yield narrow search results. For example, the user would have to search “[drug name] AND order AND prepare AND dispose” (using the Boolean operator “AND”) for this MIL response to come up. Searching any one word, “order”, “prepare” or “dispose” should not bring up this article as the topics discussed within the MIL response go beyond the single term searched.

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.