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.

@jennifer-carroll thank you for clarifying! That's very helpful.

Hey @smurcar

It is not possible to know if the piece would qualify for a minor update from the description. The content structure remaining the same is not what will determine eligibility for a minor update. Significant new presentations may be added within a content structure that would extend beyond the spirit of a minor update. For example, a new data set within a pre-existing ‘Efficacy’ content section. An eligible minor update is an update to an existing presentation.

The copy “existing presentations is updated with more recent information of the same type” was generally written to reflect updated formulary coverage, updated distribution numbers etc. A patient case is more complex as content within it may prompt additional support to be included in the piece. Additionally, the stacking of patient cases can create emphasis on particular characteristics which may not have existed as a stand-alone patient case. We would suggest submitting for consideration as a minor update, with the understanding that it may prompt broader change in the piece which would incur a revision to the fee.
Hope that helps.

Hello @tk2022

Could you please provide additional information on what aspect of “inclusion of patient cases in a branded HCP tool” you are looking for clarity on? In advance, please note that there are a number of forum posts which address the use of patient cases. We suggest searching “patient case”.

Hello @natbourre

An unbranded APS can be considered exempt if it discusses only disease information without any mention of or allusion to drugs/medications/pharmacotherapy. Because the tool would be alluding to medication/pharmacotherapy via discussion of MoA, the APS would not be considered exempt.

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.

@jennifer-carroll that makes sense, thank you for clarifying!

Hey @natbourre

This would be an opinion for exemption. We suggest submitting with additional details around the therapeutic area, talks, sponsorship, influence over content, relationship with the speaker, etc. in order for PAAB to make an assessment.

Hi @karen-taylor,

A claim that references a vaccine product being publicly funded in a branded DTC APS can be considered. While claims would be assessed in the formal review of the piece, please note that “… free of charge …” may be potentially misleading. While it may not directly cost the patient any money, the vaccine would be paid for by the government (i.e. societal costs). Alternatively, claims such as “…may be publicly funded in your province. Speak to your doctor to see…” can be considered if it is accurate. Regarding the second example “… publicly available in Canada”, if certain provinces/territories do not cover the vaccine, then it would be misleading to state that it is publicly available in Canada overall. Please see the Food and Drugs regulations for DTC advertising and also ensure that this type of DTC-advertising is not linked to any DTC-information pieces (please see Q&A 716).

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.

@jennifer-carroll Thanks very much, this is helpful!

Hi @cynthia-tab1,

The following is provided with the understanding that the rep can only select one fragment per email in the example. In general, if the fragments are different messages, then they may not be reviewed under one submission as there will be discrete emails with distinct messages sent. Assuming the common content of the emails exceed 60% pickup, the emails should be submitted as a series for each separate fragment with an initial parent file and all subsequent fragments submitted as a child file. If the fragments are the same message but written in varying language, then an iterative submission may be possible under the same efile number. Please see our submissions guidance document under 2.2.1 (b) iterative submissions and (c) Other series for additional information.

Hi @maryssa,

Pre-NOC is considered when a drug product has not yet been approved for use in Canada. For unbranded disease information material without mention of any drug treatment/pharmacotherapy or pre-NOC editorial material, they may be submitted for full review or opinion at any time. Please see our Pre-NOC Corporate/Editorial communications for additional information and cautions regarding pre-NOC communications. While the unbranded disease information without mention of any drug treatment may meet criteria for exemption, we suggest submitting for an opinion as the PAAB reviews help to ensure the company and materials are not inadvertently in violation of C.08.002 of the Food and Drug Regulations.

Hi @username,

Without knowing the specifics of the file you are speaking to; we can convey that experience claims tend to have nuances to them that are set by the context around them which the reviewer can help you better understand in the context of the review. In the context of this being the only claim on the page, the copy “X years in Canada across indications” is inherently misleading as not all indications have been authorized for X years. It creates an erroneous impression for time on the market for some indications. For this type of experience claim, the underlying PAAB code section 2.1 and principle has not changed. The request for clarity and accuracy regarding years of experience have been applied for many years with the initial appearance of such claims in advertising.

We do our best to inform clients about changes and will continue to look for opportunities to do so. When an issue does not affect a large number of pieces, we do tend to error on the side of conveying the change in files when the issue is noted. This helps to ensure that we are not overwhelming clients with every review ruling. We can look for opportunities to increase that scope and frequency.

In the second example, there has been no change to the requirement to disclose to HCPs when you are directing them to content that was designed for consumers or patients. The perception that this is a change might be rooted in the fact that PAAB noted that clients were adding consumer messaging to HCP pre-gate landing pages. As such, we would ask for the clear disclosure that they were being directed to content intended for a consumer audience. The nature of the content on the pre-gate page changed, which is what prompted the request. The application of the Code did not change. The reviewer can help explain the nuances of your example in the file. Please reach out through efiles.

Hi @supraja

When a Risk Management Measure/Tool (RMM/T) is intended to be distributed with any other PAAB reviewed pieces, the entire package is considered in context and should be submitted as a separate PAAB review/opinion. We are unable to comment on the compliance of the proposed APS without assessing the content of the APS and suggest submitting for review or an opinion. During the review, we would be able to provide advice on the acceptability of the APS content and its linkages. Any folder intended to be combined with an RMM/T is also subject to PAAB review. Please see our guidance document on RMM/RMTs for context of use and other information.

Hi @supraja

In general, actual patient images may be used in HCP materials. Please see the following PAAB Forum post Q&A for additional details. For patient materials, actual images may also be used with a disclaimer when consistent with part 3 of the product monograph but with a caveat. Patient materials may not contain promotional claims as per code section 6. Patient images will not be accepted if they are determined to be promotional.

@llmktg

Graphs and tables that are informational in nature are generally not considered creative imagery. Creative imagery usually refers to visuals such as photos or images that are often intended to accompany a claim of benefit or to infer a claim of benefit.

@sean-cai

Hi Sean.cai.

The development of the Renewal Management Dashboard was done in collaboration with both an agency committee and a manufacturer committee. On page four of the attached Renewals Management Dashboard Guide, found on the Renewals Management Dashboard page of the PAAB website, the process for batching and notification settings is identified to address your concerns about email volume.

Hello @gmc

Please see Appendix A for turn around times. Turn around post approval is impacted by the final approved PM and if it is different from the PM in the previous round of review.

Whether ARO is available for additional pieces would depend on the ARO requirements (i.e. length, new content, etc.).