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PAAB Q&A

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PAAB Notice
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

  • 238 Topics
    390 Posts
    Jennifer CarrollJ
    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.
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    @jennifer-carroll Thank you this helps!
  • 7 11
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    11 Posts
    Jennifer CarrollJ
    Hello @abhi-patel While consumer advertising for Schedule D health products (e.g., vaccine), and ethical schedule health products fall within the scope of PAAB services, consumer advertising for OTC and NHP products does not. Please note that Health Professional directed advertising of these products falls within the scope of the PAAB Code.
  • 38 Topics
    56 Posts
    Jennifer CarrollJ
    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.
  • 84 Topics
    122 Posts
    Jennifer CarrollJ
    Hey @maryssa The relevant standards of the PAAB Code of Advertising Acceptance are applicable to APS directed at HCPs and APS directed at patients when there is HCP involvement. This remains true regardless of how else the APS may be used. In questions 1 and 2, leaving physical copies of APS in an HCP's practice constitutes distribution involving the HCP. The HCP maintains full control over which materials are allowed to remain in their practice. It would be prudent, as a best practice, to seek permission from the HCP before leaving such materials in their practice. In question 3, the messaging is directed specifically to the HCP. The fact that the messaging is about a consumer campaign does not exempt it from the applicable provisions of the PAAB Code for the message itself. If inclusion of the DTC website/material is for awareness only, it would not subject to PAAB review. However, should there be copy that suggests the material is intended for consumption by the HCP or disseminated to patients through the HCP, e.g. “Tools and resources…”, “Learn more at…”, then the website/material would be subject to PAAB review. Conversely, in question 4, the HCP is receiving the message as a member of the general public. Therefore, the PAAB Code does not apply. While the question may be framed humorously (I would hope), the general public includes individuals from all walks of life, even HCPs. Don't forget the Advisory - APS in Patient Interaction Areas as well.
  • 70 Topics
    117 Posts
    Jennifer CarrollJ
    Hey @cscholes We understand that LinkedIn is an ungated platform and open to consumers. As such, the site is subject to consumer regulations similar to PF question 458 and is highly restricted for prescription advertising. Targeting to HCPs within the open platform may not guarantee that consumers won’t see the ad as well. Please also see this linked PF question and our Guidance on Gating Mechanisms for Healthcare Professional Targeted Digital Assets and subsequent clarification document Gating Mechanisms for HCP Digital Assets (designed in collaboration with Health Canada) regarding HCP validation. How HCPs are identified and verified, the nature of the targeting and how well it can limit the audience to only validated HCPs would be information that is required as part of the review process. PAAB will provide advice and direction based on the Health Canada DTC regulations, the PAAB code principles and the information that the sponsor can provide for the restriction of the intended HCP audience within this consumer space.
  • 174 Topics
    218 Posts
    Jennifer CarrollJ
    Apologies for the delay @SMurcar. We were in the process of upgrading the forum over the last two days. As the piece would be moving from two sided to one sided this would change the flow. The content in the top section may set context for the bottom section depending on the formatting and flow. We would suggest submitting for a minor update (if the resizing is intended to replace the small postcard altogether) so that we can assess the revised visual flow to ensure all aspects of the Code remain met. The addition of the QR code as described above could be considered as a minor update. Please see the Submission Guidelines for more information
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    124 Topics
    193 Posts
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    Can you please clarify if pooled long-term extension data can be considered, assuming the original pivotal studies are part of the TMA? I've review the guidance on duration of clinical trials and it seems to assume that the LTE is the continuation of a single study. What if there is a pre-planned open-label LTE where patients from the various pivotal trials are fed into one pooled LTE?
  • 60 Topics
    72 Posts
    Jennifer CarrollJ
    Hey @dmauri Section 7.3 of the PAAB Code states “Advertising with Product Claim Link to Terms of Market Authorization: One of the following must appear prominently within the main advertising message of the APS: Electronic link(s) to the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) URL(s) for a webpage containing the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) accompanied by a statement that these documents are also available upon request through a stated phone number. The definition of “Terms of Market Authorization” can be found in the Code and reads as follows: Information in the Product Monograph, labeling and product license and the document that assigns a Drug Identification Number (DIN), Natural Health Product number (NPN) or homeopathic product number (DIN-HM), including related product labeling material and prescribing information, authorized by Health Canada. When a Product Monograph is the basis of authorization, it should be linked. If authorization was granted based on a Product License, providing a link to that document would meet the requirements of section 7.3. The TMA document would be the basis for review of the ad.
  • 8 Topics
    16 Posts
    Jennifer CarrollJ
    Hey @vt Yes, you should ensure that the 4 criteria are still followed. These criteria still exist in the distinction document, they are just mentioned across the document and therefore not repeated in this section. For example, the “Content and Context Factors” section in the “Overview” states: • A message involving unauthorized health products or unauthorized indications, in a context such as educational activities, may be considered promotional if: • the message does not caution that the product’s safety and effectiveness are still under investigation and that Health Canada has not yet granted market authorization Within the Educational Activities section, things that could make the piece promotional are: • The limitations of the data and of the health products are not adequately discussed • Reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a health product are disseminated by the sponsor or its agent to a wider audience These are in addition to the copy under the revised heading of “Canadian and International Conferences”. In general, if it is a Canadian conference, the content should be created by the Canadian office. If it is an international conference, the content should be created by the parent company and should be adequately disclaimed. Remember that the distinction document is not intended to be an exhaustive list, but a set of guiding principles with examples throughout to help assess context and content. The examples in the “Overview” section should be considered when evaluating individual activities.
  • RWE Presentation

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    Jennifer CarrollJ
    Hello @lora_nolan This is a review question. Per the Community Guidelines (see top right corner), this does not meet the use conditions for the Forum. Please address review questions through the appropriate channels by submitting a ticket for a call with the Reviewer through eFiles.
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    Jennifer CarrollJ
    Hey @supriya We’re unclear about the request. We can provide an example of how to cross-reference: Insert an asterisk ( * ) at the point in the text where you want to reference the footnote. At the bottom of the page, add the corresponding footnote, also marked with an asterisk ( * ). Cross-references must appear on the same spread as the claim. Multiple claims can be linked to the same footnote if the footnote would be the same for each claim. If this is not the question, can you please provide additional context.
  • Is there a maximum number of keywords in an efile?

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    Jennifer CarrollJ
    Hey @maryssa There is currently no limit on number of “keywords”.
  • QR code to replace PM URL in FB copy

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    Jennifer CarrollJ
    @mgregory Our apologies. The above was posted prematurely. Please note that as per PAAB code 7.3.1a, "The URL may be supplemented, but not replaced, by an electronic coding system, such as a QR code or a bar code". For print media, please be reminded that the telephone number must be accompanied with the URL +/- the QR code.
  • DTC advertising: what qualifies as "price" in "name, price, quantity"?

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    Jennifer CarrollJ
    Hi @maryssa Although 'price' generally refers to the monetary amount associated with the patient's acquisition of the sponsor's prescription product, insurance coverage and corporate service programs addressing acquisition costs could also potentially be presented in a manner that complies with the name, price, and quantity restriction. Acceptability of the proposed claim in the above question may be possible depending on the balance of the context. This can be addressed during the review process.
  • When can we use brand names in claims when reference uses generic?

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    Jennifer CarrollJ
    Hey @maryssa We’re not sure of the specifics to the case that you’re referencing in the beginning of the question so we cannot confirm your understanding. We can provide general guidance on place in therapy claims. Place in therapy can be supported by guidelines when it’s consistent with the indication. The PAAB document “What constitutes current medical opinion & practice” states “PAAB has received requests from consensus groups to ensure that the proprietary drug name [brand name] is not included within a claim directly referring to the guideline if the guideline recommendation only cites the non-proprietary drug name [generic name]”. We refer you to the examples in the above-mentioned document. Therefore, a claim that a product is recommended first-line per guidelines X, would require that the brand name be specifically mentioned in the guideline recommendation. Otherwise, the generic name should be used. For the second scenario (“BRAND NAME X has an indication in its PM, in combination with generic name Y. Could we have a header in an APS that says "BRAND NAME X + BRAND NAME Y" supported by the combined indication from BRAND NAME X's product monograph?), the answer is no, as per the principle outlined above (consistency with the authorized indication). We are also aware of cases where Drug Y does not have an authorized indication for combination with Drug X. If the question was intended to be in reference to guidelines, the above response (direct mention by brand name in the guidelines) would also be required.
  • Visual connection between DTCI and unbranded HCP-facing DSE

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    Jennifer CarrollJ
    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.
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    @jennifer-carroll thank you for clarifying! That's very helpful.
  • Does switching in approved patient profiles constitute a minor update

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    Jennifer CarrollJ
    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.
  • Patient Cases

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    Jennifer CarrollJ
    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”.
  • Exemption for unbranded tool of single product within category

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    Jennifer CarrollJ
    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.
  • Pharmacogenetic trials and RWE

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    Jennifer CarrollJ
    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.
  • Lives covered by private insurance message

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    @jennifer-carroll that makes sense, thank you for clarifying!
  • Invitation to KOL talk at a national conference

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    Jennifer CarrollJ
    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.
  • "Free" callout for vaccine product

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    Jennifer CarrollJ
    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).
  • Branded Website vs Corporate Website URL

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    Jennifer CarrollJ
    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.
  • APS discussing diagnostic test

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    @jennifer-carroll Thanks very much, this is helpful!
  • Fragments within a RTE

    rte
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    Jennifer CarrollJ
    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.
  • When does the pre-NOC period begin

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    Jennifer CarrollJ
    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.
  • PAAB changes to application/requirements for pieces

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    Jennifer CarrollJ
    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.