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Hello @gmc Hard to say whether this is even acceptable without looking at the study, but as a general question, we can state that this would require highest level fair balance. It is an implied claim of efficacy which would likely require quantification from the study (i.e., presentation of data). If it was stopped due to safety concerns, that would also prompt inclusion of that information and render it subject to highest level fair balance. With respect to “what other data is required for it’s inclusion?”, this is a review specific question. Please submit for an opinion as there are a number of factors that would need to be considered.

Hi @gmc This would be considered a review question. Please submit for opinion or full review. Note that other copy and content on the page impacts the acceptability of a message. As a general guiding principle, content on the described landing page would need to meet patient, HCP, and DTC regulations (i.e. it would be subject to the applicable sections of the Food and Drugs Act and Regulations, Health Canada policy documents pertaining to consumer advertising, and the PAAB Code).

Hi @gmc It is acceptable to acknowledge the contribution from HCPs in the development of an APS. Note that the content within the piece would still be required to meet the standards for evidence (i.e. individual opinion that is not supported by evidence would not qualify as an authoritative source). The overall principle of not associating branded and unbranded should also be adhered to. Wording would be discussed during the review to ensure that it does not contravene advertising regulations. We’d encourage the sponsor to also check with HCP governing bodies and other trade associations to ensure there are no concerns with the activity.

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.

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.).

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 @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.

@gmc In PAAB’s view, Canadian medical/regulatory review of international conference materials is an appropriate mechanism for determining whether the sort of disclosure statement outlined in the fourth bullet of the Distinction document’s section on international conferences is required to be affixed to the ad. However, tailoring the ad for Canadian HCPs (beyond simply affixing the aforementioned sticker) would likely render it subject to all applicable Canadian Federal advertising regulations, regardless of whether the revisions are implemented by the parent company or the Canadian subsidiary. Given that the ad was generated from a non-Canadian label, its deviations from the Canadian regulations likely go beyond the product’s local naming/branding conventions and risk disclosures. The course proposed in the question would therefore appear to render ad subject to Canadian advertising regulations while falling short of achieving full adherence with those regulations. The resulting ad would likely also deviate from the regulations that are applicable in the jurisdiction from which it originates. In our opinion, based on the limited information provided, it would be best to EITHER: • Make no modifications to the ad itself, and instead affix a sticker conveying that the product is not authorized for sale in Canada or that the product is authorized under a different name for different indications in Canada (if applicable). Canadian HCPs should be invited to refer to the Canadian monograph. • Revise the ad so as to fully bring it into adherence with all applicable Canadian regulations (and confirm this through the PAAB preclearance mechanism).

@gmc PAAB does not regulate representative activities but agree with the primary principles of not promoting off label use for drug products and not distributing unbranded materials in a branded booth. The PAAB Code requires use of PAAB reviewed materials. Please note that respective pharmaceutical trade associations generally have a code of ethics/conduct that may help guide representative activities. In addition, the Food and Drug Regulations apply to all advertising activities.

@gmc Yes, unbranded patient and HCP websites can link to corporate PP and TOU pages post gate.

Good morning @gmc Similar to Q&A 332, p=ns data from the PM clinical trials section may be included in advertising providing there are no conclusions or claims that extend beyond that found in the PM. This is possible regardless of whether it is primary, secondary or exploratory.

Hello @gmc , hope you had a great long weekend. A series submission would be acceptable for this type of APS if it meets the series submission requirements of 60% pick-up.

Good afternoon @gmc The form is not exempt as service oriented messages to patients/HCPs are still subject to review. See FB on PSP enrolment forms for related information.

Hello @gmc No. This would not meet the specifications outlined in Guidance on Generating the Three Levels of Fair Balance

Good morning @gmc PAAB has issued advisories and guidance regarding formulary claims since 2010. In addition, we have received feedback from formularies regarding the presentation of formulary coverage in APS since then. The 2010 eFile may not reflect the more recent information and should not be used as precedent. We suggest submitting for an opinion should there be more specific questions regarding the proposed project.

Hey @tmcm Yes, a compliant unbranded disease information pieces/tool could be created to be provided to patients by healthcare professionals. Patient information should be supported by consensus groups and authoritative sources. Guidelines are considered an acceptable source for disease targets in an unbranded patient piece.

Hello @tmcm If the visual does not allude to therapeutic use then it is likely exempt. Note that when you link exempt content to advertising, the exempt content may no longer be exempt. If the booth contains promotional claims, it would be prudent to convey in the review of the booth, the content of the conference banner which is directing the user to the booth so that we may ensure it does not exceed the regulations.

@tmcm Thank you for your question. The proposed APS does not meet exemption criteria as per Code section 1.5. It is considered a promotional message and would require PAAB review. As an advertising message, bolding may be possible depending on the context. The appropriateness would be determined during the review process.