714
If a representative during a social meal mentions to an HCP a reference to a slide that was viewed at another meeting to HCP's with regards to utilization rates of a genericized molecule, is this considered a violation?
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View Answer [+]
The PAAB code applies to all advertising pieces (i.e. detail aid, website, email, etc.) distributed via all media (i.e. print, audio, visual, electronic, etc). A verbal communication between the representative and the healthcare professional does not fall under the scope of the PAAB code. However, verbal communication between a rep and an HCP is covered by the Food & Drugs Act and Regulations. If you are unsure about a specific topic or claim, a good rule of thumb is that if the content would not be approved in a print piece, the rep should likely not be discussing it verbally with a physician.
713
Can ongoing studies for a group of products (same therapeutic category) be discussed in a Corporate APS, or must this be done in individual branded APS? For example, a company has a portfolio of diabetes drugs that with ongoing research into weight loss indications, and would like to produce a single piece discussing all trials.
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View Answer [+]
The main message conveyed in a corporate APS must be related to the company and its programs or services. If the messaging in the piece is strictly related to broad program-level messaging (e.g. a total of 1000 patients across studies in our cardiovascular research program), then the piece may meet the requirements of a corporate APS. That said, discussion of ongoing studies for an existing portfolio of products would likely be reviewed as a branded APS, as it relates to individual brands. This information could potentially be presented in a single APS as a co-promotional tool, with the information relating to each individual brand being separate and distinct. Reference to the ongoing studies must be made in a non-promotional context, with no prominence on information that has not been authorized by Health Canada. Be mindful that as branded tools, these pieces will require the indication and fair balance copy. Refer to AskPAAB question 223 for more information on how we review ongoing studies, including studies involving off-label use, in branded APS.
712
We have an online newsletter where we post healthcare-related information, as well as society news pertaining to our association. Our member and supporter base primarily consists of hospital pharmacists as well as a small number of architects, students, and pharmaceutical companies. We can set-up advertising on the site to require a login to limit access by the general public. My concern is with the students who are not yet healthcare professionals, the pharmaceutical organizations, and the small number of architect members. Would their exposure to pharmaceutical advertising go against PAAB standards, even if we include a disclaimer that the advertisements are meant for healthcare professionals only? When we used to have a print journal that contained advertising for pharmaceutical products, the same individuals would have received copies of it. To my knowledge, this was not an issue in the past. However, we would appreciate some guidance to ensure we are being PAAB compliant, as online advertising is new to our association. Thank you kindly.
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View Answer [+]
The regulations that are applicable to your question emanate from Health Canada rather than the PAAB. In other words, the question in this case should be are you Health Canada compliant rather than are you PAAB compliant. Nonetheless, we can provide an advisory opinion on the matter.
It sounds as though the publication does not target Healthcare Professionals specifically. As such, the consumer advertising regulations set the boundaries for which ads are permissible in the publication. These regulations differ based on the Federal Drug Schedule of the product being promoted. As an example, direct-to-consumer advertising for prescription drugs is limited to name, price, quantity and direct-to-consumer advertising of narcotics is prohibited. These regulations apply to both digital and print pieces.
711
Can patient survey data from CADTH be used for an unbranded tool on current patient experience and behaviour?
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View Answer [+]
CADTH is an important tool for explaining recommendations for funding decisions, but it is not designed or intended to support product claims in drug advertising. See AskPAAB question 541 for more information on this topic.
For claims related to patient experience and behaviour which do not relate to pharmacotherapy (i.e. disease attitude and opinions), then we may consider surveys as a source depending on the design, and execution of the survey. However, the primary source to support these claims should be the survey itself, not the CADTH document.
710
For Help-Seeking Announcements, the Distinction Between Advertising and Other Activities states "there is no implication that a drug is the sole treatment available". Does this mean no implication for a single brand within the context of available drug treatments, or no implication for drug treatment over non-drug treatment?
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View Answer [+]
The Health Canada Distinction Document has the following three provisions relating to Help Seeking Announcements:
- no specific drug is identified,
- there is no implication that a drug is the sole treatment available for the disease or condition, and
- no drug manufacturer's name is included.
Although the question relates to the 2nd point, it is important to interpret it in the context of the 1st. Generally, when PAAB has evoked the 2nd provision, it has tended to relate to the statement referring the patient to the HCP. For example, the statement “If you have any of these symptoms, consult your physician for discussion about the treatment for condition X” would evoke the 2nd provision. Even if there is only one indicated healthcare product, the statement should refer to treatment options or management options (includes non-pharm options) so as not to suggest there is only one treatment available for the condition.
709
For a product with two different administration formats (eg. syringe and pen), is it permissible to only advertise one format in APS (with no mention of the other device)?
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View Answer [+]
Similar to AskPAAB 704, there are a number of scenarios which could result in either requiring both administration formats to be included in the APS, or allowing the focus on just one. These would depend on both the content in the TMA and the claims which are being made in the APS. For example, if the piece is promoting an indication in which the product is administered using the pen, then the selective promotion of administration with the syringe would be questioned. As the answer to this question is dependant on the specific TMA and the claims made in the APS, we suggest submitting this to PAAB as an opinion request.
708
If Product-A is a combination of Drug-B and Drug-C, can the mechanism of action information from the Drug-B and Drug-C Product Monographs be used in Product-A advertising? The Product Monographs for combination products usually contain less information regarding their components (for brevity), however mechanisms of action should be identical regardless of formulation.
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The review of mechanism of action claims for drug A would be based on the Product Monograph for drug A. We would not accept the assumption that combining the two products does not in any way impact the mechanism of action of either of the individual drugs. This concept would require direct support from the drug A PM, in which case, content from drug B and drug C PMs may be considered. This assessment would be conducted on a case-by-case basis and would depend greatly on the information/language in the drug A PM. For example, if the PM for drug A says “Please refer to the individual product monographs for Drug B and Drug C for more information on the mechanism of action” then we could consider the MOA content from the respective PMs.
707
Hi, For the balance copy requiring a direct link to the Product Monograph - the guidelines state that a link to the Health Canada database along with DIN number would work in lieu of a corporate URL. If going this route, is it sufficient to say: "Search the Health Canada Drug Product Database and search DIN XXX for...." OR must the database URL be written out? It is quite long: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) Much thanks!
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View Answer [+]
The guidance document state “the manufacturer could have used a URL leading directly to…the Drug Product Directory search page on the Health Canada website”. There are no requirements to provide the DIN, as a search can be conducted simply using the product name.
The link to the TMA in the fair balance may be either the complete url, which is required in the case of a print tool, or an electronic link (i.e. “Please click here to consult the Product Monograph…”) which directs the user to the Health Canada Drug Product Database. As a courtesy, please note that the shorter link below (valid at time of post) would be acceptable:
English TMAs: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
French TMAs: https://produits-sante.canada.ca/dpd-bdpp/index-fra.jsp
706
Can sales representatives provide information on a drug's reimbursement criteria in response to a question from a HCP if the reimbursement criteria are not aligned with the TMA. For example, the approved Health Canada indication is for use as 2nd line therapy but the drug is only reimbursed for use in 3rd line. Could the sales representative respond to the question and provide information on reimbursement if not aligned with the TMA. Thank you.
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View Answer [+]
While verbal correspondence between the sales representative and the healthcare professional does not fall under the PAAB scope of review, it is a promotional activity and as such it is subject to advertising regulations. Per section C.08.002 of the Food and Drug Regulations, promotion of a drug and/or indication, prior to market authorization is not permitted. We suggest advising sales representatives to direct HCPs to call the manufacturer’s Medical Information Department in response to these unsolicited questions.
705
Can a non promotional website that is not subject to review and is only available to verified Canadian HCPs link to a post-gate landing page for a PAAB approved branded website?
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View Answer [+]
Let’s assume that “non promotional website that is not subject to review” is referring to a 3rd party website that has a verification process in place to restrict access to HCPs. In this scenario there are two main considerations. Is there an issue linking the branded/unbranded website and is it acceptable to bypass the gating mechanism on the branded website. With respect to the websites, the unbranded website content would need to be acceptable in the context of the brand product, otherwise the link may contravene advertising regulations. With respect to the gating mechanism, if the unbranded site has a valid verification process in place, the HCP is not required to validate their identity a second time. However, keep in mind that the HCP must be directed to the landing page with the respective fair balance copy to ensure they are exposed to the appropriate level of safety information.
