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Just saw a tv ad on CANADIAN tv (Sportsnet) for zostavax, referring viewers to zostavax.ca and it very obviously promotes it for prevention of shingles. How is this not a violation of DTCA regs?
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Voir réponse [+]
This forum is intended for discussion relating to general application of the code and regulations. It is not intended for performing reviews of existing pieces. I have not seen the particular ad referred to in your question.
Nonetheless, readers should note that it is permissible to discuss the therapeutic use of Schedule D products (such as vaccines) in DTC advertising IF fair balance is provided. You can refer to the Health Canada Interim Guidance "Fair Balance in Direct-to-Consumer Advertising of Vaccines".
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I have been contracted by CTC Communications to aid in developing an application program on a product for a chronic arthritic condition with a high indication of depression/anxiety in patients. Like most chronic illnesses, the incidence of a mood disorder is high - this has nothing to do with the drugs treating the arthritic condition (i.e. the drugs are not causing or treating the mood disorder). In this program, no claims are made regarding the product (i.e. no claims are made that the drug helps depression/anxiety), it simply offers education and rating scales on depression/anxiety. Does this program need to be PAAB approved? Furthermore, what elements of the program need to be passed through PAAB?
The elements include:
- Content in the application
- Information handout on the application that the representative may leave with the physician
- Paper or e-detail on the application that the representative may use to detail the physician on the application
Thank you for your feedback in advance.
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Hello, I work for a medical communications agency. We were given a restricted educational grant to develop a program which falls under the category (as per Rx&D) 'Other Learning Program'. It follows the CME guidelines but is not accredited. The program sponsor did not have any involvement with the development of the program content. It was developed by the steering committee of specialists. The program is unbiased in nature.
Treatment options for the condition in question are mentioned but not the drugs themselves. The distribution of the program will be via a direct mailer to the target audience that drives the audience to a web site where the program is housed - sales representatives are not involved in the distribution. Please confirm if this requires review/approval from PAAB.
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Voir réponse [+]
Based on the limited information you provided and the fact that we could not see the actual program, we provide the following guidance.
Health Canada, the ultimate federal authority on advertising regulations, employs the Health Canada policy document "The Distinction Between Advertising and Other Activities" to distinguish between advertising and non-advertising. This policy document contains 7 factors which, when assessed objectively, help us determine whether the advertising regulations (including the PAAB code) apply to the materials in question. These factors relate to content, extent of influence, the audience, who delivers the message, whether it is sponsored, the message context, and frequency of distribution.
This program appears to fall in the realm of HCP advertising (and thus requires PAAB review) as it exists due to pharma funding, it relates to drug therapy, it is disseminated to HCPs through a push system, AND the manufacturer appears to have had influence over the content or the creation process (as it was created through a restricted grant). Potential examples of influence include selection of the precise topic, scope of research, the committee members, writers and/or having review privileges. This document would be reviewed as an editorial under PAAB code section 7.6.
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I have been contracted by an agency to help develop a program for doctors on a product for an arthritic condition with a high indication of depression and anxiety in patients. No claims are made in the program regarding the drug. The program simply offers education and tools on depression and anxiety in these patients with this arthritic condition. What are the PAAB guidelines that must be adhered to in this program? Thanks!
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Voir réponse [+]
This sounds as though it is a product branded app. All PAAB code provisions would apply. For example, all content offered through the app (whether treatment or disease related) would need to be on-label for that product.
It's hard to provide more specific information without seeing the specific APP. If you'd like to receive guidance before getting too far into the project, I suggest submitting what you are envisioning for a written PAAB opinion. This is a great way to learn about key red flags while you are still early in the process. The fee schedule for an opinion is on our website. Call the PAAB office and ask to speak with one of our file coordinators if you'd like information on how to submit a request for an opinion.
223
Hi, In the past we produced a branded APS presenting ongoing off-label trials. This piece was reviewed and approved by PAAB. Recently, we looked at the PAAB code and found that mentions of ongoing trials were acceptable in a non-promotional context. We have 2 questions:
- Did the code change regarding the mention of ongoing trials?
- Can you describe or give an example of a non-promotional context (unbranded material?)?
Thank you
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Voir réponse [+]
PAAB section 3.2.3 has not changed. It reads:
"Reference to research or ongoing studies may be made in a nonpromotional context with no prominence on information that has not been authorized by Health Canada. A study involving off-label use, that has been completed or has been presented at a medical meeting, and includes information that is not included in the Health Canada Terms of Market Authorization, should not be mentioned in advertising".
Ongoing trials may be discussed in branded APS in a context clearly conveying that the trials are "ongoing" (and clearly separated from completed studies so as not to confuse the reader). Mention of off-label endpoints should be disclaimed (e.g. "Arbace is not indicated toÂ…"). The PAAB defines ongoing studies as studies which are still within the data gathering stage. It is important to note that once data gathering is complete, or an interim analysis is conducted, we no longer consider the study to be "ongoing" even if data has not been published or made public. The manufacturer must cease distribution of the piece once any of the included studies no longer meet these criteria (irrespective of the pre-clearance period within the PAAB approval number).
The segment "in a non-promotional context" is meant to convey that the tone relating to ongoing study content within the APS must be non-promotional. For example, promotional elements should not be associated with the off-label ongoing studies (e.g. study taglines, or promotional buttons/visuals). Additionally, promotional adjectives such as "large scale", "rigorous", "landmark", "pivotal" must not be used when describing such trials. The presentation should simply convey that the manufacturer is involved in research (+/- a description of that research).
The anticipated completion date of the study may not be provided (as this alerts readers as to when to start looking for the study results). Additionally, an entire campaign based on off-label ongoing studies could be considered to be a violation as such activity could be construed as promotion off-label uses. We therefore advise our clients to exercise caution when considering the frequency of messaging and breadth of formats/media used to discuss ongoing studies.
222
What are the restrictions regarding reporting on efficacy in a clinical trial in our news releases? We will be issuing a news release when we receive NOC. We want to say what improvement in patient health was observed in the trial. The trial compared our drug to placebo. How can we explain what happened?
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Voir réponse [+]
The Health Canada policy document "The Distinction Between Advertising and Other Activities" outlines the requirements for press releases not to fall in the realm of advertising regulations. I'd like to emphasize four provisions which appear to be particularly relevant to your question.
The first three provisions centre on the principle of sticking to reporting the facts which are indeed "news":
- There should be no statement made regarding the expected degree of safety or efficacy. In other words, limit the discussion to the fact that the study is now complete and the results which were demonstrated versus placebo in that particular study.
- Aside from reporting the study results, the announcement should be limited to the name of the drug and its authorized/proposed therapeutic use. In other words there should be no speculation of what the drug's approval or the study's results could mean (e.g. this is a game changer), and no elaboration about previous studies on the sponsor's or competitor's drugs.
- Nothing should imply that the product is a breakthrough.
Additionally, note that a press release should contain no comparisons against other treatments (this should not be an issue in your case as you've noted that this is a placebo controlled study).
Refer to the aforementioned policy for additional requirements relating to the intended audience, appropriate disclosure when the release relates to an unapproved product or unapproved indication, extent of influence on pick-up/visibility, and considerations for products on the Special Access Programme.
Why is it so important that press releases be constructed so as NOT to fall in the realm of advertising regulations? For starters, they can be accessed by members of the general public while the content exceeds that which is permissible in the consumer advertising realm. Additionally, they tend to relate to unapproved products/uses (advertising of which contravenes section 9.1 of the Food and Drugs Act). Finally, as they focus on what is "new", they're unlikely to meet advertising requirements for disclosure of risk information.
221
Reading Q&A section, I understand that advertising to HCPs, although voluntary, falls under PAAB. Where would we go to clear advertising to the consumer? I usually work with food, so it is new for me to work with NHPs and I would like to do this correctly. Thank you.
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Voir réponse [+]
Pre-clearance for healthcare professional (HCP) advertising of healthcare products is voluntary. However, some trade organizations require their members to participate in PAAB preclearance mechanism as a condition of membership. Also note that PAAB monitors the market place and intervenes in response to HCP advertising which does not meet the PAAB code requirements.
In the interest of preserving self-regulation, we'll notify Health Canada when we encounter willful non-adherence to PAAB code provisions which relate to the Food and Drugs Act. The PAAB pre-clearance mechanism is the most effective way to ensure that advertising is consistent with the PAAB code.
In response to your question, the PAAB code applies to healthcare professional advertising and patient information for all healthcare products (whether it be a natural health product, a homeopathic product, a biological, or a prescription product). Both the PAAB and ASC provide advisory opinions for direct to consumer advertising of prescription and biologic products. ASC and MIJO provide preclearance for consumer non-prescription and natural health product advertising.
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A couple colleagues have recently indicated that Annotated Product Monographs are beginning to be subjected to more stringent restrictions by the PAAB. Both indicated that the reason was that by calling out certain elements of the product monograph that it was creating "undue emphasis" on product attributes. This raises two questions:
- How does this differ from a typical sales aid whereby charts and compelling data points are given emphasis and fairly balanced with appropriate safety information, etc. AND
- Doesn't the fact that an annotated Product Monograph contains all pertinent balancing information in one easily accessible tool not by default ensure that appropriate caution was exercised in highlighting data?
Furthermore, is this a recent development? I can recall within the last 2 years working on several of these tools with no such objections from the PAAB. Thanks in advance for your reply!
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Voir réponse [+]
PAAB has created a guideline document for annotated product monographs. It summarizes how PAAB has already been reviewing annotated product monographs. Rx&D is currently helping PAAB review the document. We have not added "increasingly stringent restrictions". You can still use callouts in the margins of the document (I assume this is what you are referring to ). Call me and we can talk about it.
219
Hi Patrick. We're looking to place a card within packs of our prescription product, directing patients to our website. The card will contain no promotional claims. Only content would include: product and company name. Please go to www.xxxxxxxxxx.com Since the piece will essentially be part of the product packaging, I wanted to ask if this would fall under review of PAAB or HC? Also, as there are no product claims, would this be exempt from review? Thanks!
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Voir réponse [+]
Content placed in the product package should be sent to Health Canada for review. No PAAB preclearance is required for such content.
218
Dear PAAB, We are interested in building a small electronic questionanire that reps will use to ask the doctors some questions about how they feel certain things are a problem in their practice when managing their XXX[disease state] patients? The questionnaire would be unbranded, make no mention of any treatments. Would this be considered PAAB exempt?
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Voir réponse [+]
Disease information materials which make no mention of treatment by name, class, or category AND are not linked to healthcare product advertising in any way are exempt from PAAB preclearance. If this accurately describes your questionnaire, it would be exempt from PAAB preclearance.
Note that "disease information" would not include content alluding to drug treatment even if no product/class/category is mentioned. For example, a questionnaire containing questions like "Have you noticed that your patients have adherence issues with medications that are dosed more than once per day?" would not be exempt from PAAB preclearance.
Although not directly related to your question, it should also be noted that market research materials meeting all provisions outlined in chapter 17 of the 2012 Rx&D code do not require PAAB review.
