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: 1. Did the code change regarding the mention of ongoing trials? 2. Can you describe or give an example of a non-promotional context (unbranded material?)? Thank you
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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.
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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.
Ongoing Clinical Trials for investigational molecules
Hi Jennifer - As a follow-up to Q#223, can a branded APS contain a list of ongoing clinical trials for the approved product in combination with other investigational molecules? There would be no prominence on the unapproved products per s3.2.3, and disclaimers clarifying unapproved molecules/indications.
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Ongoing Clinical Trials for investigational molecules
Hi Jennifer - As a follow-up to Q#223, can a branded APS contain a list of ongoing clinical trials for the approved product in combination with other investigational molecules? There would be no prominence on the unapproved products per s3.2.3, and disclaimers clarifying unapproved molecules/indications.
Hey @alee
No. There can be no mention of unauthorized products/investigational products as they have not yet received terms of market authorization. The discussion of ongoing studies is to demonstrate the company’s commitment to additional research of approved products.
