This appears to be about a specific product and class. We would assess on a case-by-case basis considering the totality of the market. In these instances, we suggest going through the review process.
DTC for OTCs is out of the PAAB Code’s scope. We do not comment on, or endorse, any particular agency in the DTC space for OTCs. The PAAB encourages preclearance of DTC/OTC materials by a Health Canada recognized agency.
There are many considerations which would be assessed during the review process to determine whether this would be acceptable, but in general, the reprint of a PM study that is unedited and complete could be an acceptable downloadable resource on a gated HCP website. It should be disclosed where it will be placed and how it will appear (e.g. Study name? Description? Image?). This would be done as part of the review of the website to ensure that where it is placed for download is acceptable. Just one example of where it would not be acceptable: if the PM only included results of an interim analysis for an NOC/c product, we would question reprints of the final analysis even if they included the interim analysis results as NOC/c products are restricted to presentation of data from the PM only.
We are not aware of additional guidance documents from Health Canada. As a broad concept, you would want to consider if the usable item or experiential event could be seen to have implications for the use of the product which would create a link to therapeutic use. Wifi sponsorship appears low risk where as a claim such as “Concert brought to you by Brand X” for a concert supporting breast cancer, would be problematic. When in doubt, we suggest submitting for DTC opinion
DTC SEO and SEM are subject to the Food and Drugs regulations, the Therapeutic comparative advertising: directive and guidance document and the Interim guidance – Fair balance in direct to consumer advertising of vaccines.
Yes, they may include indication and patient population provided they do not contravene the federal regulations, particularly section 9(1) of the Food and Drugs Act.
No, they may not contain competitor brand/generic/manufacturer names. Please see SEM Keywords PAAB Forum post and PF Q 456.
The PAAB code applies to HCP advertising and patient information. DTC advertising is subject to the Health Canada regulations regardless of the preclearance agency who performs the review. When DTC advertising is used to drive HCPs or patients to a website, it is considered to be a dual audience and may be subject to the PAAB Code and Health Canada DTC regulations. If you are unclear if your tool falls in the dual category space, PAAB can provide an opinion.
The disclaimer is generally requested when any non-clinical features/characteristics extend to/may suggest a clinical benefit. This would include experience claims such as the example provided (# of patients worldwide). The disclaimer is presented to be clear that the number of patients worldwide should not be extrapolated to significance of the efficacy or safety profile of the medication. As a courtesy, the copy “prescribed worldwide” would have to be supported with validated global data which tracked prescriptions to validated new patients.
Hey @NatBourre
As per Q&A 529, “Study findings which are not presented in the TMA (whether because that study is not in the TMA or because the portion of the study in question is not in the TMA) can be considered in drug advertising provided the study meets all provisions in the PAAB code and guidances”. Some elements to consider are that the outcome is consistent with the indication and outcomes presented within the TMA and that the reference is a published and peer-reviewed study which is blinded, randomized, controlled and designed a priori to measure the outcomes. Components of the study which would be considered outside of the limitations of the indication would not be considered.
Hey @NatBourre,
A balanced presentation of the treatment guidelines can be considered in an non-branded APS when there are multiple treatment options either within one category or across multiple categories. The distinction is that there must be more than one drug product featured. If only one drug product is featured, regardless of other branding elements, or even direct mention of the product, the piece would be branded.
The app itself would be reviewed against the standards of the code. While all functionality of the app should be included in the submission, the manufacturer’s legal department should ensure that all Federal and Provincial requirements pertaining to the collection, usage, storage and distribution of patient data are adhered to.