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Removed 07/2018
I am not sure if the question is worded in a manner that was intended. I note "distributed by physicians" and "approved by a national medical society". If no pharma company is involved in the project in any way, the answer is "no". If a pharma company is involved in the sponsorship for production or distribution, it may seen as "advertising" subject to PAAB review if it appears to be promoting the sale of a product.
Does a poster (developed by Canadian pharma company) intended to be used at an international conference need PAAB approval?
Yes, if it originates in Canada and is controlled by the Canadian pharmaceutical company, it is subject to the PAAB Code. You can also see requirements for promotion/information at international meetings in the Health Canada guideline "The Distinction Between Advertising and Other Activities" that is available on the Health Canada web-site.
All claims must be consistent with the Product Monograph. In the past, we have been advised by Health Canada that the inclusion of a study in a drug submission/bibliography section is not indicative of the approval of all parameters of that study. There must be proof of acceptance of the information evidenced by inclusion in the text of the Product Monograph. We can ask Health Canada for a product monograph interpretation. We have no control over when Health Canada answers and they may ask to see the advertising. The PAAB will not release submission information without the written approval of the submitter.
Code s5.11 goes on to say that 'In no circumstances would extrapolation of the claim beyond the actual study be acceptable'. Often, if one does not specify the population (e.g.: men in a cholesterol agent comparison) then the reader might extrapolate the study results beyond the evaluated population. This would be true even if you had 50 studies showing the same result. Important information such as this should not be put in mice-type.
We are getting a new indication that was based solely on a very small open-label study with a subjective endpoint. The study was not mentioned at all in the PM, however, it was published.
We may consider allowing the use of the published, open-label study if they could prove to us that it was the basis of approval. To do this they would have to forward a copy of the S/NDS and any other pertinent correspondence from Health Canada. We could approach Health Canada on their behalf to resolve any contentious issues regarding the acceptability in advertising of their claims related to this study.
Yes, the fax is "advertising" as interpreted by the PAAB Code because you are linking information to the web-site that is drug specific. The purpose appears to be to promote the sale of a particular drug. We note that if the product monograph did not include claims such as CHD mortality, you would be violating federal advertising law. You should not cite a study name that includes a claim that is not within the stated drug's authorized Product Monograph. When in doubt, telephone the PAAB and ask a reviewer your question.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
