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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
573

Hi, Is it allowed to develop a tool for physicians that will be used with a patient to help the patient make the decision to use a specific therapy? if yes, should the information in this tool restricted to Part III of the PM only or other sources are also allowed? Thank you!

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572

As part of our initial approval for a drug, we currently have an indication for the treatment of condition X. An additional trial has been published for cancer patients with condition X. The dosing remains consistent with the initial TMA. Can we promote our drug for cancer patients with condition X?

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571

Are Naturopathic Doctors included in the definition of 'health care practitioners' when determining whether promotional material needs to be reviewed by PAAB?

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570

Hi, We would like to highlight specific market data for our brand. We seem to fall into the guidelines that PAAB has put together but the specific data we would like to highlight is the new patient share (this consists of naive and switch patients). It would be a "leader" or "#1" claim. This data is from the private payer database (RxDynamics). Is this type of data allowable? I've done leader market claims as it relates to the total prescriptions dispensed but have never tried this type of data. Thank you.

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569

Can you use before and after photos that show a drug's efficacy in a patient brochure?

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568

Questions in regards to provincial formularies: 1. Would providing the name of the "product now on province formulary" statement with the inclusion of the din number for ordering be considered exempt from PAAB? 2. If the link to the complete provincial formulary is included would this be considered the same as including the coverage criteria for the product? 3. Is including the complete provincial formulary link and directing to the section or page for product "X" be considered as providing the coverage criteria and thus requiring PAAB review?

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567

We would like to know if we can make a claim about the % of patients who would recommend a specific treatment to other patients. The % is published in a retrospective study done on patients who were taking this specific therapy. It is a patient reported outcome that is not in the Product Monograph. Please advise if there is any way to put such a claim through.

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566

Hi PAAB, Section 1 of the Code provides that it applies to APS directed to HCPs (as well as patient information distributed via HCPs). Corporate websites target consumers rather than HCPs. However, it seems that PAAB considers corporate websites presenting information on the company's products as corporate APS (s. 7.4 of the Code) that must be submitted to PAAB. Does it mean that the Code also applies to material that does not target HCPs? If the corporate website presents general information on a disease or a class of products, does it need to be submitted to PAAB or would it be considered as DTCI? Thank you.

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565

Could you please clarify the formulary message for the province of Québec. If a company mentions the following message: “Drug X: Now on RAMQ formulary (médicament d’exception code)” and not linked in any way to additional product messages or disease/corporate messages. We would not allude to the indicated use and will add the RAMQ TM. Is the above mentioned text still PAAB exempt or not. Are we in the obligation in Québec to provide code and coverage criteria every time we mention RAMQ reimbursement (then subject to PAAB). I have read the information on the PAAB website, but still having different interpretation/confusion on this. • Memo dated April 15, 2016 - Advisory regarding use of Régie de l’assurance maladie du Québec (RAMQ) in APS • PAAB ADVISORY guidance on Provincial Formulary Coverage Statements • Q 519 in the Ask PAAB section

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564

Based on advisory board recommendations for supportive tools, a company would like to create an unbranded "reference tool" which documents the metabolic pathways for drugs in a particular therapeutic area. This would be a service item distributed by the representatives. Information would be taken primarily from Product monographs and in a few cases, the literature. Is there any reason this would not be allowed? what would be the constraints?

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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Have a great summer and see you in September.