Yes. 6 months.
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We currently have an APS submitted for PAAB review. We have experienced a delay in the project and we may not be able to respond to the last PAAB letter that we received for another 4-6 months. Is there an expiration on how long an unapproved e-file will stay open within our "Submissions" portal for PAAB to receive a response?
Yes. 6 months.
Health Canada's policy "The Distinction Between Advertising and Other Activities" states that materials emanating from a parent company presented during an International conference would not require PAAB review, provided that they are only used within the confines of the conference and are prominently identified as "not being authorized for sale in Canada". However, when a product presented in a promotional booth is approved in the US and in Canada as well, if: - all the material clearly specifies that all the information comes from the US labelling/Marketing Authorization, and - the target audience is from the US and not from Canada, even though some Canadian HCPs could be attending, will this be still considered as promotional activity in Canada and require a pre-clearance form PAAB?
No. The Canadian advertising regulations (including the PAAB code) do not apply to materials presented at international conferences as long as ALL of the following provisions from the Health Canada policy document “The Distinction Between Advertising and Other Activities” are adhered to:
Note, that the disclaimer must be modified in your case as the product is indeed authorized for sale in Canada. I elaborating a bit on the disclaimer you are proposing in your question. Specifically, I suggest prominently conveying that all the information comes from the US labelling/Marketing Authorization AND that this information is not consistent with the Canadian labelling/Market Authorization.
We are sending an announcement to HCPs informing them that a product is now covered on the provincial formulary and providing the the reimbursement criteria. My questions are: Are we required to include the reimbursement criteria? What level of fair balance is required?
The coverage criteria is required when the advertisement includes details relating to coverage (such as formulary codes or eligibility criteria). Note that the presentation should be complete e.g. inclusion criteria, exclusion criteria, definitions, notes, etc. where applicable. This is indicated in the following PAAB advisory:
For pieces discussion provincial coverage in Quebec, you are required to disclose the criteria in ALL pieces that mention or alludes to the indicated use (even if a coverage codes or details are not provided). This is a request from RAMQ as per the following PAAB advisory:
Lowest level fair balance (and the indication) generally satisfies the safety disclosure requirements provided the stated coverage criteria do not include claims requiring middle or highest level fair balance as indicated in the following document. See the following link for tips on matching the fair balance level to the claim types presented in the piece:
Commercial employee asked a presenter AFTER presentation at a scientific conference why DRUG X has not been included in his presentation. DRUG X has not yet been approved by Health Canada but belongs to the employee's company pipeline. DRUG X efficacy/safety properties have not been discussed. Does this interaction constitutes off label promotion?
The PAAB code applies to advertising materials. The code does not cover questions asked during a live exchange of medical information. Nonetheless, it would appear prudent to instruct your commercial employees not to ask public questions (or provide answers) during sessions involving scientific exchanges of information in order to avoid the perception of promotion. The speaker could be trained to respond with something along the lines of “Because drug X is not indicated for condition Y” if a commercial employee from another manufacturer where to ask this question.
I can’t imagine an issue if the employee asks the question privately after the session (i.e. one-on-one between employee and speaker).
Is it possible to produce a teaser ad for a product? Does this ad need to be disease oriented "Something new in X disease area coming soon" or can a brand name be attached to it such as "Brand X coming soon"? Lastly, does this require PAAB review? Thanks you for your guidance.
The claim “Brand X is coming soon” can only be employed once the product is authorized for sale in Canada. This ad requires PAAB review. Although PAAB code 6.6 has an exemption for the claim “Now available”, this message is different from “coming soon”. Also note that this message is not accepted prior to product authorization as it promotes an unapproved product.
The claim “Something new in X disease area is coming soon” would not be accepted as it points to a new product from the sponsor and thus indirectly promotes a product. Teaser ads prior to product authorization should be limited to messaging similar to “Company XYZ is committed to research in disease ABC”.
I am wondering if we are able to create stickers for our material to indicate that we have formulary however I would like to keep it simple and say something like "Now on formulary (special authorization) in your province" or "...in this province" without specifying the province itself. We would of course only place these stickers on tools where the province has received formulary and we would of course provide PAAB with an FYI as to what tools and where we would be placing the stickers. Is this doable?
For all provinces other than Quebec, you can generate a sticker with this proposed statement. The sticker would require PAAB review. In the context of that review, we can assess the sticker placement.
RAMQ (i.e. for Quebec) you’ll need to include the coverage criteria (assume that there are such criteria). There will also be other requirements unique to the Quebec as conveyed in this link: http://www.paab.ca/Advisory_regarding_use_of_RAMQ_in_APS.pdf
We would like to ask PAAB regarding the interchangeability of the term “starter pack” used to identify a traditional sample pack. Certain products have starter packs specifically designed to initiate patients on treatment and help avoid dosing errors and contain patient educational materials. Our question is whether it is possible to refer to a simple sample pack as a “starter pack” when it is not specifically designed as a starter pack and is not mentioned in the TMA?
This would not contradict the PAAB code specifically. We advise that you check with your regulatory department to ensure that this would not contravene any Health Canada labelling regulations or contradict any Health Canada naming conventions.
Good morning, Can we disclose the name of the company behind an unbranded website, when such is being asked in a specific tweet? Thanks in advance
If any part of the campaign is help-seeking, the company may not be identified to the general public. If you receive a completely unsolicited request for disclosure of the company name from an individual, the request for identification of the company name may be granted in such a way that it is only visible to that particular individual (i.e. not visible to other users). i.e. this is only a response to an “unsolicited request” if the response is only provided to the individual who’s asking the question. This assumes that the individual has not been prompted in some way to ask the question.
Section 3(1) of the Food/Drugs Act implies DTC-A is prohibited for products treating Schedule A diseases. Yet, there seems to be many approved DTC-A campaigns for STDs, Arthritis, etc. How is Section 3(1) being implemented in PAAB practice?
PAAB DTCA reviews are a based on the Food & Drugs Act, the Food & Drug Regulations and the applicable Health Canada guidance documents. The PAAB would therefore question healthcare product advertising open to the general public which indicates that the product is for the treatment of a schedule A disease. Note that there are some nuances here which may explain what you’ve seen. For example:
Can you please clarify why product MOA can only come from the TMA, and not published, peer-reviewed in vitro studies? MOA is frequently characterized post-NOC, particularly for products where ‘the exact mechanism of action is unknown’.
The qualitative description of a product’s action in advertising must be consistent with its current Terms of Market Authorization in order to satisfy PAAB code section 3.1. Therefore, if the MOA info in the TMA is outdated (e.g. because the MOA is no longer unknown), the TMA is required to be updated in order to include that info in drug advertising.
Cocktails: 5:30 p.m.
Dinner: 6:30 p.m.
Panel Discussion: 7:00 p.m.