77
Can we use American guidelines to complement or supplement Canadian guidelines in promotional pieces? Often guidelines may have slightly different recommendations or one maybe published later than the other.
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Voir réponse [+]
You can generally use valid, published American guidelines to add further support to statements from the published Canadian guidelines. In such cases, the spirit should be to show that the consensus sources are in agreement. We also often permit American guidelines when there are no Canadian guidelines for that specific therapeutic area. We do not, however, consider American guidelines when they are inconsistent with the Canadian consensus. Statements taken from guidelines and used in advertising must be based on good evidence and consistent with the Terms of Market Authorization (s3.1). The PAAB encourages companies to distribute the complete published guideline and it should be the most recent available.
76
Can you please clarify if there are any differences in terms of the PAAB review of an NOC/c product vs a product with full NOC?
75
I am wondering if PAAB rules allow pharmaceutical companies to run a contest for a consumer product of low value on a gated professional website? Eg. run an online ad asking doctor's to submit their own tagline for an ad and win a basket with $50 worth of products in it? If you need more detail, please give me a call.
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Voir réponse [+]
It depends on the nature of the pharmaceutical product. Non-prescription and natural health product companies have successfully run contests of this nature in the past. The PAAB recommends that prescription drug manufacturers follow the Rx&D Code of Conduct section 11 with respect to special promotions and giveaways. If the contest is run often, you should consider the "inducement of prescription" factor.
74
When a new company purchases an existing brand with existing PAAB approved marketing materials, do we need to resubmit those materials if the only changes relate to corporate ownership and the replacement PI?
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Voir réponse [+]
You do not have to submit the files for a review unless the twelve month clearance period has expired. The PAAB does appreciate receiving notification that the brand has changed ownership in case we receive complaints about the advertising. Beyond the scope of the PAAB Code, you would have to respect legal requirements of declaring proper ownership on the advertising pieces.
73
What is the policy and scope of a PAAB review for Canadian-based websites by manufacturers to support their prescription drug products? Is there a required/preferred review cycle - such as one a year? How does PAAB assess information on the website that is outside of the Product Monograph per se (i.e. - information on the disease state, practical tips for patients managing/coping with their disease apart from drug therapy, links to other websites like a medical association's guidelines)?
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Voir réponse [+]
Start with knowing that "Advertising" is regulated information. The definition of advertising includes any means to promote the sale or disposal of a drug. Therefore, if the content of the Canadian-based pharma company sponsored web-site is information that promotes the sale or disposal of a drug or drugs, it would be considered "advertising" subject to the scope of the PAAB Code of Advertising Acceptance (see sections 1 Scope and 6.5 Internet). All Advertising/Promotion Systems (APS) are given a 12 month clearance period subject to a renewal review if the sponsor wants to promote with it beyond 12 months. If parts of the web-site content are changed in any way, a review of that new content is required. The PAAB analyzes all content with respect to the context of the drug therapy being promoted in the APS being reviewed. If disease information that is not part of the approved indication is included in an APS that is drug therapy focused, then the piece will be rejected (see code section 3.1 and 7.6). Otherwise the PAAB review does not look at the quality or reference source of information that is not drug related or is not in a context that includes drug therapy i.e. the PAAB does not review the quality or validity of exercise or food that may be included in the APS. The PAAB reviews links to other web-site information for the validity of it being a reference for drug therapy both in quality and regulatory compliance (within product monograph).
72
In order for a prescription to be filled for product X, the doctor must submit a form which will function as the prescription to a 3rd party distributor. the form also includes the patient's signature which allows the patient to request the 3rd party company to research the patient's insurance coverage for product x on their behalf.
There are no product claims on the form (no efficacy, no safety, nothing). Only the doctor receives the form (the patient can not get it any other way then when the doctor makes the decision to Rx the drug for the patient).
The drug is restricted to a very specific indication; therefore the form includes the specific diagnosis code to allow the 3rd party to ensure that the drug is no prescribed off label.
The form is a strictly administrative document, the pharma company never has access to any of the specific information (no doctor names, no patient names etc...).
Am I correct in my conclusion that this would not need PAAB review?
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Voir réponse [+]
We would require more information in order to provide a complete answer e.g. Who is the third party distributor? Are there any other suppliers for the drug? Who is creating and providing the formsÂ…? Please feel free to contact the PAAB office directly with your question.
71
As per 6.6d and the exemption of "now on provincial formulary", does this apply to a change in formulary status? As an example "Product Y has a new formulary status". This is of course would not be linked to a therapeutic message but is intended to inform the audience of a change in formulary status. Would such a mention be PAAB exempt?
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Voir réponse [+]
The exemption would still apply given that it remains a "formulary announcement" not linked to any therapeutic message. However, the example that is cited would be unclear as a stand alone because the 'new status' is not well defined in the message and may cause confusion.
70
The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article?
Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 and on instructions for use or use limitations8 may be acceptable as side-by-side presentations and in text form.]
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Voir réponse [+]
The PAAB Code (s3.1.1) does not regard "review articles" as high level evidence to support a drug specific claim because they reflect an opinion/ summary from an author rather than actual findings of a primary study. This also applies to non-clinical claims.
69
The CFPC has reviewed and approved a program for Mainpro-M1 credits and is awaiting final accreditation by the College's provincial chapter. Are materials used within the program (e.g. Slide Kit) exempt from PAAB review in the following cases:
- Case 1 - Distributed to participants at the accredited event or at a later date?
- Case 2 - Distributed to non-participants by sales reps?
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Voir réponse [+]
Case 1 - Materials would be considered exempt from PAAB review only after the program has received final accreditation (i.e. once you have received approval for the statement "This program has been accredited by The College of Family Physicians of Canada, and the _____ Chapter, for up to ___ Mainpro-M1 credits"), and the distribution is restricted to registrants of the event (at the event or at a later date) (see Code section 6.6a1). You should also consult the Rx&D Code of Conduct.
Case 2 –If materials are to be distributed after the event to non-participants of the event by a sponsor company, and product or therapeutic claims, comparative data or statements regarding the sponsors products are included, the complete document must be submitted to the PAAB for review (see Code section 6.6a2).
Relevant PAAB Code sections:
6.6(a) 1 Materials that are created by the academic organizers of accredited Continuing Education events/activities may be distributed at the event or to the registrants of that meeting at a later date.
6.6(a) 2 If materials are to be distributed after the event to non-participants of the event by a sponsor company, and product or therapeutic claims, comparative data or statements regarding the sponsors products are included, the complete document must be submitted to the PAAB for review. The respective roles of the authors and the sponsoring pharmaceutical company must be stated clearly on the title page.
68
What is the Canadian specific definition for "off label" regarding reprints? FDA in it's draft guidance Good Reprint Pratices refer to indications and treatment regimens. PAAB code section 3.2 indicates material "must be consistent" with the indications, dosage regimens, efficacy and safety information information in the Cdn TMA. If the article is not specifically listed in the TMA, does it automatically be become "off label"?
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Voir réponse [+]
PAAB regards "off label" as a claim that is not supported by nor consistent with the Canadian Terms of Market Authorization (TMA). A study that is not listed in the TMA is not automatically "off-label". We would need to look at the content of the study (e.g study population, dosages used, approved indication) in order to determine whether these parameters are in-line with the TMA or "off-label". ( See PAAB Code section 3.1)
