187
What type of guidance is there regarding the inclusion of product pipelines in Canadian corporate websites?
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Voir réponse [+]
Promotion of a drug prior to market authorization would contravene Section C.08.002 of the Food and Drugs Regulations). Note that one also needs to consider the consumer regulations as corporate sites are open to the general public. Given these two considerations, it is critical to ensure that the activity is not promotional. Please refer to the Health Canada document "The Distinction Between Advertising and Other Activities".
The following guidance is particularly relevant to this specific question:
- the content should be directed to shareholders or potential shareholders. On a website, this could be achieved by including the content in the "Investor Information/Relations" tab.
- the content should be limited to the name of the drug and its proposed therapeutic use (e.g. chemical x for condition Y is in phase II studies).
- no statement can be made regarding the degree of safety or efficacy expected and no comparisons should be drawn with other treatments.
- the document should not be emphasized and it should be devoid of promotional statements
- the content should include a prominent disclaimer that the products have not been approved.
186
Dear PAAB, I'm reviewing a Dear healthcare professional letter to anounce a new packaging of a product. the letter is one page but our standard balancing information in arial 10 font is one page and a half, which is longer than the actual anouncement. I was wondering if it is acceptable to keep the indications contraindications and serious warning and precautions only du to the size of the anoucement. thank you very much for your assistance!
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Voir réponse [+]
The overall presentation of information in any ad must not convey a deceptive impression of the risk or benefits of a drug. The cumulative balancing content required in an ad to avoid such deceptive impression is determined by the interplay between multiple distinct variables. Specifically:
- product-related variables: such as the product's Federal schedule and the risk profile conveyed in the Terms of Market Authorization, AND
- variables related to the ad's marketing claims of benefit: such as their general type, and the number/comprehensiveness of claims requiring specific balance that would otherwise not be required in the ad
Given these variables, we would need to assess the ad and the product's Terms of Marketing Authorization in order to answer your question. Please call me at 905-509-2275.
185
Can a cover tip ad cover the complete front cover of a medical journal? If not, what is the max. percentage?
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Voir réponse [+]
The PAAB does not rule on the maximum size of cover tip ads. Contact the publications as they may impose such restrictions.
184
Do different guidelines exist for promotion of OTC brands to health care professionals with respect to the following:
- comparison of different products based on the approved labelling for parameters such as indications, and the non-clinical claims such as taste,color, odor, dissolution. Section 5.10.2. of the code does not distinguish between Rx and OTC brands.
- use of ASC approved consumer taglines for the brand in APS that will be used with healthcare professionals.
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Voir réponse [+]
No. Audience is an important determinant of advertising regulations. All elements of an ad directed to healthcare professionals are reviewed by PAAB within the provisions of the PAAB Code of Advertising Acceptance (e.g. taglines, non-clinical comparisons, and so on). OTC advertising directed to the general public is reviewed either by ASC or MIJO within the provisions of the Health Canada guidance document "Consumer Advertising Guidelines For Marketed Health Products".
183
Why is it that medical devices do not undergo the same scrutiny (PAAB approval) as prescription medications with regards to promotional tools?
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Voir réponse [+]
The scope of the PAAB code currently excludes healthcare products approved by Health Canada as medical devices. The MEDEC Code of Conduct applies to such advertising. You can send complaints on medical device advertising to Health Canada. Use the following contact information:
Drug Compliance Verification and Investigation Unit
Tel: (613) 952-9906
Fax: (613) 954-0941
E-Mail: DCVIU_UVCEM@hc-sc.gc.ca
182
I am hoping that you can help provide us some guidance with respect to the use of "Now on Formulary" stickers. It is our understanding that such stickers are exempt from PAAB review as long as they are not linked to a therapeutic message in any way as per Section 6.6 d(ii) of the PAAB code. In the past when we have submitted such stickers to the PAAB, we have been asked to provide examples of where a sticker will be placed on previously approved APS. This occasionally becomes a problem when trying to assess viable placement options. For us, the guiding principles have been the following:
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Voir réponse [+]
Modification of existing formulary claims and/or addition of formulary claims to previously approved APS require PAAB review. These changes do not qualify as “FYIs”. Note that the reference requirements on page 1 of the PAAB Advisory document “Provincial Formulary Coverage Statements” apply. Additionally, PAAB requires the previous eFile number(s) and updated layout(s) for assessment. We acknowledge that manufacturers may need to update multiple PAAB approved pieces in order to inform healthcare professionals about formulary changes. Multiple PAAB approved pieces may be included within a single submission provided all of the following factors are met:
- The APS modifications are submitted on the same day.
- Only files within the PAAB approval period can be grouped together in this manner. The modified APS will retain the same acceptance period as the previously approved APS (i.e. a new acceptance number will not be issued).
- There are no changes to the APS other than the formulary claim.
- The formulary message does not include coverage criteria or codes.
Changes relating to coverage codes or criteria must be submitted as separate files.
181
I know that an on-label reprint distributed in a promotional context (ie by a sales representative) needs to conform with the PAAB Code, but does it need to undergo PAAB review?
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Voir réponse [+]
Dissemination of full, unedited articles from medical or scientific journals whose peer-review was steered by the publisher's editorial board are exempt from PAAB preclearance (PAAB code s6.6).
As you've already identified in your question, the advertising regulations would still apply due to the promotional distribution context (i.e. drug reps). Don't hesitate to request a written opinion from PAAB to obtain an independent assessment of whether distribution of the reprint in this manner is aligned with the advertising regulations. Visit www.paab.ca for the fee schedule.
Note that materials written or edited by an employee or agent of the pharmaceutical manufacture should be precleared by PAAB.
180
Could an online-only textbook (such as CCO InPractice) meet the requirements to be used as a reference for the PAAB? It is accredited for education by the AMA and is third-party to the drug company.
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Voir réponse [+]
Generally, an independently published, authoritative textbook is an acceptable source for disease information whether it is in print format, electronic format, or both. Authoritative means recognized by a medical academic institution or bona fide medical organization that provides education. For assessment of specific sources, feel free to submit a written opinion.
179
I have a Patient Instructional Video for an Injectable Therapy. It has video footage that was developed originally in the United States and shows a Sharps Container that is Red in colour. In Canada, sharps containers are yellow. We would prefer to use the same footage for Canada. Is it acceptable to use a disclaimer in the video that states "In Canada, Sharps Containers are Yellow in Colour"?
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Voir réponse [+]
Yes. But the disclaimer should be prominent to avoid confusion. Note that the video requires PAAB review under section 6.4 of the PAAB code. Please call the PAAB office if you have any questions.
178
Does an ad for a medical imaging contrast agent need to be PAAB approved?
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Voir réponse [+]
Yes. The Code applies to all healthcare product advertising directed to healthcare professionals. This includes products for in vivo use in the diagnosis of disease/disorder or abnormal physical state. PAAB code section 1 describes the scope, section 11.3 defines healthcare products within the context of that scope. Also see PAAB code section 6.6 for exemptions.
