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36
In your answer to Question #34, you state "If the information is created independently of the company it is usually not advertising."
I can think of clear examples of "text or reference books" that are produced by an independent publisher, but which deal almost exclusively with a single pharmaceutical product. If such items are paid for and distributed by company representatives, even though produced independently, are they advertising?
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View Answer [+]
I said "usually" for a reason and you found an exception. Refer to the Health Canada document "the Distinction between Advertising and other Activities". If the book is primarily about one drug, distribution by sales reps would probably be viewed as a promotional activity because that is what sales reps are paid for. Independently published text books are not required to be reviewed by the PAAB. The content of the book would have to be examined to see if there is a violation of the PAAB Code. This case is similar to distributing clinical reprints that were independently published.
35
At a recent visit to my physician, I ran across a display of disease information brochures (eg, diabetes) branded with a product name in the waiting room. I was always under the impression that this would be considered DTC and that we are not allowed to provide branded disease information to the general public. Can you clarify?
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View Answer [+]
Your example would be considered "advertising" because it links the drug name and the therapeutic use. This would be a violation of the Food and Drugs Act section c01.044. PAAB provides an advisory service to avoid this type of violation.
34
Heatlh Canada has issued a policy entitled "Distinction Between Advertising and Other Activities" which states that " No one factor in itself will determine whether or not a particular message is advertising. Each message must be evaluated on its own merit and other factors may apply."
An earlier response in this forum suggested that if it was a single sponsored publication, it was quite likely to be advertising if it dealt with therapeutics (you used the term "rarely" to describe the incidence with which you have seen non-promotional single-sponsored 3rd Party pieces.)
Here's my question - if it is a single sponsored publication and mentions both the sponsor's and the competitor's products, giving them more coverage than "name, price, quantity", but not creating an impression in the reader's mind of bias, is it advertising? It seems obvious that one person's perception of information distribution "...serves to promote the sale of that product either directly or indirectly" (s11.1) may differ from anothers. And how does pharma or their agents know when when the line from "other activity" to "advertising", based on Health Canada's policy, has been crossed, short of a violation or submitting everything for a review?
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View Answer [+]
Please see section 11.1 in the PAAB Code. It gives the PAAB working definition of advertising. That is what we use for the purpose of the PAAB Code. The health Canada "Distinction ..." Document explains how Health Canada interprets what is "advertising". A company stays in business by selling its products. It invests money into communications about its products to enhance their sale. That is advertising. If the information is created independently of the company it is usually not advertising.
Companies want an ROI on money invested into communications projects. I have not seen many examples of communications created by pharma companies about their products that were not intended to sell their products.
33
Once a journal ad is PAAB approved, are we required to resubmit the approved JA for PAAB approval if the only change that will be made is to the dimension of the JA (eg, from standard to tabloid size)?
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View Answer [+]
You don't have to resubmit for approval if it is just a size change. We do like you to send us a note informing us of the new format for our record. If you change wording or move things around it should be resubmitted for approval. If you shrink the size, remember the minimum type size requirements.
32
To show "risk of event data" for concomitant risk factors does the risk factor have to be specifically worded within the indication or can be elsewhere in the monograph? (ie what does consistent with the indication mean?) As an example, smokers are 30% of the persons within the pivotal trials, the monograph lists no contraindications to smokers and the monograph mentions that smokers were in the trials, can we establish (based on published data) that smokers with high cholesterol are at increased risk of events? ( the events would be consistent with what the cholesterol agent is indicating for).
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View Answer [+]
The subset population should be mentioned in the indication and dosing sections of the PM. Just a mention in the clinical trial section would not allow emphasis on the claim. We could accept a verbatim statement in the same context as how the statement appears in the PM without emphasis.
31
Where can I find good samples of detail aid online?
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View Answer [+]
Advertising of prescription drugs beyond name price and quantity to the general public is prohibited by law in Canada. Therefore, it would be difficult to find such material on an open web-site. Individual companies have password protected sites for promotion to health professionals. You would need a health professional to help you gain access or company permission on an exceptional basis. Also, the Ontario Medical Asssociation is launching their OMD web portal and pharma companies can put promotional detail aids on that site with access being restricted to registered physician members. You can see promotional material on U.S. based pharmaceutical company sites. We cannot speak to the quality of that material because they would not have been reviewed by the PAAB.
30
Can risk data be presented for patients with concomitant risk factors. ie, the product is a statin that is indicated to reduce cholesterol and also CV events in patients with high cholesterol. The registration trial obviously included patients with high cholesterol and other risk factors. Can risk data be presented on patients with hypercholesterolemia and a risk factor within the registration trial?
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View Answer [+]
Risk data for patients with concomitant risk factors can be presented in advertising if those data are consistent with what has been approved in the product monograph (PAAB Code s3.1). In the example mentioned in the question, the PAAB would accept claims related to the cardiovascular events that are stated in the product monograph. If the risk factor in the registration file is specifically stated in the product monograph it can be presented in advertising. Just because a study is cited in the bibliography section of the product monograph does not mean the PAAB would accept all data claims from that study. Get your regulatory folks to include all relevant data claims in the product monograph text, not just a listing in the bibliography.
29
If a non-profit organization is producing patient support materials funded by an unrestricted grant from a pharmaceutical company (who is completely hands off and has no involvement other than funding), are these materials PAAB-exempt?
The materials will be reviewed by a panel of health care practitioners to ensure validity and relevance of the information.
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View Answer [+]
Yes, it would be PAAB review exempt due to the independent nature of the production and assuming the content is balanced and objective. If the content appears to be promoting the sale of the sponsor's product it would be deemed "advertising" subject to PAAB review and the PAAB code. See section 11 of the PAAB code regarding the definition of advertising.
28
I would like to run a print DTC advertizing campaign. The content will be limited to the brand name and a sentence along the line of 'ask your doctor'. No claims will be made. The media used is not targeting any specific audience.
I would like to know:
- if the text has to be submitted
- if the text on the actual support has to be submitted
- which articles of the code I should refer to
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View Answer [+]
DTCRx ads are not subject to mandatory review within the requirements of the PAAB Code of Advertising Acceptance. If the sponsor requests it, PAAB will give an opinion on DTCRx ads based on the Health Canada policy document "The Distinction Between Advertising and Other Activities". The opinion service is endorsed by Health Canada and Rx&D. If you choose to send a DTCRx project for PAAB opinion we would require seeing the layout, graphics and words to be used.
