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If we offer samples to physicians, by a 3rd party company, do we need to get PAAB approval of the offer/promotion if it only contains an graphic/image of the brand name, logo, and quantity of samples offered.
There will be no claims made...only this minimal information. Does a PI need to accompany the offer?
A simple sample request form would not require PAAB review provided that there are no additional messages or embellishment such as taglines or claims of merit. However, if it is part of a promotional piece (e.g. detail aid, journal ad), it would be subject to the PAAB review.
As a follow up to Question #45, if the off-label content of a peer reviewed journal article is not the focus and will not be discussed by the rep, can a disclaimer be added indicating that the product should not be used off-label, any off-label content is not applicable in Canada and to refer to appropriate product monographs?
Yes, that would be an option if you meet all of the Health Canada guideline requirements. You can provide it in a complete manner, you should not promote the contents.
This is verbatim from the Health Canada Policy:
"Dissemination of full, unedited reference texts (textbooks, chapters of textbooks), government publications or reprints of published, peer-reviewed articles from medical or scientific journals, that are identified as being provided courtesy of a pharmaceutical manufacturer, may be a nonpromotional activity provided that:
Such material may be considered to be advertising where the aforementioned condition is not met or where other factors indicate that the primary purpose is to promote the sale of a drug, for example:
Can peer reviewed journal article reprints be distributed by sales reps or sent by direct mail if they contain off-label discussion of a drug?
What about textbooks purchased from a publisher (no development involvement by the pharma company)?
No. While published peer-reviewed journals do not require PAAB preclearance review they must meet "advertising" requirements if the purpose of the unsolicited distribution is to promote the sale of a healthcare product. To decide that we would look at the content of the reprint. If there is emphasis on a product of the sponsor of the distribution in the reprint, distributed either by rep or mail, then it would most likely be seen as advertising. Off-label promotion is in contravention of the Food and Drugs Act so all statements in the reprint should also be seen in the approved product monograph.
Independently published textbooks with no emphasis on the sponsor's products are not considered to be advertising when they are distributed in their whole with no promotional elements attached. If the book was mostly about the sponsor's healthcare product, it would be considered advertising and off-label statements would not be allowed.
I support a number of small products which are supported by one sales force. In order to simplify detailing efforts, I would like to produce one detail aid for all the products, with a few pages dedicated to each one.
When it comes to the prescribing summaries, should these be placed together at the end of the detail aid, or with the pages related to that product?
Either option is fine. Another option would be to have loose-leaf prescribing information (PI) for each product that the representatives could distribute on request. The reps could offer the PI at the time of promotion of the detail aid. Code s7.3 says the PI "should form an integral part of the presentation or be attached to it". So it can be loose and accompany the piece. The doctor may choose only those PIs that he or she may want. We can save some trees.
I am interested in producing an empty folder with my product name and logo on the front, PI on the back. The folder is to be provided to representatives with no contents. Reps would have a choice of any currently valid and PAAB approved contents to place inside, the whole package to be left with the physician.
When I submit the folder to the PAAB for review, is it sufficient to explain that the only possible contents will be valid and PAAB approved APS, or is it necessary that I submit with all the possible combinations and permutations of contents?
Am I permitted to submit for review a reprint which I would also like to be available for inclusion?
Declaring that you will only include valid PAAB approved material should be sufficient. Keep in mind that you may be restricted from including Editorial (s7.8) material in a product branded folder even though it was PAAB approved. The PAAB does not require submission of independently published reprints; however if you sent it to us we would tell you if it was acceptable advertising in relation to other requirements of the PAAB code.
The rules are clearly stated in s7.6 Reminder Advertising/Promotion Systems of the PAAB Code of Advertising Acceptance. The code is available on the PAAB web-site www.paab.ca.
Just looking for some clarification on PAAB review of health education material (CME accredited, third party accrediated workshops, etc.). When sent in for review, will PAAB be providing an opinion only, or would it be acceptance of the material under review? Additionally, will existing printed material need to be sent to PAAB for review, or is just newly created material that has this requirement of review? Thanks in advance for the help in answering.
PAAB reviews advertising. See section 1 in the code for scope and s11.1 for the definition of advertising. If the material is sponsored by a manufacturer or distributor of a product and the material appears to promote the sale of the product, it is "advertising". See s6.6a of the code for exemptions of truly independently produced educational material. So, it doesn't matter what you call the material, if it fits the definition of "advertising" the PAAB will review it to approval if that is possible. The PAAB reviews material intended for advertising. I am not sure what the last part of the question means.
At a recent medical conference there was a company display that promoted a disease specific message. There was no product mention and the posters did not go to PAAB, although the imformation clearly introduces a specific message. As per question and answer #39, this would seem to be within guidelines, assuming there was no other promotional material at the booth. The complicating factor is that this company does not have an approved product for the disease state being presented. There is a great deal of discussion and "noise" surrounding their product and when it will be available but, to date, it has not receieved NoC. Is this within guidelines? It appears to be promotion for a product currently undergoing review?
It is difficult to answer this question precisely without all of the facts to see and know. What was the "specific message"? The question I ask is "Are they advertising a particular product?" Advertising is regulated information. Companies can present disease information as long as they don't state or imply that it is linked to a particular product they make if the product status is pre-NOC. If it is pre-NOC, I would not expect to see specific product material to link to. Keep in mind PAAB code section 7.8 does require company-generated editorial ads to be pre-cleared if they fit the requirements such as mechanism of action or discussion of current healthcare product therapy. Company-generated "discussion and noise" about a particular product pre-NOC is considered to be off-label i.e. illegal. The smoke and mirrors approach to get around the law is considered to be unethical. Over 400 pharma industry personnel and physicians in the U.S. have been indicted for behaving that way. I am not aware of that happening in Canada because of the checks and balances we have in our promotional system e.g. PAAB. We do have occasional cases such as your example and we discourage widespread behaviour such as that through our complaint system. We will get Health Canada involved if the PAAB proves to be ineffective in stopping specific pre-NOC cases. remember, if "it appears to be promotion for a product currently undergoing review", it probably is promotion and illegal.
Are we required to send material on disease awareness to the PAAB, even if there is no product metnion? Is there a distinction if it is leave behind vs. non-leave behind (eg, a detail piece on hypertension and the MOA of how a therapetuic class works)?
PAAB Code section covers editorial pieces generated by a pharmaceutical company. That means the piece would not exist without the pharma company's financial involvement. The PAAB reviews editorial pieces where healthcare products are mentioned. See Code s7.8. Therefore, if you are talking about mechanism of action of how a therapeutic class works, and the piece is sponsored by a healthcare product manufacturer, I would say that would require PAAB review because it would be difficult not to allude to the sponsor's product and it would appear to promote the sale of that product indirectly. See Code s11.1 for a definition of "advertising" applicable to the PAAB code. Section 1 describes the scope of the PAAB Code. Editorial pieces about disease awareness that do not mention healthcare products directly or indirectly through class would be exempt from PAAB review. Keep in mind bundling that type of piece with product advertising would make the whole thing "advertising" subject to the regulations. There is no distinction between a leave behind and non leave behind with respect to the requirements of the PAAB Code of Advertising Acceptance.
Regarding Representative distribution of CME Accredited Materials:
Can a program supporter have their representatives distribute or base discussions on CME accredited materials ?
If I look at the these points it is unclear to me if indeed there can be representative involvement if so, at what level? :
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.
In my view, sales representatives sell products so when they use "CME accredited materials" to promote the sale of a product I.e. "base discussions", those materials may become "advertising" under the Food and Drugs Act and the PAAB Code of Advertising Acceptance. One can make an argument that sales reps should be able to deliver material requested by physicians. However, the company has to demonstrate control mechanisms to prevent the reps from detailing. They can detail "CME" materials but then those materials become "advertising" subject to all the advertising rules, not the CME exemption. A good principle to remember is that just because you call something by a chosen name it doesn't mean it becomes that. CME is a non-promotional activity so keep your reps away from CME activity and your company will not be perceived as breaking the rules.
Remember these are "Exemptions from PAAB review" and in some circumstances the item can still be perceived as advertising subject to other provisions of the Code and federal law. Be sure to read all of 6.6(a) . The section about the "Distinction Between Advertising and Other Activities" and see the seven questions to ask to determine if something is advertising. Focus on the left side of the code and you won't go wrong. Ask yourself the question "What is my intent in the distribution of this material". Read the whole section.
remember the content matters. If it does not "focused on or provide emphasis on, the sponsor's product(s)..." it would usually not be considered "advertising" and would be exempt from PAAB review and the code application.
We interpret this section as saying that you have admitted that what you are doing is "advertising" and because your company was responsible for generating the piece through sponsorship it should come to PAAB for review. Just because you say it isn't advertising doesn't make it exempt. Independent production and no focus on the sponsor's drug are key elements regarding the interpretation of whether or not something is advertising.
When in doubt about a particular project, you can ask the PAAB for an opinion. There is no charge for verbal opinions and we charge a fee for written opinions. Give us a call at 905-509-2275.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de
