157
Under what conditions / what is the criteria in which a pharmaceutical company is required to report an adverse event in the social media sphere?
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Voir réponse [+]
Please refer to the Health Canada policy document "Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products". The following excerpt applies specifically to events described on internet sites (including social media sites):
- MAHs [Market Authorization Holders] should regularly screen Web sites under their management or responsibility for potential AR [Adverse reaction] case reports. MAHs are not expected to screen external websites for AR information. However, if a MAH becomes aware of an AR on a website that it does not manage, the MAH should review the case and determine whether it should be reported.
- MAHs should consider utilising their websites to facilitate AR data collection, e.g., by providing AR forms for reporting or by providing appropriate contact details for direct communication. Cases from the Internet should be handled as unsolicited reports. For the determination of reportability, the same minimum criteria (i.e., identifiable reporter, identifiable patient, suspect product and AR) should be applied as for cases provided via other ways. If the minimum reporting criteria are met and the report is considered relevant by a qualified health care professional from the MAH, the case is considered "reportable" and must be forwarded to the MHPD in accordance with the Regulations
The entire document can be found here.
156
Could a competitor product monograph or clinical study be used by sales reps during a call to answer a request? The info would be 'on label' and it would be for an unsolicited request (used reactively).
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Voir réponse [+]
The proposed activity is not advisable. These types of unsolicited requests are best handled through the company's medical information department.
Although original research articles having undergone publication and peer-review are exempt from PAAB preclearance when they are not modified/annotated in any way, the context in which they are used may still render them to be "advertising" (and thus subject to advertising regulations). For example, drug representative dissemination/presentation of such articles containing content pertaining to pharmacotherapy would create an advertising context. This is true even if the documents are used by the drug representative only upon unsolicited request. As such, the pharmaceutical company should ensure that neither the activity (i.e. discussion) nor the references contravene advertising regulations. For example:
- Content distributed about the Market Authorization Holder's product must be on label.
- Content distributed about the competitor's products must not be disparaging (e.g. a selective/unfair attack).
- Content pertaining to comparisons must be based on well-designed head-to-head, adequately blinded, RCTs.
Market authorization holders are generally not in the business of promoting their competitor's products. It is therefore likely that the selected competitor literature would discuss the competitor's safety issues or failed efficacy endpoints. Note that this would be considered an unfair attack (as it is a selective presentation of negative attributes of a competitor outside of the context of an acceptable side-by-side comparison versus sponsor's product). The content/activity would therefore contravene the advertising regulations. Market authorization holders should promote their products on their own merits rather than by selectively presenting the shortcomings of competitors.
We do not anticipate issues with simply distributing a competitor's product monograph in its complete & unedited form through the drug representative (i.e. no highlighting/underlining/summarizing). Ensure that it is the most recent version. But detailing about a competitor's shortcomings using their product monograph would contravene the advertising principles stated above regarding selective/unfair attacks. This is again true even if it is done in response to an unsolicited request.
Please call the PAAB office if you have any questions.
155
In the PAAB code 6.6(d), you note a few examples of what would qualify as PAAB exempt. Working within the parameters of drug name only not linked to therapeutic message, would saying that your brand has "no generic equivalent" be appropriate?
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Voir réponse [+]
A section 6.6(d) exemption from pre-clearance review needs to meet BOTH of the following requirements:
- The ad contains only the drug name
- The ad is not linked to a therapeutic message in any way (e.g. the ad does not appear in proximity to an article on a disease for which the product is indicated)
The intent of section 6.6(d) is to allow for the expedient communication of non-comparative, commercial messages. These include changes in availability, price and formulary coverage. Please note that while these items may be exempt from PAAB review, they may still be defined as "advertising" according to the Food & Drugs Act and therefore should adhere to the principles of the PAAB Code.
With respect to your specific question, the proposed claim, "no generic equivalent", neither meets the first criteria listed above nor does does it match the examples listed in the explanatory notes. In addition, it is inherently comparative in that it refers to competitors (or lack thereof). Therefore, the claim is not exempt from PAAB review. Please call the PAAB office if you have any questions.
154
Can you confirm if competitor names can be used as keywords for a branded Paid Search campaign?
This would not go beyond the name/price/quantity restrictions of the branded drug or competitor, and would be no different than placing a branded Ad next to a competitor Ad in a publication, for example.
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Voir réponse [+]
Competitor names cannot be used as keywords for a branded Paid Search campaign. Section 6.5.3 of the PAAB code states:
- Sponsors should not provide the text of a meta data descriptor that contains direct or implied product claims to a search engine. Such items should be sent to the PAAB for preclearance review. Keywords and other meta data tags that refer to competitor products are prohibited.
Please call the PAAB office if you have any questions.
153
Can a pharma company place a product ad adjacent an editorial article in a healthcare journal if the article relates only to discussions about the condition that said product is labelled (no specific drug treatment mentioned)
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Voir réponse [+]
I'll assume from the question that the editorial piece contains only disease information with no mention of drug therapy (e.g. no product or class/category). I'll also assume that, in this scenario, the pharmaceutical manufacturer intends for this adjacent positioning to occur. Note that the context would essentially link the disease article to the product promoted within the adjacent ad. With this understanding, the following scenarios come to mind:
In a healthcare professional publication:
This adjacent placement may be acceptable. The disease messaging would need to be consistent with the constraints imposed by that product's Terms of Market Authorization (e.g. product monograph) for that specific disease/condition. For example, if the product is indicated only for mild to moderate hypertension, the ad should not be placed next to a disease article about severe hypertension or the complications associated with hypertension such as heart attacks and strokes. Additionally, the product ad should prominently disclose indication & risk information relevant to use of that product for the adjacent disease/condition. The PAAB would ensure these requirements are met during review of the branded piece (i.e. clients should inform PAAB of the intended context during the review and include the editorial article - or anything known about the article - within the submission).
In a healthcare consumer publication:
- If the product appears on schedule F (i.e. a prescription product):
This adjacent placement is not acceptable. This linkage would contravene section C.01.044 of the Food and Drug Regulations for a prescription drug (as the combined entity would exceed name, price, and quantity). The PAAB offers an advisory pre-clearance service for DTCRx advertising. See the PAAB website for details (www.paab.ca).
- If the disease article pertains to a schedule A disease AND:
- the product is indicated for the treatment of that disease:
This adjacent placement is not acceptable. As per section 3 of the Food and Drug Act, neither a prescription nor a non-prescription product can be promoted for the treatment of a schedule A disease. This linkage would therefore contravene the regulations for consumer advertising.
- the product is indicated & promoted only for the prevention of that schedule A disease:
This adjacent placement may be acceptable. As per section A.01.067 of the Food and Drug Regulations, the non-prescription product (e.g. vaccines) linkage may be permissible. Note that the disease article needs to be consistent with the constraints imposed by that product's Terms of Market Authorization for that specific disease/condition. Additionally, the product ad should prominently disclose indication & risk information relevant to use of that product for the adjacent disease/condition. The PAAB offers an advisory pre-clearance service for DTC vaccine advertising. See the PAAB website for details (www.paab.ca).
Please don't hesitate to call the PAAB office if you have any questions regarding this matter.
152
As per Question #150, can we make a Quality of Life (QoL) claim based on a published peer reviewed study (condition/use on label) when there is no QoL data in the PM?
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Voir réponse [+]
The QOL data is not necessarily required to appear within the product monograph. The PAAB can consider a QOL claim based on a statistically significant improvement (versus an active or inactive comparator)observed in a published and peer-reviewed study which is blinded, randomized, controlled and designed a priori to measure this endpoint. The wording of the QOL claim should precisely reflect the endpoint which was measured. Also note that the indication will be considered in our assessment (e.g. some indications are limited to specific outcomes). Please call if you have any questions.
151
If a pharma company sponsors a direct to consumer information (DTCI) site for Disease Awareness, can it talk about therapies (if they are all discussed equally, both drug and non-drug therapies)?
I believe this to be "Yes". Assuming that, can the site also link from the therapy descriptions to branded drug websites as long as it handles all treatments equally?
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Voir réponse [+]
The answer to the first question is "yes" provided all requirements in the consumer brochure section of the Health Canada policy document "The Distinction Between Advertising and Other Activities" are met.
We advise against linking various product websites even if this is done in an equivalent manner for all products.
Note that:
- The landing pages on the gated product sites should not be linked to the therapeutic content in the consumer brochure and vice versa. The linkage can be problematic on multiple fronts. For example:
- With respect to the product site landing page: this linkage would exceed the name/price/quantity restrictions of the Food & Drug Regulations section C.01.044 (as the consumer brochure will discuss the therapeutic area).
- With respect to the consumer brochure itself: This would link it to reminder advertising (i.e. the landing page prior to the gate). This linkage would compromise the "non-advertising" status of the consumer brochure. According to the Health Canada linkage principle, when advertising is linked to non-advertising, the combined entity becomes advertising.
- This could confuse consumers as they will keep clicking onto these links only to get to landing pages which don't allow them to go any further than the barrier.
150
In 3.1 you state claims must be consistent with,and within the limitations of, the Health Canada Terms of Market Authorization. I assume "consistent with" means similar to or paraphrasing what is in the PM. What "limitations" of the TMA are you referring to?
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Voir réponse [+]
"Within the limitations of the ...TMA" means not extending beyond any of the restrictions imposed by the TMA (for example, if the TMA limits efficacy to a specific population, the marketing messaging should not imply otherwise). If you would like to talk about other examples, please call me at the PAAB office.
149
We want to download our PAAB approved detail aid on an electronic pad for our reps to use. If there are no changes to the detail aid, do we need to re-submit to the PAAB?
Second part is if the PAAB approved detail aid on the electronic pad has some interactive features such as animation of some charts or graphs do we need to re-submit it to the PAAB. If yes, in what format would it be submitted?
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Voir réponse [+]
In answer to the first part of the question: Resubmission is not required when there are no changes to the copy/flow/layout and no new links or interactive elements are added.
In answer to the second part of the question: The electronic detail aid will need to be resubmitted as the interactive additions to the piece require review. If possible, the entire electronic detail aid should be submitted via script or screens shots with any changes, additions, deletions hightlighted on each page/frame/slide. Once English copy is approved we will need to see the finished product on a DVD to see the interactive elements. This piece should be created in .mov, .wmv or .swf file format and can only be uploaded to the efile system if it is 20mb or less in size. If the size is greater, you can ship a DVD to the PAAB office or we can download it from an FTP site if you have one. If you have additional questions, please contact Laurie Johns at PAAB.
148
Can you provide an opinion on the use of reprints with information containing both within indication information and information outside of indication. The example would be a review article that has both, yet the direction to the sales force would be to highlight and promote the medical issue and the information consistent with the product's use and indication.
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Voir réponse [+]
It is our understanding that "use" of reprints refers to their distribution as part of the promotional mix. As per PAAB code section 3.1, reprints containing off-label content about drug therapy should not be distributed in a promotional context (e.g. through drug representatives). PAAB regards "off label" as content that is not supported by nor consistent with the Canadian Terms of Market Authorization (TMA). We would need to look at the study content (e.g. study population, dosages used, evaluated outcomes) in order to determine whether these parameters are in-line with the TMA or "off-label". Ask for an official PAAB opinion if you are unsure whether the paper is aligned with the product monograph. Drug promotion is regulated under the Food and Drugs Act; however, it is important to note that not all forms of distribution of reprints are considered promotional. Please refer to the Health Canada policy document "The Distinction Between Advertising and Other Activities". The
section "Reference texts, Peer-reviewed Journal Articles" outlines the requirements for the distribution not be considered promotional. Your question mentions an example involving a review article. Note that these secondary references are not generally considered to meet the PAAB Code's standards for evidence for product claims (PAAB s3.1.1). As such, the published & peer reviewed paper should not be distributed in a manner directing the health care professional's attention to claims within the reprint in any way (e.g. through highlighting, insertion of sticky tabs, adding copy/summary or word of mouth). Finally, if distributed by drug representatives (or in any promotional context as per your question) the paper should not be off-label.
Please call me at the PAAB office if you have any additional questions on this matter.
