127
On the website: http://fightosteoporosis.ca/ the copyright notice says: "Copyright C 2010 A research based pharmaceutical company"
This doesn't seem right to me, I would expect a copyright notice to clearly state the site's owners. Investigation shows that the site is operated by Warner Chilcott (who market Actonel) but a lot of digging is necessary to get that information.
Is this on-side with PAAB regulations?
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Voir réponse [+]
This is a direct-to-consumer activity that contains a legal issue that is beyond the PAAB Code. Health Canada has a policy, "The Distinction Between Advertising and Other Activities", see http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index-eng.php regarding Help-Seeking ads that you can see on their web-site. As a requirement to meet the law, you cannot identify a company name. Other companies have tried identifying their company through the copyright line and were told by HC that that did not meet the legal requirement. The PAAB offers a four day trurnaround opinion review service for Direct-to-Consumer advertising and disease information web-sites that helps keep companies out of trouble.
126
If a product that has NOC (i.e., without conditions) but does have a black box warning, how prominent do the indication statement and black box warning need to be? We would like to include both in the fair balance section of the piece, but wonder if either text needs to be placed elsewhere in the piece as well.
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Voir réponse [+]
Generally, the black box warning can appear with your fair balance block. Note that this warning must appear within a black box in the ad in order to reflect the PM. Also note that there are situations in which the warning is required to be repositioned. Consider, for example, a scenario in which the black box speaks to the importance of closely monitoring for drug interactions when the sponsor's drug is used in combination with Drug ABC. If the APS in this hypothetical scenario were to contain a claim depicting efficacy results for a protocol combining the sponsor's drug with drug ABC, we would require that the warning appear prominently on the same page as this claim.
Generally, the indication may appear with the fair balance block. However, there are situations in which the indication is required to be repositioned.
For example, the indication should appear near the beginning of the ads at product launch.
For NOC/c products, please refer to the guidance on our website at www.paab.ca
For more specific questions/scenarios, please call the PAAB office.
125
Most brands have quite lengthy balance and we are looking on how to incorporate this into banner ads that include product claims. If the banners are animated and they rotate/transition automatically from claims to balance, is that okay. This would be the same as turning pages in a detail aid....correct?
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Voir réponse [+]
It is acceptable to use Rx banner ads which transition/rotate automatically between claim page and balance page within a gated website. Such banners for Rx products should not be accessible to consumers as this would go beyond the name/price/quantity restriction (FDR C.01.044). Please ensure that the slides rotate at a pace which permits the balance slide to be read within a single rotation. This is important given that fair balance is required to be prominent as per PAAB code sections 2.1.2 & 2.4 & 3.5. With regards to length of fair balance, you can ask the PAAB reviewer whether there are any segments of fair balance which can be removed or revised. This may be possible depending on the product's Terms of Market Authorization and the quantity/type of claim copy. Also ensure that there is a link to the Product Information (PI) or Product Monograph as discussed in Q&A #111. Please call the PAAB office if you have any questions.
124
Can we use the same visual/design for a new product launch that was used pre-NOC in editorial pieces? The visual/design has not been used in other countries or jurisdictions so not linked to any product.
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Voir réponse [+]
Once the product is approved, the manufacturer may continue to use the same visuals/colours from prior editorial pieces in branded APS ONLY if the pre-NOC content falls within the limitations of the approved product's Terms of Market Authorization (TMA). Otherwise, using the same visuals/colours would link the product to disease information which extends beyond the limitations of the TMA thus contravening PAAB code section 3.1 and possibly the Food and Drugs Act section 9.1.
The PAAB urges pharma companies to approach the decision to use future branding elements in pre-NOC unbranded pieces with caution as the final TMA is not known with certainty prior to product approval. It is possible that you may not be able to use visuals post-NOC if they were used in pre-NOC pieces that contained disease information or content which extends beyond the limitations of the final/approved TMA (e.g. due to unforeseen revisions requested for the PM). If the pharmaceutical company is uncomfortable with this possibility, we would advise against using the planned future branding visuals within pre-NOC APS.
Note that use of visuals/designs prior to NOC which already exist in other jurisdictions in association with the brand would appear to be an indirect promotion of an unapproved product. This would contravene section c.08.002 of the Food and Drug Regulations.
See question & answer #102 for discussion on acceptable pre-NOC content and see Q&A #107 for discussion on acceptable references in pre-NOC pieces. Call the PAAB office if you have specific questions about pre-NOC APS.
123
We were wondering whether there are potential issues with using the same patient visuals across both healthcare practitioner and patient materials. The patient materials would be mainly patient information pieces for those who are already on the drug.
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Voir réponse [+]
PAAB Code s. 6.4.3 requires that patient material be non-promotional. The same visuals can be used in branded HCP pieces and branded patient pieces provided that the visuals do not carry a promotional message. PAAB considers context when assessing visuals in any APS and the intended audience is an important part of that context.
When employing the same visuals across several pieces, it is important to be cautious not to link branded and non-branded pieces. Such linkage would inherently brand the unbranded content.
122
If a pharma company with an OTC or BTC product creates a private branded website that is password protected and accessible only by physicians, it is understood that all company generated content on the site would be subject to PAAB review and approval.
However, if the site also allows for user generated content such as discussions between physicians, physician blog posts, or other physician generated questions or commentary, how might this type of dynamic activity and content be viewed by PAAB? Particularly given this type of content would be in constant evolution. Please note that this content would be viewable only by registered Canadian physicians. Any advice or direction would be appreciated.
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Voir réponse [+]
This answer is equally applicable to OTC, BTC, and Rx drugs. Health care professional directed drug advertising (whether prescription or non-prescription) falls within the scope of the PAAB code. In the case of social media websites, the PAAB would pre-clear the framework of the site. The framework includes any content controlled by the sponsor (including but not limited to the landing page, introductory instructions, company controlled drug & disease content, discussion thread titles/topics/questions). Although the PAAB would not require to pre-clear or review the dialogue among registrants, it is important that the sponsor monitors all content on their site including the posts/discussions. Keep in mind that although the manufacturer has forfeited some control over the message by letting the registrant post content, the manufacturer retains the regulatory risk as this is the company's site. For example, the manufacture is expected to ensure that all information on the site is accurate despite the inherent reduction of control by the manufacturer. The need for this sort of moderating can be minimized by clearly conveying site rules at the outset. The degree of restrictions imposed would depend on the manufacturer's comfort level regarding legal liability. Another consideration may be to employ voting functionality instead of open text fields. This would effectively limit the registrant contributions to content which the manufacturer is comfortable with. Alternatively, to reduce the legal risk, the manufacturer can consider simply sponsoring a site created and controlled independently by a third party. This would reduce the likelihood that the content falls in the advertising realm (thus reducing the likelihood that advertising regulations apply to the content on the site). It is important, however, to consider all 7 factors in the Health Canada document "The Distinction Between Advertising and Other Activities" when determining whether something falls within the advertising realm. PAAB can help you with this assessment.
A second important reason the manufacturer should closely monitor the social components of the site is that there is an expectation that the company will report adverse reactions conveyed on the site (provided the reporter, the patient, the drug, and the event are either known or can be determined). Please visit the following Health Canada guidance document for information on adverse reporting requirements for internet sites:
http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2009-guidance-directrice_reporting-notification/index-eng.php
Sections C.01.016 & C.01.017 of the Food & Drugs Regulations speak to the timelines & level of priority towards different adverse reactions. If you do not desire to monitor the site for adverse drug reactions, clearly convey that registrants are not to post adverse drug reactions on the site. For example, there might be an instruction to call the medical/regulatory department instead.
Please keep in mind that the social media area is evolving. For the most current guidances, call the PAAB office. Note that many of the regulations for internet advertising apply to the social media arena. Please see PAAB code section 6.5 regarding internet advertising.
121
Our understanding is that not every tool needs to include extensive fair balance, but that the fair balance content can be determined by the number and weight of the claims in the piece.
If we are submitting a dosing calculator which has no other claims other than dosing information, how would we determine which fair balance text could be eliminated? Our thought would be to include the indication statement and contraindications. Would that be enough? This is for a product that has NOC (i.e., no conditions).
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Voir réponse [+]
For clarity and completeness as per PAAB Code 2.1 & 2.1.2, the APS should state the product's indication and the associated limitations. As for the fair balance requirement, we would need to see the APS in proper context (with visual and text) in order to determine what balance copy is necessary. Keep in mind that fair balance requirement is based on the number and type of claims in addition to the product monograph. The following are examples of elements which may still be required in an APS containing no claims other than dosing information:
- contraindications
- boxed or bolded warnings/precautions
- dosing limitations or important safety information relevant to dosing (e.g. special populations)
Please note that the prescribing information (PI) would also be required to accompany this piece as per PAAB Code s7.2 & 7.3. Please call the PAAB office if you have questions about the fair balance requirements on a dosing calculator for a particular product.
120
We are considering producing a patient brochure in an alternate language other than french or english that remains valid until mid 2010 by PAAB. I understand that PAAB does not require a review if this is simply a translation and printing however in the last two months the Merck logos and trademarks have changed.
If we change the trademarks/logos on this brochure do we require an additional review seeing as we are only changing the logos to reflect the new company name and then printing this new language which would have the same mid 2010 expiry date. Content of the brochure will not be changed.
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Voir réponse [+]
The PAAB should be kept aware of the current version of the ad. However, a change in corporate logo or trademarks would not necessitate a new review. We suggest sending the change as an "FYI". This can be done by attaching the updated piece to an email referencing the original PAAB file number. The email should be sent to review@paab.ca. We will upload the updated piece into the appropriate eFile for our records. Please note that an approval response will not be provided as a full review will not be conducted. The approval expiration date for the piece will therefore remain unchanged.
You are correct that the PAAB performs reviews in English and French. APS produced in other languages that are translated from a PAAB approved APS should not carry the PAAB logo and may include a disclaimer stating the item was translated verbatim from a PAAB approved APS.
119
Does regulatory permit placing a link on an unbranded condition website that drives visitors to the associated corporate website? The link would direct users to the corporate home page.
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Voir réponse [+]
The link to the sponsor's corporate website can appear on an unbranded condition website. The PAAB would not require to review the link provided that it directs the browser to the home page. Note that the unbranded condition site requires PAAB review if it discusses drug therapy (regardless of whether the link appears on the site). It would be reviewed under PAAB code 7.6. Please call the PAAB office if you have any further questions about this.
118
Under what circumstances would it be acceptable to use a peer-reviewed, published study for a schedule F drug if that study uses a dosing regimen for the companion drug (always prescribed together but not subject of advertising, nor manufactured by the same company) that is inconsistent with the product monograph?
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Voir réponse [+]
Advertising must be consistent with the sponsor product's Terms of Market Authorization as per Food and Drugs Act section 9.1 and PAAB code section 3.1. As such, products promoted for use in combination with the sponsor's drug should be within the sponsor's product monograph (PM). Additionally, the dosing of that combined drug should be consistent with the PM. Please call the PAAB office if you would like an opinion on your specific case.
