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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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.
