73 - What is the policy and scope of a PAAB review for Canadian-based websites by manufacturers to support their prescription drug products? Is there a required/preferred review cycle - such as one a year? How does PAAB assess information on the website that is outside of the Product Monograph per se (i.e. - information on the disease state, practical tips for patients managing/coping with their disease apart from drug therapy, links to other websites like a medical association's guidelines)?
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Start with knowing that "Advertising" is regulated information. The definition of advertising includes any means to promote the sale or disposal of a drug. Therefore, if the content of the Canadian-based pharma company sponsored web-site is information that promotes the sale or disposal of a drug or drugs, it would be considered "advertising" subject to the scope of the PAAB Code of Advertising Acceptance (see sections 1 Scope and 6.5 Internet). All Advertising/Promotion Systems (APS) are given a 12 month clearance period subject to a renewal review if the sponsor wants to promote with it beyond 12 months. If parts of the web-site content are changed in any way, a review of that new content is required. The PAAB analyzes all content with respect to the context of the drug therapy being promoted in the APS being reviewed. If disease information that is not part of the approved indication is included in an APS that is drug therapy focused, then the piece will be rejected. Otherwise the PAAB review does not look at the quality or reference source of information that is not drug related or is not in a context that includes drug therapy i.e. the PAAB does not review the quality or validity of exercise or food that may be included in the APS. The PAAB reviews links to other web-site information for the validity of it being a reference for drug therapy both in quality and regulatory compliance (within product monograph).
