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155 - In the PAAB code 1.5, 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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Section 1.5 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 1.5 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.
