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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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:
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Content distributed about the Market Authorization Holder's product must be on label.
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Content distributed about the competitor's products must not be disparaging (e.g. a selective/unfair attack).
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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.
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