Attachment of clinical reprints in an RTE
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Re: Rep triggered e-mails
As a follow on question, in the the same context as described previously (no branding or drug mention in the e-mail itself, what would be the naming convention for clinical reprints attached to an RTE? For clinical reprints for which we have already obtained PAAB approval to distribute for a brand, would it suffice to have the author name, journal and year e.g., "Smith, NEJM 2015" with no fair balance needed? Could the acronym of the study name be included e.g., "Smith, NEJM 2015 PRTII study", and still require no fair balance?
Thanks again -
Good question. In the same context as described in your previous question Rep triggered e-mails | Forum, a similar principle would apply to the naming conventions for clinical reprints attached to an RTE. Assuming the naming convention is claim-neutral (e.g. Smith, NEJM 2015) as per your example, fair balance would not be required. However, study acronyms are considered different. We review naming conventions in a similar way to subject lines or small space ads, so the RTE would require the appropriate fair balance (level of balance TBD depending on the specific language used in the naming convention) if they contain more than one of the following elements: product name, study endpoint or study name (i.e. study acronym). A combination of more than one of these elements has the potential to allude to a message/claim that requires fair balance.
