503 - We were granted a new indication based on a pivotal study. However, some datapoints in the published study, in a peer-review journal, are not found in the TMA. We would like to know if it is "off label" for our reps to speak to those data points since it is extra data points in our studied population for which we have an indication? Can they use the reprint and speak to those results?

  • Drug rep activities do not fall under the scope of the PAAB. Whether the content can appear within advertising materials is a matter that falls under the scope of the PAAB code. We can assess whether the specific content from this study would be acceptable in advertising in the context of a formal PAAB opinion submission (see our fee schedule). The number of variables that require consideration causes this question not to be amenable to a general answer.