Question: It is our understanding that an APS that only contains dosing information (i.e., a standard dose card with no messages of efficacy or safety) would typically require low level fair balance (as per the Guidance on Base Fair Balance Level Selection and Placement in HCP advertising). However, if an APS contains information relating to dose modifications due to safety concerns, would that change the fair balance requirement from low to middle? (even though the dose modifications section is within the DOSAGE AND ADMISTRATION section of the PM). Dosage modifications seems to be inherently a ‘safety’ concern – and we question whether this would prompt a higher level of fair balance.
Jennifer Carroll last edited by
The nature of the dosing modifications and the manner in which they are presented, will impact the level of fair balance. A dosing tool with cautionary dosing modifications may be subject to the lowest level fair balance. If the modifications are positioned as a product benefit it will likely require highest level fair balance.