Companies put great effort into making sure the front of the ad catches the consumer's attention.
The Patient Package Insert influences the impact of both the DTC advertising and the entire patient compliance program. It should function as the foundation of the consumer information and compliance programs. The Patient Package Insert should be so solid clinically that its content provides a good roadmap for handling FDA regulatory issues or concerns later. Achieving that level of accuracy requires the ability to review Professional Labeling with an eye to both what is important for the consumer to know and what FDA will demand to see. That's a fine line.