54 - Can we create a program that is directed towards patients as the recipients? Is this considered advertising (direct-to-consumer)? Would it require PAAB review? The content within the program would be on-label.
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Patient support programs are widely used in the market place. They are directed to patients only and are not suitable for "direct-to-consumer" audience. Patient support programs are intended to help patients gain a better understanding of the drug therapy that they are being prescribed. The information should be consistent with the patient information section of the product monograph (Section III of the monograph) and presented in a non-promotional manner. Patient directed materials are subject to the PAAB review as per PAAB Code section 6.
