238 - Hi PAAB: Educational material on disease state is being put together in an APS for doctors to distribute to appropriate patients, after the doctor has educated the patient on the disease state. The doctor will provide the handouts to the patients at his/her discretion. Is inclusion of a branded section on how to use the product allowable for this APS?

  • If the intent is for product branded content to be distributed with the disease state piece, then the PAAB should be asked to review the disease state piece in a product branded context. The answer is yes only when this is done. The principle outlined in Q&A 232 applies to patient information as well.