Patient Therapy: Patient Medication Information

BIO submitted comments on FDA’s "Development and Distribution of Patient Medication Information for Prescription Drugs." The comments elaborate on previous comments and further address the questions raised at the September 27-28 public hearing. The comments support the development of effective Patient Medication Information (PMI) that reinforces communication between the patient and healthcare professionals, enables understanding of benefits and risks of a product, and promotes safe and effective use of medication. The comments endorse a single patient-oriented document written by the Sponsor, reviewed and approved by FDA, and based on a template that has been validated through social-science research of patient comprehension. The comments also state that technology should be leveraged to enhance electronic dissemination and distribution of PMI.