Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration
(FDA) for the opportunity to submit comments on “Providing Effective Information to
Consumers about Prescription Drug Risks and Benefits.” BIO believes that patients and
healthcare professionals should have access to up-to-date, relevant, and accurate product
information available in an easily accessible form in order to inform individual medical decisions and ensure the safe utilization of medications. Under current practice, patients may receive several different types of patient-oriented written communication at the time of dispensing – such as Consumer Medication Information (CMI), Medication Guides (MedGuide), and Patient Package Inserts (PPI) – that may be non-standardized and duplicative.
In previous comments (Appendix B), BIO endorsed the development of a single written patient-oriented document to be used to communicate product benefit and risk information to patients. BIO believes this patient document should be drafted by the sponsor, reviewed and approved by FDA, and based on a template that has been validated through social-science research of patient comprehension.
BIO also believes that technology should be leveraged to enhance dissemination and distribution of the most up-to-date patient labeling. We applaud the FDA for convening the September 24th-25th public workshop to identify the ideal attributes of the document and how it can be best distributed to patients. BIO is pleased to offer the following considerations to elaborate on our previous comments and workshop testimony.
BIO represents more than 1,200 biotechnology companies, academic institutions, state
biotechnology centers and related organizations across the United States and in more than 30
other nations. BIO members are involved in the research and development of innovative
healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding BIO Comments on Providing Effective Information to Consumers about Prescription Drug Risks and Benefits the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.