Labeling: BIO Comments on FDA Draft Guidance on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

Re: Docket No. FDA–2013-D-0401: Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” 

BIO represents more than 1,100 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 the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. 

BIO supports FDA’s efforts to help prescription drug and biologic product manufacturers minimize medication errors associated with their products.  We recognize the importance of minimizing the risks of medication errors associated with the design of a drug products labeling and packaging.  In 2007, BIO endorsed the Prescription Drug User Fee Act IV reauthorization and expansion that was signed into law as part of the Food and Drug Administration Amendments Acts of 2007 (FDAAA) (Public Law 110-85), which committed FDA to certain performance goals, including measures to reduce medication errors related to trade names, labeling, and packaging design.

BIO agrees that product container labels and carton labeling should clearly and accurately communicate information that is critical to the safe use of a medication.  Safe use includes the ability to accurately and completely identify the specific product received by a patient, as incorrect attribution of adverse events to a particular product in safety reporting is itself a critical medication error.  BIO offers specific, detailed comments to the Guidance seeking clarification and better understanding of the recommendations in the spirit of promoting patient well-being and safety, ensuring the utility and integrity of pharmacovigilance practices, and efficient and effective implementation.

BIO appreciates this opportunity to comment on the “Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.”  We would be pleased to provide further input or clarification of our comments, as needed.