E-Labeling: BIO Letter on FDA Rulemaking on Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products

 Dear Commissioner Hamburg and Director Burwell:

On behalf of the member companies of Biotechnology Industry Organization (BIO), we respectfully request that the Office of Management and Budget (OMB) issue the proposed Food and Drug Administration (FDA) regulation on the electronic distribution of prescribing information for human drugs and biologics. Once implemented, the rule will provide patients, providers, and caregivers with timely access to the most up-to-date prescribing information to inform the safe use of FDA-approved therapies.
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.
We note that the current regulatory agenda lists a goal of issuing FDA’s proposed rule on Electronic Distribution of Content of Labeling for Human Prescription Drug and Biological Products in January 2014. We understand that the rule was previously submitted to OMB for review, and we encourage OMB to help FDA meet that goal. BIO believes FDA has ample authority to enact paperless labeling, as Congress has not prescribed a specific mechanism of dissemination in the statute.
As a preliminary matter, it is also important to clarify the types of labeling printed for prescription drug products. The FDA-approved prescription drug product labeling, or the US Prescribing Information (USPI), is intended for Health Care Providers (HCPs) and prescribers, and contains a summary of FDA-approved scientific information to safely and effectively use or prescribe the prescription drug product according to its FDA-approved indications. The USPI’s unfolded size often rivals that of a city roadmap, even being printed in 6 point font, on both sides. At least one copy of the USPI is required to accompany every container of drug product dispatched by a manufacturer into interstate commerce. While sometimes multiple prescriptions can be filled from a single container dispatched from the manufacturer, to understand the volume of road-map sized USPI’s printed annually, there were approximately 4 billion prescriptions written each year, from 2010 to 2012. In this modern era of ubiquitous information technology and real-time communication, this paper-based approach to the dissemination of important new medical information is wasteful, uneconomical, and inefficient. As such, BIO fully supports replacing the paper USPI with electronic distribution, with paper copies available upon request.
The FDA’s proposed rule concerns only the dissemination of the USPI to healthcare professionals, and this is the subject of our letter. Other patient-oriented documents intended to help individual consumers understand a drug or biologic’s benefits and risks, but that are not within the scope of the proposed rule, may include a Medication Guide (MedGuide), Patient Package Insert (PPI), Consumer Medication Information (CMI), FDA’s new Patient Medication Information (PMI) Initiative, and any other documents or instructions created by the dispenser (e.g. the prescriber or pharmacy). In addition to electronic dissemination of the USPI, BIO also supports digital distribution and posting of the PMI in a centralized online repository so that patients and providers can access both professional and patient-oriented labeling in a more efficient manner.
In light of the evolution on information technology over the last thirty years, 21st century health care professionals have a growing expectation to access digital healthcare information. E-labeling is a proven solution that will have meaningful advantages for the public health and will reduce waste to benefit the environment.