Re: Docket No. FDA-2008-N-0038
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration
(FDA) for the opportunity to submit comments on the FDA’s Consumer Medication Information (CMI) Initiative. 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 nonstandardized and duplicative. BIO encourages FDA to collaborate with stakeholders to develop a single patient-oriented medication document with standardized format and content informed by social science and behavioral research to be used to communicate product information to patients.
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 the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
BIO’s healthcare members understand the need for patients and physicians to have up-to-date, relevant, and accurate information about the benefits and risks of a drug or biologic so they can make well-informed choices about therapy. The professional physician label is the cornerstone of every prescribing decision and includes important benefit/risk information to guide medical decision-making. However, the professional label is written in a manner intended for physicians and other medical professionals. Additional consumer-friendly written materials can be useful to help patients understand the benefits and risks of a product, to increase patient compliance, and to help inform patients when a follow-up with their physician may be warranted.
Under current practice, a patient being dispensed a medication at a pharmacy or other healthcare setting may receive a combination of several separate documents including a CMI prepared by a third-party vendor, and/or a FDA-approved MedGuide, or a PPI. Patients may also receive product information from the brief summary section of direct-to-consumer advertising. These different types of written patient-oriented communications are the result of a series of laws, regulations, and guidance documents spanning several decades. The most notable of these is a 1996 law (P.L. 104-180) which established a voluntary private-sector initiative to provide useful written information for patients of new prescriptions 95% of the time by 2006. As demonstrated by a 2008 evaluation of CMI, the initiative has struggled to meet that goal.1 The evaluation found that the quality and comprehensibility of CMIs can be variable; the format and content can be difficult for patients to read; and the information provided may be duplicative of other formats. This can contribute to suboptimal comprehension of important prescribing information. BIO is encouraged by FDA’s ongoing evaluation of new initiatives to provide patients with the tools they need to understand and manage their medications to achieve optimal compliance and health outcomes.
I. A SINGLE PATIENT-ORIENTED WRITTEN COMMUNICATION:
BIO supports efforts to streamline this process to ensure that patients receive high quality and easily understandable medication information, and is pleased to offer the following recommendations.