By: Richard M. Klein
FDA has a long history of working with patients and patient advocates, beginning with the AIDS crisis of the 1980s. Our interactions with patient groups have evolved since then, and the agency now works with patients representing a broad spectrum of diseases and conditions.
FDA’s Office of Special Health Issues (OSHI) is the agency’s primary interface with patients and the patient advocacy community. OSHI educates patient advocates about medical product regulations and looks at ways to more effectively involve patients in regulatory decisions that affect them. We also assist patients with a broad range of patient issues related to approved and investigational medical products, including information about clinical trials and where to find studies, and about when access to investigational products outside of trials might be appropriate. Our office is expanding its efforts to communicate with patients by creating The Patient Network, a comprehensive new program designed to maximize our ability to outreach to patient groups.
The first component of the network is the twice monthly newsletter, Patient Network News launched in 2011. It provides FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.
Secondly, additional information will be available at a mouseclick when FDA unveils a new patient-centered web site later this year.
And a few weeks ago we inaugurated a third component of our new patient programming, an annual Patient Network Meeting. Held on May, 18, 2012, the first meeting focused on discussions of benefit-risk decision-making. FDA Working with Patients to Explore Benefit/Risk: Opportunities and Challenges, included an overview of the regulatory process for developing and bringing medical products to market and other aspects of FDA regulation and included ample time for audience participation and interaction during the day.
We believe it’s critical that we bring patients into the process of determining the best way to incorporate their level of risk tolerance when considering the potential benefits of medical products. It is also important to find ways to better characterize and communicate potential risks associated with particular medical products so that patients can better assess the balance against their medical needs, and make more informed decisions about their medical options.
Our inaugural Patient Network Meeting is the beginning of a new, fruitful dialog with patient communities, collecting valuable thoughts and suggestions. When patients can work together with us addressing the wide range of conditions and diseases they deal with on a daily basis, everyone benefits.
Richard M. Klein, is Director of the Patient Liaison Program in FDA’s Office of Special Health Issues.