Recognizing the need for better information about the safety of consumer products, Congress directed the Food and Drug Administration (FDA) to establish an active surveillance system for monitoring post-market drugs and medical products. In May 2008, FDA unveiled the Sentinel Initiative – a national electronic data system designed to track drug and medical product performance and ultimately to improve public health.
On January 11, the Engelberg Center convened the 2nd Annual Sentinel Initiative Public Workshop, bringing together key stakeholders to explore a range of issues, including recently completed FDA contracts committed to the development of the Sentinel System and ongoing pilot projects tracking medical product safety. Broader discussion topics focused on maintaining patient privacy while conducting medical product safety surveillance; developing the Sentinel System as a national resource for medical product safety surveillance that would allow access to others beyond FDA, and developing a multi-purpose distributed system to conduct not only safety surveillance work but also for comparative effectiveness research, product quality assessment, and other types of health questions.
Margaret A. Hamburg MD; U.S. Food and Drug Administration; Silver Spring, MD
Kristen B Rosati JD, Coppersmith Schermer & Brockelman PLC, Phoenix, AZ; Jeffrey S. Brown, PhD, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA;
Jennifer Nelson PhD, Group Health Research Institute, Seattle, WA;
Janet Woodcock MD, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD;
Patrick Ryan PhD, Janssen Research and Development, Raritan, NJ;
Richard Platt MD, MSc, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA