Obesity Devices And The FDA Review Process: An Interview With Lee Kaplan, MD

Medtech Insight interviewes Lee Kaplan, MD, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital and co-director of an upcoming meeting delineating best practices for clinical trials in the field of bariatrics.

Obesity Devices And The FDA Review Process: An Interview With Lee Kaplan, MD

With increasing concerns about the US Food & Drug Administration (FDA) review process and its impact on innovation in the obesity arena, members of academia and industry are working with the FDA to identify best practices for clinical trials and help standardize the clinical investigation and review process. As part of this initiative, the FDA, Massachusetts General Hospital (MGH), and Dartmouth College are sponsoring a much anticipated public meeting and workshop in October 2011 that will focus on delineating best practices for clinical trials in the field of bariatrics. To find out more, Medtech Insight interviewed one of the meeting co-directors, Lee Kaplan, MD, director of the Obesity, Metabolism and Nutrition Institute at MGH, in Boston. According to Kaplan, patient need in the obesity field is "enormous and generally unmet," so it is important for the field to "adopt strategies that will facilitate bringing new, effective therapies to market."

Q: Medtech Insight: How has academia been working with the FDA in terms of improving the FDA review process for weight loss devices?

Lee Kaplan: We've been working with the FDA to help identify best practices for clinical trials of devices for obesity and metabolic disorders and how to assess the effectiveness of medical devices in this area in a more standardized and predictable way. It has been a stepwise process. Because of the importance of this effort, representatives of the American Society for Metabolic and Bariatric Surgery (ASMBS) and the American Society for Gastrointestinal Endoscopy (ASGE) met with the FDA in the summer of 2010 and recently presented a white paper outlining the perspective of these two societies regarding what should be done in this area. In follow-up to that, we are putting together a public meeting in October 2011, sponsored by the FDA, MGH, and Dartmouth, to take it to the next level. The meeting will be a workshop on clinical trials and GI devices for the treatment of obesity and related metabolic disorders. The conference is being formulated right now, and over the next couple of weeks we will distribute the details.