On December 8 and 9, 2014, the Food and Drug Law Institute (FDLI) held its annual Enforcement, Litigation & Compliance Conference in Washington, D.C. Speakers from the U.S. Food and Drug Administration (FDA), Department of Justice (DOJ), and other federal agencies, as well as representatives from industry and the private bar, discussed recent activity and predictions for federal regulation of food, drugs, medical devices, cosmetics, dietary supplements, and tobacco in 2015.
- Several speakers talked about FDA’s restructuring efforts and how that will change the way the agency functions.
- Several FDA representatives explained that this is being driven in part to maximize resources and to re-align the various Centers with the Office of Regulatory Affairs (ORA), to build expertise, create sector-specific groups, and better coordinate inspection and enforcement efforts. It was predicted that generalist FDA inspectors will be a thing of the past and that there will be commodity-specific inspectors who have real time access to scientists during inspections. It was noted that this new approach may pose some challenges for FDA, which has traditionally functioned in silos.
- Panelists expressed hope that the changes will lead to more uniformity in FDA’s inspections and enforcement and will, for example, result in less strategic port-shopping by importers.