Robert Durkin

Bob is a partner and co-chair of the Food & Drug practice and Dietary Supplements industry team. He also serves as a member of the Healthcare practice and Life Sciences industry team. As a former acting Director and Deputy Director of the Office of Dietary Supplement Programs (ODSP) in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), he brings a wealth of knowledge and insight to his legal practice. In working with AGG clients, Bob will draw from the extensive experience he gained at the FDA where he was responsible for performing policy analysis and evaluations related to all aspects of the agency’s dietary supplement programs while also providing skillful advice on compliance and enforcement issues (such as Warning Letters, seizures, injunctions, import detention/refusal, etc.). During this time, he was active in a variety of agency working groups, including the Agency-wide Marijuana Working Group, the Agency-wide CBD Policy Working Group, and the Agency-wide Investigational New Drug (IND) Policy Working Group. While helping to lead ODSP, Bob also successfully led the Office through multiple GAO investigations.

Just prior to joining ODSP, Bob was the acting Director of CFSAN’s Food Defense Staff. In this role, Bob led a dedicated group of professionals whose duty it was to determine the best regulatory strategies to help protect our nation’s food supply from intentional contamination. The Food Defense staff’s work includes the implantation of the Food Safety and Modernization Act’s Rule for Mitigation Strategies to Protect Food against Intentional Adulteration and determining the best ways to educate, and then regulate, the industry relative to the Rule.

Bob has also served in both the Commissioner’s office and the Center for Drug Evaluation and Research (CDER). While in the Commissioner’s Office, Bob managed a staff of Emergency Response Coordinators whose focus was on coordinating an overall Agency approach to mitigate and respond to urgent health concerns related to FDA-regulated commodities. While at CDER, Bob worked in the areas of health fraud, over-the-counter drugs, and pharmacy compounding.