Bob is a partner in the Food & Drug and Healthcare practices and a member of the Dietary Supplements and Life Sciences industry teams. 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.
- University of California, Graduate Certificate: American Course on Drug Development and Regulatory Science
- Widener University School of Law, Juris Doctor,cum laude
- University of Hawaii at Manoa, Master of Science
- Walter Reed Army Medical Center, Nuclear Pharmacy Practice Residency
- Philadelphia College of Pharmacy and Science, Bachelor of Science
- State of Pennsylvania
- *Not admitted in the District of Columbia. Supervised by a member of the District of Columbia Bar.
News & Insights
- PublicationsI Wish I Knew What I Know Now: Conversations With AGG on FDA Issues2023 | Podcasts | Arnall Golden Gregory LLP
- EventsBob Durkin Moderating Panel During USP Virtual Dietary Supplements & Herbal Medicines Stakeholder ForumFebruary 16, 2023 | Speaking Engagements
- EventsYou’re Not Paranoid If Indeed the Government Is Out to Get You: A Review of (Some) 2022 Enforcement Actions by the DOJ and FDA Against Life Sciences CompaniesFebruary 2, 2023 | AGG Seminars & Webinars
- Legal Update on the Coronavirus and Dietary Supplement Industry
- With One Warning Letter, FDA Demonstrates Many of the Ways It Can Establish the Intended Use of a Product Labeled as a Dietary Supplement
- FDA Decision to Suspend On-Site Inspections Shifts Safety Guarantees to Manufacturers
- Bob Durkin to Present “COVID-19 and Beyond: Crisis Preparation, Management, and Recovery in the Food and Dietary Supplement Industries”
- LIVE Discussion Tonight: COVID-19 Conference Call on Food Stakeholder Guidance, Pending Legislation, Supply Chain and More