Robert Durkin

Of Counsel

Fax: 202.677.4905
Washington
1775 Pennsylvania Avenue NW
Suite 1000
Washington, District of Columbia 20006

Biography

Bob joins AGG as of counsel in the firm’s FDA and Healthcare practices, and is a member of the Dietary Supplements 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: Agency-wide Marijuana Working Group, 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, 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 over-all 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.

Credentials

  • 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.