Atlanta, July 24, 2023 – Arnall Golden Gregory (AGG) is pleased to announce that Robert “Bob” Durkin has been named co-chair of the firm’s Food & Drug practice group. Bob, who is based in the firm’s growing Washington, D.C. office, joined AGG in 2019 after more than 12 years with the U.S. Food & Drug Administration (FDA), most recently as Deputy Director of the Office of Dietary Supplement Programs (ODSP). In addition to leading the firm’s Food & Drug practice, he is co-chair of the Dietary Supplements industry team and a member of the Life Sciences industry team.
“Having served at FDA, specifically in the Center for Drug Evaluation and Research and the Center for Food Safety and Applied Nutrition, Bob draws from this incredible insight and brings a wealth of knowledge to clients. I am in the fortunate position of adding a co-chair with Bob’s caliber of experience and industry-renowned leadership,” said Alan G. Minsk, co-chair of AGG’s Food & Drug practice. “His background working for FDA provides him with the unique ability to effectively counsel clients who are subject to FDA oversight.”
At AGG, Bob helps clients understand the challenges presented by the regulations enforced by regulatory agencies, such as FDA, the Federal Trade Commission (FTC), and the United States Department of Agriculture (USDA). With his in-depth knowledge of the federal Food, Drug, and Cosmetic Act and real-world experience, Bob helps clients of all sizes navigate the countless regulatory issues that affect them and their products, through all stages of their lifecycle, to practical, business-minded solutions.
Bob also advises clients in connection with compliance and enforcement matters brought by the FDA and other federal state and regulatory bodies, with a focus on all aspects of the agency’s dietary supplement and food programs. He also provides counsel in response to actions taken by FDA, such as Warning Letters, seizures, consent decrees, injunctions, import detention/refusal, and more.
“I am grateful to lead AGG’s Food & Drug practice alongside my co-chair Alan Minsk,” said Bob. “I look forward to the opportunity to expand on my position to leverage my knowledge of FDA’s inner workings to help shape the practice’s goals, guide our talented attorneys, and continue achieving successful outcomes for our FDA-regulated clients.”
Bob’s legal counsel draws on his experience with the ODSP, where he was responsible for performing policy analysis and evaluations related to various dietary supplement programs. He was also 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. During this time, Bob also successfully led the Office through multiple Government Accountability Office (GAO) investigations.
Prior to joining ODSP, Bob was the acting director of FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Food Defense Staff. In this role, he led a dedicated group of professionals who determined the best regulatory strategies to help protect the U.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 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, he 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, unapproved new drugs, over-the-counter drugs, and pharmacy compounding.
Bob’s extensive educational background includes earning a law degree from the Widener University School of Law, a graduate certificate in the American Course on Drug Development and Regulatory Science from the University of California, a master’s degree from the University of Hawaii at Manoa, and an undergraduate degree from the Philadelphia College of Pharmacy and Science. He also completed a nuclear pharmacy practice residency with Walter Reed Army Medical Center
ABOUT ARNALL GOLDEN GREGORY LLP
Arnall Golden Gregory (AGG) is an Am Law 200 law firm with offices in Atlanta and Washington, D.C. Our client-service model is rooted in taking a “business sensibility” approach to fully understand how our clients’ specific legal matters fit into their overall business objectives. Our transactional, litigation, and regulatory counselors serve clients in healthcare, real estate, litigation and other dispute resolution, business transactions, fintech, life sciences, technology, intellectual property, global commerce, economic development, public finance, and government investigations. With our rich experience and know-how, we don’t ask “if,” we figure out “how.” Visit us at www.agg.com.