news July 8, 2024

Renowned FDA Attorney Robert Durkin Joins Amin Wasserman Gurnani

Amin Wasserman Gurnani Welcomes Former Acting Director for FDA’s Office of Dietary Supplement Programs as Co-Chair of the Firm’s Regulatory Group.

Robert “Bob” Durkin to co-lead regulatory practice with partner Rend Al-Mondhiry.

Washington, DC, July 8, 2024–Amin Wasserman Gurnani (AWG) is pleased to announce that Robert Durkin has joined the firm as a partner and co-chair of its Regulatory Group in Washington, DC.

Durkin will lead AWG’s Regulatory practice alongside firm partner and longstanding Regulatory Group team member Rend Al-Mondhiry.

A renowned advisor on complex compliance and enforcement matters for companies of all sizes, Durkin honed his approach through his 12-year career at FDA, including serving as 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). His role involved policy analysis and evaluations across all aspects of the agency’s dietary supplement programs and spearheading innovative programs on compliance and enforcement issues, such as Warning Letters, seizures, injunctions, and import detention/refusal. He participated in various 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. Durkin also successfully guided the ODSP through multiple GAO investigations. As the Acting Director of CFSAN’s Food Defense Staff, Durkin steered the team responsible for determining the best regulatory strategies to protect our nation’s food supply from intentional contamination.

“Attracting nationally recognized leaders like Bob is a testament not only to our work on the most sophisticated matters before the Food & Drug Administration, Federal Trade Commission, National Advertising Division, and in the courts, but also to our culture,” said Managing Partner Ivan Wasserman. “Like Rend, Bob‘s longstanding dedication to the industries we serve and his ‘team first’ approach make him an ideal fit for our firm,” he said. “Bob further enhances our ability to partner with clients to unravel the complexities of FDA compliance while mitigating the risks associated with the design, labeling, and promotion of their products in the hyper-competitive health and wellness markets,” stated Wasserman.

“We are thrilled to have Bob join us,” said Rend Al-Mondhiry, newly appointed co-chair of AWG’s Regulatory Group. “With his knowledge of FDA’s inner workings, clients will benefit from his insights and ability to ‘see around corners’ for them while navigating the intricacies of an ever-changing FDA landscape,” stated Al-Mondhiry.

“AWG has a standout practice representing clients subject to FDA oversight, said Durkin. “I look forward to strengthening the group’s powerhouse status alongside Rend. She builds and expands longstanding client relationships, and her entrepreneurial drive is second to none,” he stated. “I was also attracted to the firm’s reputation for excellence and its supportive and collaborative culture and couldn’t be more excited to join this dynamic team,” said Durkin.