Profile

Gary focuses his practice on issues involving the U.S. Food and Drug Administration (FDA), with a particular interest in clinical research, contract research organization, and sponsor matters. He has also represented clients in matters involving the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), the U.S. Environmental Protection Agency (EPA), the U.S. Consumer Product Safety Commission (CPSC), the Federal Trade Commission (FTC), and various states. He has represented numerous clients in cases involving labeling, importation, regulatory marketing strategy, recalls, seizures, and criminal matters. Gary is a frequent speaker on FDA regulatory issues and received the FDA’s Award of Merit in 1974 for legal review of the organization’s over-the-counter review process. He also served as president of the Food and Drug Law Institute, receiving the FDLI Distinguished Service and Leadership Award in 1988.

Experience

Representative Matters

  • Advises individuals, partnerships, and corporations in matters involving new drug applications, food ingredient marketing, importation, regulatory marketing strategy, recalls, seizures, and criminal matters.
  • Counsels clients in the drug industry in matters ranging from ingredient safety questions and preparation of Investigational New Drug (IND) applications to the preparation of New Drug Applications (NDA) and GRAS Notifications.
  • Advises clients in the food industry on ingredient safety questions and product labeling.

Professional Experience

  • University of Florida, Instructor (2006-2019)
  • Private Law Practice (1986-2019)
  • President, The Food and Drug Law Institute (FDLI) (1976-1985)
  • Office of the General Counsel, U.S. Food and Drug Administration (FDA) (1969-1976)
  • Legal Coordinator, Centers for Disease Control and Prevention (1968-1969)

Affiliations

  • Chairman, UNC Eshelman School of Pharmacy (2010, 2012)
  • Member of Foundation Board, UNC Eshelman School of Pharmacy

Recognitions

  • Recognized by Chambers USA in 2017 as an experienced practitioner in Healthcare
  • Recognized by UNC Pharmacy Alumni Association in 2012 with the “Distinguished Service Award”
  • Recognized by the FDA with the “FDA Award of Merit” in 1974 for his work on the OTC review

Credentials

Education

J.D., Emory University School of Law

M.S., Purdue University

B.S., University of North Carolina

Bar and Court Memberships

  • District of Columbia
  • U.S. Supreme Court
  • U.S. District Court for the District of Columbia

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