Clients turn to Marci Norton to navigate the complex statutes and regulations administered by the U.S. Food and Drug Administration. She provides federal regulatory and compliance advice to a range of companies across the health care, life sciences, and food and beverage industries, bringing a unique perspective after nearly 30 years in the FDA’s Office of the Chief Counsel (OCC). In that role, she interpreted and applied the agency's laws, including the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations, and the Public Health Service Act’s (PHSA) provisions governing biological products, mammography quality standards, communicable disease control, and the ClinicalTrials.gov database requirements.
Throughout her career in FDA’s OCC, where she served in a senior counsel role for nearly 23 years, Marci worked with the Department of Justice (DOJ), representing the FDA in judicial enforcement actions in fast-changing areas of the law relating to food (including dietary supplements and infant formula), drugs, medical devices, biological products, tobacco products, and cosmetics. She also drafted and negotiated consent decrees resolving complex cases, which involved violations of the drug and dietary supplement current good manufacturing practice (CGMP) requirements and the device quality system (QS) requirements, and she monitored and ensured continuing compliance with those decrees.
Marci was the sole litigator advising the FDA's medical product centers on the ClinicalTrials.gov requirements and took a lead role in developing the agency’s compliance and enforcement program relating to those requirements. She spent nearly a year serving as the agency's acting associate deputy chief counsel for litigation, managing and leading a team of more than 30 attorneys in implementing priorities and reviewing requests to initiate enforcement action, among other responsibilities.
Marci earned her law degree from the University of Virginia and went on to clerk for the Maryland Court of Special Appeals (now known as the Appellate Court of Maryland). She began her career as a computer engineer with NASA after earning a bachelor's degree in computer science from the University of Maryland Baltimore County.