FDA Regulatory Affairs Expert Witness

Expert Qualifications

A 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal Investigations (OCI) and as an analytical regulatory microbiologist. During his last three years at FDA he spearheaded the agency's integration efforts with Customs and USDA on crosscutting interagency enforcement and operational issues; served as the FDA's point-person in managing the intersection of imports and FDA's new bioterrorism regulations; established joint agency and industry working groups to evaluate counterfeiting and tampering risks to food and drug distribution supply chains; was the agency lead in its strategic planning efforts to reinvent the FDA's import programs; wrote the initial statement of work and acted as program manager over the FDA's new PREDICT, risk-based electronic entry screening system; and directed the development of the FDA's agency-wide Risk-based Import Strategic Plan designed to improve compliance of foods, dietary supplements, drugs, medical devices, cosmetics, and biological products imported into the U.S. As CEO of a FDA consulting firm and Founder of an affiliated law firm, he currently represents domestic and foreign companies of all sizes, assisting them in identifying USDA, FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and state requirements. He focuses his practice on FDA matters, including but not limited to: matters relating to FDA inspections, FDA criminal, regulatory and administrative enforcement actions for medical devices, drugs, cosmetics, alcohol, tobacco, dietary supplements, and foods.