Seth is of counsel in the Food & Drug and Healthcare practices. FDA regulatory issues are the core of Seth’s practice. Over the course of his career, Seth has honed his expertise in this highly specialized area and as a result, clients seek his advice for drug approval issues, prescription drug labeling, prescription drug advertising/promotion, drug safety, the regulation of clinical trials, a range of compliance issues, and biologics regulation and issues.
Prior to joining the firm, Seth served as an attorney and manager in the Office of Chief Counsel at FDA (OCC) for 24 years. First, as an Associate Chief Counsel for Enforcement, and then as Associate Chief Counsel for Drugs, providing advice to the Center for Drugs (CDER) and other parts of FDA on a variety of drug matters. Seth also served as Associate Deputy Chief Counsel for Drugs and Biologics, managing the drugs and biologics attorney counseling teams and serving as senior counsel on all prescription drug advertising/promotion matters. He also spent 2 years in FDA’s Office of Prescription Drug Promotion (OPDP), serving as Senior Advisor and Regulatory Counsel, providing OPDP with expert legal and policy advice on significant guidance documents, enforcement actions, and other complex matters. Seth was also an FBI Special Agent in Florida and Tennessee, a Trial Attorney in the Tax Division of the United States Department of Justice and an Assistant State Attorney in Florida.