Seth Ray focuses his practice on FDA regulatory issues that arise in product liability litigation and investigations, and provides regulatory counseling to the firm's pharmaceutical clients.
Prior to joining O’Melveny, Seth served as Senior Advisor and Regulatory Counsel for the FDA’s Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising, and Communications (DDMAC). He provided expert legal and policy advice to senior managers on all significant guidance documents, enforcement actions, legislative proposals, and other complex, sensitive matters. In addition, Seth devoted time to mentoring younger attorneys. Seth also provided input on enhancing interactions with the FDA’s Office of Chief Counsel, in which he worked as an attorney for more than two decades.
Seth fulfilled three different roles throughout his involvement in the Office of Chief Counsel. As Associate Deputy Chief Counsel for Drugs and Biologics, Seth supervised the drugs and biologics counseling teams, approximately 25 attorneys total; served as the Senior Legal Counsel on all prescription drug advertising and promotion matters; and managed the Office’s attorney recruitment. As Associate Chief Counsel for Drugs, Seth provided legal counsel to the Center for Drug Evaluation and Research (CDER) and other FDA components on a variety of drug-related matters – including prescription drug approvals, labeling, safety, advertising and associated compliance issues. Lastly, as Associate Chief Counsel for Enforcement, Seth assumed responsibility for all phases of civil and criminal litigation in several product areas.
Seth previously served as an Assistant State Attorney for Broward County, Florida (in the Felony Trial Division and the Juvenile Division); an FBI Special Agent in Florida and Tennessee; and a Trial Attorney within the Tax Division of the United States Department of Justice. He earned his J.D. from Emory University School of Law and his B.A. from Dickinson College.
