Douglas Stearn FDA

Douglas Stearn is currently the director of the Office of Enforcement and Import Operations. The office is comprised of the Division of Import Operations, the Division of Enforcement, and the Division of Compliance Systems, which are the ORA headquarters units responsible for coordinating activities related to imports, compliance, recalls, and data systems. Mr. Stearn began this position in December 2013 after spending almost four years as the assistant director and then the deputy director of the Office of Compliance within FDA’s Center for Drug Evaluation and Research. Prior to joining CDER, Mr. Stearn was the director of the Division of Compliance Policy in the Office of Enforcement for almost two years. Mr. Stearn received his undergraduate degree from Brown University in 1987. He received his law degree in 1991 from Cornell Law School. Immediately before joining FDA, Mr. Stearn worked as a trial attorney in the U.S. Department of Justice’s Office of Consumer Litigation for over fifteen years. In the course of his work at the Department of Justice, Mr. Stearn litigated numerous civil and criminal cases referred by FDA and other consumer protection agencies.