Douglas Stearn, J.D., Principal Deputy Associate Commissioner for Inspections and Investigations (PDACII)
Douglas Stearn is the Principal Deputy Associate Commissioner for Inspections and Investigations (PDACII) in the FDA Office of Inspections and Investigations (OII). He leads OII functions, projects, and engagements on behalf of the Associate Commissioner and directly oversees cross-cutting functions that include information technology, education and training, emergency operations, operational policy, and recalls. He served as the Deputy Associate Commissioner in the Office of Regulatory Affairs (ORA) for nearly one year before the FDA reorganization in October 2024.
Between 2018 and 2023, Mr. Stearn was deputy director for regulatory affairs in the FDA Center for Food Safety and Applied Nutrition. In this role, he oversaw regulatory programs related to the food supply under FDA jurisdiction and managed a team of senior executives responsible for compliance functions and regulatory programs involving food safety, outbreak response, and dietary supplements. Previous roles include director of the FDA’s Office of Enforcement and Import Operations, assistant director and then deputy director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER), and director of the ORA Division of Compliance Policy.
Before joining the FDA, Mr. Stearn served as a trial attorney in the U.S. Department of Justice’s Office of Consumer Litigation for more than fifteen years. In this role, he litigated numerous civil and criminal cases referred by the FDA and other consumer protection agencies. He was also the law clerk for U.S. District Judge James Latchum in Wilmington, Delaware. He received his law degree from Cornell University and his undergraduate degree from Brown University.
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