Jason Sapsin is a member of Polsinelli Shughart's Life Sciences group, leading its FDA practice based in Denver, Colorado and is an instructor in regulatory affairs at Colorado State University's School of Biomedical Engineering. His clients include international food and medical device companies; clinical laboratories; pharmaceutical companies; biologics companies; dietary supplement companies; national health systems and clinical researchers. Mr. Sapsin assists companies and institutions bringing new medical products to market, including providing advice on the monitoring and regulation of sponsored clinical investigations and the duties of clinical investigators. Formerly Associate Chief Counsel in the Food and Drug Administration's Office of Chief Counsel, Washington, D.C., Mr. Sapsin advised FDA in investigations and in pursuing seizures, injunctions, product recalls and other enforcement action against drugs, dietary supplements and adulterated foods, negotiated with affected industry, provided technical assistance on pending legislation, assisted the agency in responding to civil litigation and GAO audits of FDA's domestic and international programs, and served as counsel to the Deputy Associate Commissioner for Regulatory Affairs in the Office of Regulatory Affairs (the enforcement arm of FDA). Mr. Sapsin has participated in several significant regulatory actions including the agency's promulgation of rules and guidance regarding fresh produce and nutritional labeling and FDA's expansion of cooperation between federal and state regulatory authorities in enforcement and regulatory actions. He has also advised FDA regarding the federal grants process.
Before joining FDA Mr. Sapsin served as a Maryland Assistant Attorney General, representing and advising the Maryland Department of Health and Mental Hygiene, the Maryland Health Care Commission and the Maryland Community Health Resources Commission. In that capacity, he represented the State of Maryland in contested Certificate of Need determinations, reviewing clinical research programs, appellate proceedings in state courts and the United States Court of Appeals for the Fourth Circuit, grants and acquisitions, and the development and modification of insurance and public health regulatory programs.
Mr. Sapsin is a co-author of the Model State Emergency Health Powers Act and author of publications on public health law and preparedness, international trade and health, litigation and public health, vaccine policy, and SARS. A former Assistant Scientist in the Johns Hopkins Bloomberg School of Public Health, he served as faculty in Johns Hopkins' Center for Public Health Preparedness and Centers for Environmental Health Tracking and Practice and in the Georgetown and Johns Hopkins Universities' Center for Law and the Public’s Health. Mr. Sapsin has presented and developed training materials for the Centers for Disease Control and Prevention (CDC), the American Public Health Association, the Center for Strategic and International Studies, the American Bar Association, Health Canada, regional Public Health Leadership Institutes and state health departments. He has been a consultant to the Association of State and Territorial Health Officials and the Baltimore City and Washington, D.C. health departments.
Mr. Sapsin is a graduate of Williams College, the University of Michigan Law School and Johns Hopkins University. Prior to focusing on life sciences, health and FDA regulatory law he practiced international litigation and domestic civil litigation, advised on health legislative policy and served as a corporate vice president and general counsel. Mr. Sapsin's community activities have focused primarily on child education and welfare.