James Fraser is a former Associate Chief Counsel at the U.S. Food & Drug Administration. He represents and advises pharmaceutical companies, medical device companies, and other industry clients in FDA-related regulatory, compliance, and enforcement matters. He also represents pharmaceutical and medical device companies in mass tort and other product liability litigation.
In his five years at FDA (August 2016 – August 2021), James represented the agency in civil litigation and potential civil litigation throughout the United States. In so doing, he worked closely with and provided legal advice to various organizations within FDA, such as the Center for Drug Evaluation and Research (including the Office of New Drugs and the Office of Generic Drugs); the Center for Devices and Radiological Health; the Center for Biologics Evaluation and Research; the Center for Food Safety and Applied Nutrition (including the Office of Dietary Supplement Programs and the Office of Cosmetics and Colors); the Center for Veterinary Medicine; and the Center for Tobacco Products. He also worked with attorneys in the Department of Justice (including the Office of the Solicitor General and the Consumer Protection Branch).
James’ litigation work at FDA included defending the agency against Administrative Procedure Act challenges to FDA’s decisions regarding FDA-regulated products, bringing civil enforcement actions against FDA-regulated companies for violations of the Food, Drug, and Cosmetic Act (FDCA), and drafting amicus curiae and other filings advocating FDA’s positions on federal preemption and preclusion.
James also has over 12 years of private practice experience defending pharmaceutical and medical device manufacturers in products liability and mass tort litigation throughout the United States. This work has included briefing complex issues such as federal preemption, federal jurisdiction, admissibility of expert testimony under Daubert and Frye, punitive damages, and choice of law, as well as taking and defending fact and expert witness depositions.
James began his legal career in the Air Force Judge Advocate General’s (“JAG”) Corps, where he served as a trial prosecutor, trial defense counsel, and appellate counsel.