Seth S. Ray is a highly experienced and well-respected Food and Drug Administration (FDA) regulatory attorney. His practice focuses on providing advice on FDA issues to Dechert’s corporate and securities, product liability and mass torts and intellectual property practice groups, as well as providing FDA regulatory counseling to firm clients.
Mr. Ray has particular expertise in a range of FDA regulatory issues, involving drugs, biologics and medical devices (e.g., drug approval requirements, drug labeling, prescription drug and device advertising/promotion, clinical study issues, drug safety, biologics regulation and FDA enforcement/compliance). He is a recognized expert in the advertising/promotion of prescription drugs and devices and has served as an expert witness on this and other FDA regulatory issues in several litigations.
Serving as an attorney and manager in the Office of the Chief Counsel at FDA for 24 years, Mr. Ray has significant government experience. He initially served as an Associate Chief Counsel for Enforcement and then as Associate Chief Counsel for Drugs, providing advice to the Center for Drug Evaluation and Research (CDER) and other parts of FDA on a variety of drug matters. Mr. Ray went on to serve as Associate Deputy Chief Counsel for Drugs and Biologics, managing the drugs and biologics attorney counseling teams and serving as senior counsel on all prescription drug advertising/promotion matters. He also was a Senior Advisor/Regulatory Counsel in FDA’s Office of Prescription Drug Promotion (OPDP); an FBI Special Agent; a Trial Attorney in the U.S. Department of Justice; and as Assistant State’s Attorney in Florida.
Before joining Dechert, Mr. Ray served as FDA regulatory counsel to two law firms.
During his years of government service, Mr. Ray received numerous honors and awards from FDA and the U.S. Department of Health and Human Services (DHHS), including:
- From FDA – FDA Award of Merit; several FDA Commissioner’s Special Citations
- From DHHS – Superior Achievement Award; Secretary’s Award for Distinguished Service
- FDA Proposes to Indefinitely Delay Obama Administration Amendments to FDA Regulations on Intended Use - Westlaw Journal Pharmaceutical (February 13, 2018)
- FDA Allows Off-Label Healthcare Economic Discussions . . . Is There More To Come - STAT News (June 29, 2018)
- Dickinson College, B.A., 1977, magna cum laude, President of the Student Senate
- Emory University School of Law, J.D., 1980
- District of Columbia