Seth S. Ray

Of Counsel
1775 Pennsylvania Avenue NW
Suite 1000
Washington, DC 20006
202.677.4926 phone
202.677.4927fax

Seth S. Ray is of counsel in the Food and Drug Group/Healthcare Practice. He served as an attorney and manager in the Office of Chief Counsel at FDA (OCC) for 24 years. First, as an Associate Chief Counsel for Drugs, providing advice to the Center for Drugs (CDER) and other parts of FDA on a variety of drug matters, and then 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 spent 2 years in FDA’s Office of Prescription Drug Promotion (OPDP), serving as Senior Advisor and Regulatory Counsel, providing OPDP with legal and policy advice on significant guidance documents, enforcement actions, and other complex matters.

Mr. Ray focuses his practice on FDA regulatory issues. He has particular expertise on drug approval issues, prescription drug labeling, prescription drug advertising/promotion, drug safety, the regulation of clinical trials, and compliance issues. He has also served as a consultant and expert witness on FDA regulation matters related to the advertising and promotion of prescription drugs.

Prior to joining AGG, he practiced law at O’Melveny & Myers.

Corporate & Government Experience

  • Associate Chief Counsel for Drugs and Associate Deputy Chief Counsel for Drugs and Biologics, Office of the Chief Counsel (OCC), FDA
  • Senior Advisor and Regulatory Counsel, Office of Prescription Drug Promotion (OPDP), FDA
  • Trial Attorney, Tax Division, Criminal Section, United States Department of Justice
  • FBI Special Agent, Florida and Tennessee
  • Assistant State Attorney (ASA), Broward County, Florida