• Health Care Enforcement Review And 2017 Outlook: Part 1
  • January 30, 2017 | Author: Joanne S. Hawana
  • Law Firm: Mintz Levin Cohn Ferris Glovsky Popeo P.C. - Boston Office
  • Over the past year, clear trends have emerged in the U.S. Food and Drug Administration's enforcement activities. Enforcement arising alleged violations of the Federal Food, Drug and Cosmetic Act (FFDCA) can take many forms, including FDA advisory actions such as warning letters, adverse inspectional observations that can lead to specific administrative actions like product recalls or import detentions, and the pursuit of product seizures using express judicial tools, criminal convictions or civil settlements with the U.S. Department of Justice. Structurally, individual compliance offices within the FDA centers and regional offices can initiate enforcement activity against regulated industries, while the FDA Office of Criminal Investigations (OCI) has primary responsibility for criminal investigations conducted by the FDA and works closely with the DOJ in setting enforcement priorities for new cases.