Who Decides Your Fate in FDA Enforcement Matters?

John Fleder has written an FDLI Update article that sets forth the first ever published outline of the agencies and offices that get involved in decisions to commence FDA enforcement actions, such as FDA Warning Letters, seizures, injunctions (consent decrees), and criminal prosecutions. Mr. Fleder, who used to be the director of the office in the Justice Department that represents FDA in court proceedings, sets forth both FDA’s published and unpublished policies on these matters. This article presents a unique overview of the way that enforcement actions weave their way through the government bureaucracy. It is a roadmap for companies and their counsel to determine the people they need to speak with to influence decisions to bring or not bring enforcement actions.