The Federal Food, Drug, and Cosmetic Act is enforceable through criminal prosecution, injunction proceedings, civil money penalties, and a variety of administrative actions, as well as through the False Claims Act and general federal criminal statutes. Arnold & Porter LLP has significant experience both in the courtroom and in helping avoid the courtroom altogether through effective early intervention to prevent inappropriate or unnecessary enforcement actions. Our attorneys are experienced advocates before the FDA, the DOJ, and other federal agencies with related jurisdiction, including the Drug Enforcement Administration, the Inspector General of Health and Human Services (HHS), and the CPSC, as well as state regulatory agencies. The firm also has advised clients during intensive government investigations and audits. We have, for example, successfully defended several manufacturers of medical devices in so-called Section 305 hearings that resulted either in no criminal referral by the FDA or in no subsequent action by the DOJ.