“Responsible Corporate Officer”: Business Executives Face Strict Liability Under Novel Criminal Law Doctrine

In recent years, the federal government has aggressively prosecuted the allegedly improper distribution and promotion of drugs under the federal Food, Drug, and Cosmetics Act (FDCA) and the False Claims Act (FCA). As a result of these prosecutions, drug companies have agreed to civil and criminal settlements worth billions of dollars. Because federal officials suspect that improper distribution and promotion continues, some commentators predict more individual prosecutions under the FDCA’s “responsible corporate officer” doctrine. Under that doctrine, any corporate officer who has the authority and responsibility to prevent violations of the FDCA may be criminally liable for the violations, regardless of the officer’s knowledge or intent. Until the FDA issues guidance concerning the responsible corporate officer doctrine, the best, if not only, defense may be a good offense. That is, an aggressive compliance program with robust reporting mechanisms, led by senior corporate officers, may be the best means for avoiding liability.

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