Life Sciences Alert: FDA Releases Criteria for Responsible Officer Prosecutions


After almost a year of making clear its intention to target more individual executives when their companies allegedly violate the Federal Food, Drug, and Cosmetic Act (FDCA), the U.S. Food and Drug Administration (FDA) recently added a new chapter to its Regulatory Procedures Manual, outlining the criteria that it will consider in determining whether to target those individuals.

The FDA has had authority to prosecute responsible corporate officers since at least 1975 when the U.S. Supreme Court decided United States v. Park.1 Under the so called Park Doctrine, a responsible corporate official can be convicted of a misdemeanor based on his or her position of responsibility and authority to prevent and correct violations of the FDCA. Evidence that the individual participated in the alleged violations or even had knowledge of them is not necessary.

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