FDA Recommends Increased Criminal Prosecutions of Responsible Corporate Officials; Important Questions Left Unanswered


The Food and Drug Administration (FDA) has announced its intention to push for an increase in the use of criminal misdemeanor prosecutions of individual “responsible corporate officials.” This change in enforcement policy suggests that executives or managers in the pharmaceutical, medical device, and other FDA-regulated industries may be targeted for criminal charges under the Food, Drug, and Cosmetic Act (FDCA) even if they played no role in the alleged misconduct.

Under two landmark U.S. Supreme Court cases, United States v. Dotterweich and United States v. Park, a corporate official can be convicted of a misdemeanor violation of the FDCA without personally engaging in wrongdoing, or even knowing about another person’s violation of the statute, provided the official had the responsibility or authority to prevent or correct the FDCA violation, but failed to do so. This doctrine departs from standard principles of criminal law by imposing strict, vicarious criminal liability on a person who has neither engaged in misconduct nor exhibited criminal intent. In recent years, misdemeanor FDCA prosecutions of executives based solely on an executive’s relationship of responsibility over others in the company have been rare, although notable exceptions exist. Executives convicted of misdemeanor violations of the FDCA can face imprisonment, substantial fines, and exclusion from participation in federal health care programs.

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