The Food and Drug Administration (FDA) has called for more frequent prosecutions of "responsible corporate officers" under the federal Food, Drug and Cosmetic Act. Under the responsible corporate officer (RCO) doctrine, also known as the Park doctrine, senior individuals in FDA-regulated companies can be charged with strict-liability misdemeanor offenses even when the individual did not participate in, or even know about, the underlying misconduct. The FDA's announcement is consistent with the Department of Justice's increased use of RCO prosecutions of pharmaceutical and medical device executives. Individuals convicted of strict-liability misdemeanor offenses face imprisonment, substantial criminal fines, debarment and, potentially, lengthy exclusions from federal health programs that have the practical effect of barring the individuals from working in the health care industry. The management of FDA-regulated companies should understand the RCO doctrine and the risks it poses to individuals at many levels of the company, and should implement rigorous corporate ethics and compliance programs.
