Canada's Version of the Responsible Corporate Officer Doctrine: Can Officers Be Held Responsible for Pharma Violations?

In March 2010, the United States Food and Drug Administration (FDA) announced its intention to rely more heavily on the "responsible corporate officer" (RCO) doctrine to prosecute individuals for violations of the federal Food, Drug and Cosmetic Act (FDCA). The RCO doctrine, also known as the "Park Doctrine," imposes personal liability on the officers and directors of companies for violations of food and drug laws. It provides that a responsible corporate official can be charged with a misdemeanor offense even if the official did not know about or participate in the specific offense. This article briefly outlines this U.S. doctrine and contrasts it with the approach in Canada.

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