The U.S. Food and Drug Administration ("FDA") recently set forth, in its Regulatory Procedures Manual for FDA personnel, criteria for when it would refer a matter for potential prosecution under the Park doctrine. In essence, the Park doctrine provides for criminal liability (first-time misdemeanor and possible subsequent felony) under the federal Food, Drug and Cosmetic Act ("FDCA") without proof that a corporate official acted with intent or even negligence.
Prosecution under the Park doctrine is possible even if the responsible corporate official lacked knowledge or did not participate in the specific offense. The FDA stated it would consider...
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