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FDA Prosecution Criteria For “Responsible” Execs Includes Seriousness, Obviousness Of Violations

Executive Summary

Almost a year after signaling its intent to target more individual executives with misdemeanor prosecutions when their companies have broken the law, FDA has published its criteria for pursuing such cases.

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Park Doctrine’s Use Should Hinge On Individual’s Knowledge Of Wrongdoing, Prosecutor Says

Application of the Park doctrine to hold corporate officers strictly liable should depend upon an individual’s knowledge of wrongdoing committed under the Food, Drug and Cosmetic Act, Assistant U.S. Attorney for the District of Massachusetts Sara Bloom tells a compliance conference.

Park Doctrine Could Be Limited By Upcoming Cases, Attorney Argues

As penalties increase under responsible corporate officer doctrine, attorney Allison Burroughs, a partner at Nutter McClennen & Fish, says to expect increased scrutiny.

Former KV Pharmaceutical CEO Sentenced To 30 Days In Jail

Marc Hermelin pleads guilty to distributing oversized morphine sulfate tablets; he may be first pharma exec to be jailed for healthcare fraud.

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