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US FDA May Clarify When Execs Can Be Criminally Prosecuted Under Park Doctrine

 
• By Sue Sutter

Agency is considering whether a breach of duty to act or correct violations under the Food, Drug and Cosmetic Act must occur before criminal charges are brought, Chief Counsel Rebecca Wood says; clarity on FDA's view of 'vicarious criminal liability' would be welcome news to the pharma industry and suggests an early priority for the agency's new top lawyer.

The US FDA is considering clarifying when it will pursue criminal charges against individuals in a supervisory role for Food, Drug and Cosmetic (FD&C) Act violations committed by subordinates, the agency's top lawyer said Dec. 6.

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