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Pharmaceuticals / Inspections and Audits

FDA Considers ‘Vicarious’ Criminal Liability for Senior Company Officials

Dec. 15, 2017
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The FDA’s chief counsel said the agency is examining the legal circumstances where a company’s senior personnel and management could be held not only civilly responsible, but also criminally responsible for the actions of those working under them.

Rebecca Wood, speaking at the FDLI Enforcement, Litigation, and Compliance Conference, said many questions have been raised over so-called “vicarious” criminal liability — where a person, who did not commit wrongdoing, could be found liable for the acts of others at the company.

In addition, the FDA’s lawyers and investigators are considering whether a breach of a duty to act or to correct violations must occur before criminal charges are brought.

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