The GAO recently issued a report entitled “Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations,” at the request of Senate Finance Committee Ranking Republican Charles Grassley. The report focuses on FDA monitoring of the FDA’s Office of Criminal Investigations (OCI), which investigates individuals and companies external to FDA, and the Office of Internal Affairs (OIA), which investigates allegations of FDA employee misconduct. FDA has responded to the criticism in the report in a letter to Sen. Grassley, stating that an internal committee has recommended that the FDA and OCI “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool.” The statute giving FDA its authority is a strict liability statute, which means a company’s top executive can be found individually criminally responsible for a violation of FDA laws and regulations even though the executive did not participate in the violation, was not aware of the violation, and/or did not act with criminal intent or even negligence.
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GAO report calls for increase in FDA criminal prosecutions of company executives
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