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The Food and Drug Administration and the U.S. Court of Appeals for the D.C. Circuit’s treatment of former Purdue Pharma executives is a reminder to executives and in-house counsel, particularly those in regulated industries, that they can face criminal liability and career-ending debarment for their company’s conduct, even if the executives did not personally participate in the conduct or even know about it
This year, both the Food and Drug Administration (FDA) and Department of Justice have repeatedly signaled to the pharmaceutical and medical device industries that they should expect an increase in the criminal prosecution of individuals for alleged violations of the food and drug laws, with the stated goals of increasing deterrence and greater compliance
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
