Article preview from "The Gray Sheet" - September 29, 2010
The government's chief litigators are not mincing words: They plan to hold more health care execs personally responsible for crimes at their firms.
Justice Dept, Inspector General To Target Individuals In Off-Label Cases
Article preview from "The Gray Sheet" - September 29, 2010
By Jessica Bylander
The Department of Justice and Department of Health and Human Service's Office of Inspector General will join FDA in shifting the focus to individual liability in cases such as off-label promotion of devices and drugs.
FDA plans to more aggressively pursue misdemeanor prosecutions of CEOs, managers and other execs under the long-established but sporadically used "responsible corporate officer doctrine" (1 'The Gray Sheet' April 19, 2010).
DOJ and OIG are on board, and have devised some new tools to increase personal accountability for off-label marketing, according to department reps who spoke at the recent Food and Drug Law Institute conference on advertising and promotion in Washington, D.C.
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