Johnson & Johnson McNeil-PPC Consent Decree and Permanent Injunction
The recent Consent Decree and Permanent Injunction against McNeil-PPC and two of its Vice Presidents recalled an article from March 2010 re: “FDA Recommends Increased Criminal Prosecutions of Responsible Corporate Officials…”. The initial paragraph is enclosed below. To obtain the entire article, please copy the Web site below. Please consider how the FDA’s activities may impact all Quality Management personnel.
FDA Recommends Increased Criminal Prosecutions of Responsible Corporate Officials; Important Questions Left Unanswered
“The Food and Drug Administration (FDA) has announced its intention to push for an increase in the use of criminal misdemeanor prosecutions of individual “responsible corporate officials.” This change in enforcement policy suggests that executives or managers in the pharmaceutical, medical device, and other FDA-regulated industries may be targeted for criminal charges under the Food, Drug, and Cosmetic Act (FDCA) even if they played no role in the alleged misconduct.”