In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high: $1.4 billion—yes, billion—paid in criminal and civil penalties to the United States.

Sometimes, however, the conduct of entities evinces such a complete disregard for the health and safety of the public that a criminal response is necessary.

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