Off-Label Marketing: Fines and Industry Exclusion
It is important to weigh enforcement risks with perspective. The Justice Department’s biggest FCPA enforcement year was approximately $1.4 billion in 2010. The Justice Department doubled that amount in the off-label marketing prosecution of GlaxoSmithKline (GSK) which totaled $3 billion in one case, which consisted of a $1 billion criminal fine and $2 billion in civil penalties. GSK paid these penalties for off-label promotion of...