Off-label marketing: the competition for “biggest corporate fine” gets juicy

It is so important to admit when you’re wrong.  So here goes…

When I wrote that Astra-Zeneca paid the biggest corporate fine in American history ($520 million) for the off-label marketing of Seroquel, an atypical antipsychotic [I wrote that here]; I was wrong.

(NOTE: off-label marketing is the promotion of a drug – whether amongst patients, doctors, or other professionals – for uses that are not FDA-approved)


In early 2009, Eli Lilly paid an even bigger corporate fine — $1.4 billion — for the illegal off-label marketing of its star atypical antipsychotic, Zyprexa.  Off-label marketing is quite the trend these days; fines since 2004 total over $7 billion (and growing), yet pharmaceutical companies continue the practice unabated.

This chart contains a list of some of the worst offenders of recent years.  Note the surprising number of drugs with applications in the mental health field (both on- and off- label).  Actually, if you were to include the number of drugs which address psychosomatic symptoms of PTSD like auto-immune responses, fibromyalgia, and Irritable Bowel Syndrome, mental health drugs would be in the majority.

There’s an unwritten business plan.  They [pharmaceutical companies] are drivers that knowingly speed.  If stopped, they pay the fine, and then they do it again.

(Lon Schneider, University of Souther California professor and off-label marketing researcher)

This aptly titled Washington Post piece, “When drug makers’ profits outweigh penalties,” explores the issue in a bit more depth — essentially the fines amount to only a fraction of pharma’s profits, and seem to be operating more as bribes than fines.  I guess if you’re powerful enough, it pays to misbehave.  Never mind that others are paying with their lives.

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