The price drug companies pay for illegally marketing drugs for off-label (tnat is, non-FDA-approved) uses just got higher. Such off-label pushing has been a growing problem the past few years, as drug companies sought to expand the use and thus the profit from established drugs. Doctors are free to prescribe drugs for off-label uses — but companies aren’t allowed to recommend or urge such use, as such use hasn’t, by definition, been vetted at the FDA and so should be a doctor call, not the drug companies. Nevertheless, companies have indulged heavily in the practice.
This fine might be heavy enough to seriously discrouage it. The fine is over a third of what the total sales of the reported $3.5B the drug (Zyprexa) generated. Not clear to me if anyone knows what portion of that $3.5 came from off-label use. But it seems doubtful it was $1.4B, which is what they’re paying to settle the case.
I’ll comment in another post on how this story reflects an interesting, and I would say promising, intersection of the powers of the mainstream and new (blogging) press.