Justinian C. Lane, Esq.
Let Justice Be Done, Though the Heavens May Fall
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Justinian Lane's Blog

Justinian's Blog

Again, look how "ethical" pharmaceutical companies are

My new favorite site Pharmalot has coverage of another off-label marketing scandal: 

Medicis agreed to settle allegations the company violated the False Claims Act concerning claims submitted to Medicaid, the Justice Department announced today. The settlement resolves charges Medicis promoted a topical skin preparation, Loprox, for use on children under the age of 10, without FDA approval.

The US and four former Medicis employees alleged that from approximately November 2001 through April 2004, Medicis sales personnel targeted pediatricians, urging the docs to use Loprox as a treatment for diaper rash. Loprox, which is approved as a fungicide for kids over 10, isn't a “medically accepted indication” for the treatment of diaper dermatitis and other skin disorders in children under 10.

Source: Pharmalot: Medicis: $9.8M For Off-Label Marketing; Four Fomer Sales Reps To Share $1M

This is especially bad for two reasons.  First, off-label marketing is dangerous because the drugs have not been tested or approved by the FDA for this purpose.  Thus, Medicis put infants at risk just to make a buck.  Second, many of these prescriptions were paid for by Medicaid under false pretenses; because Medicaid won't approve prescriptions for off-label usage, the taxpayers got ripped off.

Medicis is settling for $9.8 million dollars.  A little over 1 million is going to the former employees who helped bring Medicis to justice.  Without the qui tam provisions of the False Claim Act, the odds are Medicis never would have been caught.  Since qui tam provisions are so effective in catching crooked corporations, I bet you won't be surprised to know that the gang at Overlawyered and much of the rest of the "reform" movement want to limit or abolish qui tam.