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Medicis: $9.8M For Off-Label Marketing; Four Fomer Sales Reps To Share $1M
May 9, 2007

Source: Pharmalot
If you don’t understand what off-label marketing is about, in a nutshell, it is extremely dangerous because the products were not approved, nor tested, by the FDA, for the purposes for which it gets labeled.

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. [more]


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