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news.Medicis Pharmaceutical has agreed to pay $9.8 million to settle claims that the company promoted topical skin preparation Loprox in an off-label indication.
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The US and the whistleblowers, former Medicis sales representatives, alleged that Medicis urged doctors to use Loprox as a treatment for diaper rash. The use of Loprox, which is approved by FDA as a fungicide for patients over 10 years of age, is not approved for the treatment of diaper dermatitis and other skin disorders in children under 10.
Assistant attorney general, Peter Keisler, said: “Pharmaceutical companies need to know that they will be held accountable for off-label marketing schemes and other illegal activities that affect those programs.”
In the case against Medicis, the US alleged that the Medicaid program paid millions of dollars for Loprox prescriptions that would not have been reimbursed if government authorities had known that the prescriptions resulted from the company's off- label marketing campaign.
Medicis sold its pediatric sales unit in 2004. The civil settlement resolves claims brought by four former Medicis sales representatives. As a result of the settlement, the whistleblowers will collectively receive over $1 million as their statutory award.