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Medicis Pharmaceutical settles off-label marketing case for $9.8 million

Medicis Pharmaceutical Corp. of Scottsdale, Ariz., will pay the United States $9.8 million to settle allegations that the company violated the False Claims Act by promoting the use of a topical skin preparation, Loprox, for use on children under the age of 10, without approval by the Food & Drug Administration (FDA). The settlement agreement was announced by the U.S. Dept. of Justice.

The U.S. and four whistleblowers alleged in a qui tam case that from approximately November 2001 through April 2004, Medicis sales personnel pushed pediatricians to use Loprox as a treatment for diaper rash even though it is not a “medically accepted indication” for the treatment of diaper dermatitis and other skin disorders in children under 10.

The Food, Drug & Cosmetic Act prohibits pharmaceutical companies from marketing or promoting a drug for uses that the FDA has not approved, a practice known as “off-label marketing”. In the case against Medicis, the United States 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 government has awarded the whistleblowers, former Medicis employees, a total of $1.07 million. Under the qui tam provisions of the False Claims Act, private parties can file a lawsuit on the government’s behalf if the government is being defrauded and are entitled to a portion of the amount the government recovers.


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