Criminal Prosecution of Medicis Pharmaceutical Corp.
Medicis Pharmaceutical Corp. agreed to pay the government $9.8 million to resolve allegations that the company promoted the use of a topical skin preparation, Loprox, for use in children under the age of 10, without approval of the FDA. The government alleged that from approximately November 2001 through April 2004, Medicis sales personnel targeted pediatricians and urged them to use Loprox as a treatment for diaper rash. The use of Loprox, which is approved by the FDA as a fungicide for patients over 10 years of age, is not a "medically accepted indication" for the treatment of diaper dermatitis and other skin disorders in children under age 10.
Source: HHS Health Care Fraud and Abuse Control Program, Annual Report for FY 2007
This article was posted on July 15, 2012.