The Pharmaceutical company Astellas Pharma US, Inc. has agreed to pay the United States a total of $7.3 million to resolve allegations that it violated the False Claims Act by illegally marketing and promoting the drug Mycamine® for pediatric use and to pediatric institutions.
The settlement resolves allegations brought in a whistleblower action filed in the Eastern District of Pennsylvania in March 2010 under the False Claims Act, which permits private citizens to bring lawsuits alleging violations of the Act on behalf of the United States and to share in any recovery. The settlement resolves claims that, between 2005 and 2010, Astellas knowingly marketed and promoted the sale of Mycamine® for pediatric use, which was not a medically accepted indication and, therefore, not covered by federal health care programs. During this timeframe, the FDA approved Mycamine® to treat adult patients suffering from serious and invasive infections caused by the fungus Candida, including infections in the esophagus, the blood and the abdomen, and to prevent Candida infections in adults undergoing stem cell transplants. Up until June 2013, however, Mycamine® was not approved to treat pediatric patients for any use.