AG Gansler: Astellas Pharma US Inc. Pays $7.3 Million to Resolve False Claims Act Allegations Related to Marketing of Antifungal Agent
Company promoted Mycamine to treat children without FDA approval
Baltimore, MD (July 25, 2014) - Attorney General Douglas F. Gansler announced today that Maryland, joined by multiple states and the federal government, has settled allegations that Astellas Pharma US, Inc. (Astellas) caused false claims to be submitted to federal and state health care programs in connection with its marketing and promotion of the drug Mycamine for pediatric use. Mycamine is a sterile, lyophilized (freeze-dried) antifungal agent that was approved only for use by adults. As part of the settlement, Astellas will pay $13,583.96 to the Maryland Medicaid program.
"We can't be aggressive enough when it comes to protecting children," said Attorney General Gansler. "This settlement takes aim at companies that defy safety regulators and create a hazardous marketplace for consumers by marketing drugs for unapproved uses."
The settlement resolves allegations 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 period, the Food and Drug Administration approved Mycamine to treat adults suffering from serious and invasive infections caused by the fungus Candida. The ailments included infections of the esophagus, blood and abdomen, and to prevent Candida infections in adults undergoing stem cell transplants. From 2005 through 2010, however, Mycamine was not approved to treat pediatric patients for any use.
The allegations resolved by this settlement were originally raised in a lawsuit filed against Astellas in the United States District Court for the Eastern District of Pennsylvania under the qui tam, or whistleblower, provisions of the False Claims Act and parallel state false claims statutes.
A National Association of Medicaid Fraud Control Units (NAMFCU) team participated in the investigation and conducted the settlement negotiations with Astellas on behalf of the states. In making the announcement, Attorney General Gansler thanked Medicaid Fraud Control Unit Deputy Director Shelly Marie Martin, Assistant Attorney General Anna Schultz Kelly, and Chief Auditor Ruth Jarrell for their work on this case.