Astellas settles with US DoJ over Mycamine marketing

The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and off-label promotion of the drug Mycamine (micafungin sodium) for pediatric use, the US Justice Department announced yesterday.

“The FDA’s drug approval process requires companies to demonstrate the safety and efficacy of their products,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart Delery. “The Justice Department will hold accountable pharmaceutical companies that skirt these rules and seek to bill federal health care programs for uses of drugs that are not reimbursable.”

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.