Astellas pays $7.3 million to settle off-label pharma case

by Ben Vernia | April 21st, 2014

On April 16, the Department of Justice announced that Illinois-based Astellas Pharma US had settled a suit, originally filed by a former sales representative, that the company promoted its drug Mycamine for off-label uses. According to DOJ’s press release:

Pharmaceutical company Astellas Pharma US Inc. will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use, the Justice Department announced today. Astellas Pharma US Inc., located in Northbrook, Ill., manufactures and sells pharmaceutical drugs, including Mycamine.

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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 time period, 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. From 2005 through June 2013, however, Mycamine was not approved to treat pediatric patients for any use.

As a result of today’s $7.3 million settlement, the federal government will receive $4.2 million, and state Medicaid programs will receive $3.1 million.

DOJ announced that the whistleblower will receive $708,852 (presumably of the federal portion, a 16.8% relator’s share).

Disclosure: While an attorney at Covington & Burling, I represented Astellas in an unrelated matter.

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