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Policy: Law

Astellas Pharma settles False Claims Act allegations over Mycamine

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Health Care,Law,Legal Newsline

FRANKFORT, Ky. (Legal Newsline) – Kentucky Attorney General Jack Conway announced on Friday that Kentucky joined with other states and the federal government in a settlement with a pharmaceutical company that allegedly violated the False Claims Act.

Astellas Pharma US Inc. allegedly caused false claims to be submitted to state and federal healthcare programs related to its marketing and promotion of the drug Mycamine for pediatric use. Astellas allegedly promoted Mycamine, which is a sterile, lyophilized antifungal agent, for pediatric use even though it was not a medically accepted indication.

Federal healthcare programs only cover drugs for their medically accepted indications.

Between 2005 and 2010, the U.S. Food and Drug Administration approved Mycamine to treat adult patients suffering from serious and invasive infections caused by the fungus Candida, including infections in the abdomen, the blood and the esophagus. The drug was also approved to prevent Candida infections in adults undergoing stem cell transplants. Through June 2013, Mycamine was not approved to treat pediatric patients for any use.

A lawsuit was filed against Astellas in U.S. District Court for the Eastern District of Pennsylvania under the whistleblower provisions of the False Claims Act and similar state false claims statutes.

Under the terms of the settlement, the Kentucky Medicaid program will receive $6,956.70 and the federal government will recover $29,648.51 for its share of Kentucky-related damages.

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