(BOSTON) -- GlaxoSmithKline has agreed to plead guilty and pay a massive fine totaling $750 million to the federal government and the states to resolve allegations that the company caused false claims to be submitted to government health care programs for certain quantities of adulterated Kytril, Bactroban, Paxil CR and Avandamet.
The federal government argues that "GSK sold certain batches, lots or portions of lots of drugs," that possessed a strength, purity or quality "which fell materially below" that which was specified in the drugs' FDA applications. Consequently, the government says GSK "knowingly caused false and/or fraudulent claims to be submitted" to Medicaid and other federal health care programs.
"Adulterated drugs undermine the integrity of the FDA's approval process, can introduce substandard or ineffective drugs on to the market and, in the worst cases, can potentially put patients' health at risk," said Tony West, Civil Division Assistant Attorney General for the Department of Justice.
The Justice Department says this settlement is part of the government's ongoing effort to battle health care fraud under the False Claims Act. The law has helped the government to recover $4.2 billion in cases related to federal health care fraud since January 2009.
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