The global settlement involving the federal government and the states totals $750 million and a guilty plea for a felony violation of the U.S. Food, Drug, and Cosmetic Act
Attorney General John Kroger today announced that Oregon will receive $5.9 million in a pharmaceutical settlement with GlaxoSmithKline over adulterated drug allegations.
“Failing to meet drug safety standards is unacceptable,” said Keith Dubanevich, Chief of Staff and Special Counsel to Attorney General Kroger. “We will not hesitate to take action to protect Oregonians.”
The settlement requires Glaxo to pay the states and the federal government $600 million in civil damages and penalties for Medicaid and other federally-funded health care programs. Additionally, Glaxo subsidiary SB Pharmaco has agreed to plead guilty to a felony violation of the U.S. Food, Drug, and Cosmetic Act and must pay $150 million in criminal fines and forfeitures.
Oregon will receive $5,887,882.86 under the agreement.
The national federal and state civil settlement resolves allegations of poor manufacturing practices in a Glaxo facility located in Cidra, Puerto Rico. Oregon alleged that Glaxo knowingly manufactured, distributed and sold four products between 2002 and 2005 – Paxil CR, Avandamet, Kytril and Bactroban – whose strength, purity and/or quality fell below the standards required by the FDA.
Paxil CR is a controlled-release antidepressant that included split tablets, causing recipients to obtain either product with no active ingredient and/or product with only the active ingredient layer and no controlled release mechanism.
Avandamet is a diabetes medication with tablets that contained higher or lower amounts of the active ingredient than specified.
Kytril is an anti-nausea drug that was labeled as sterile, but some vials contained impurities.
Bactroban is in antibiotic ointment and cream that, in some packages, were contaminated with micro-organisms.
This settlement agreement reimburses the federal government and the participating states for the amounts paid by the Medicaid program as a result of Glaxo’s conduct. Additionally, Glaxo has agreed to the terms of a Corporate Integrity Agreement with the Department of Health and Human Services, Office of the Inspector General, which will require scrutiny of Glaxo’s future manufacturing practices.
Attorney General John Kroger leads the Oregon Department of Justice. The Department’s mission is to fight crime and fraud, protect the environment, improve child welfare, promote a positive business climate, and defend the rights of all Oregonians.
Contact:
Tony Green, (503) 378-6002 tony.green@doj.state.or.us