NM Gets Back $194K for State Medicaid Program...Adulterated Drug Settlement Nets $750 Million Nationwide
Thursday, October 28, 2010
(ALBUQUERQUE)---Attorney General Gary King's Medicaid Fraud and Elder Abuse Division reports GlaxoSmithKline (GSK) will reimburse $194,443.53 to New Mexico's Medicaid program to settle allegations of selling adulterated Paxil CR,Avandamet, Kytril, and Bactroban.
The National Association of Medicaid Fraud Control Units joined the federal government to reach an agreement with pharmaceutical manufacturer GSK to pay the states and the federal government $600 million in civil damages and penalties for Medicaid and other federally-funded health care programs.
GSK subsidiary, SB Pharmaco of Puerto Rico, where the drugs were manufactured, has agreed to plead guilty to a felony violation of the U.S. Food, Drug, and Cosmetic Act and will pay $150 million in criminal fines and forfeitures.
The four drugs whose strength, purity and/or quality fell below the standards required by the FDA and their intended purposes are listed below:
Paxil CR: A controlled-release antidepressant that included split tablets, causing recipients to receive either product with no active ingredient and/or product with only the active ingredient layer and no controlled release mechanism;
Avandamet: A diabetes medication with tablets containing higher or lower amounts of the active ingredient than specified;
Kytril: An anti-nausea drug labeled as sterile but with some vials containing impurities; and,
Bactroban: Antibiotic ointments and creams that, in some packages, were contaminated with microorganisms.
GSK has agreed to the terms of a Corporate Integrity Agreementwith the Department of Health and Human Services Office of the Inspector General which will require scrutiny of GSK’s future manufacturing practices. The investigation that led to the current settlement grew out of a false claims action filed in 2004 in U.S. District Court in Massachusetts.