Ethex closed down after US court levies $27.6m in fines
pharmafile | March 8, 2010 | News story | Manufacturing and Production |Â Â Ethex, KV Pharma, manufacturing and productionÂ
Generic drugmaker Ethex Corp has been fined $27.6 million by a US District Court after pleading guilty to two felony charges that it failed to promptly inform the US Food and Drug Administration about serious manufacturing problems.
The company, a subsidiary of KV Pharmaceutical failed to alert the FDA about the production of out-of-specification, oversized tablets containing higher-than-intended amounts of active pharmaceutical ingredient.
The US Justice Department said that it had decided to press criminal charges against the company “given the seriousness of Ethex’s conduct and the risk it posed to consumers of its drugs”.
The company pleaded guilty to the charges and was fined $23.4 million and ordered to reimburse $2.3 million to Medicare and Medicaid for their drug purchases. A further $1.8 million has been forfeited to the US treasury.
KV Pharmaceutical has already said it will shut down the Ethex unit, which is based in St. Louis, Missouri.
The cases brought in front of the Justice Department centred on two medications, dextroamphetamine sulphate for attention-deficit hyperactivity disorder (ADHD) and the anti-arrhythmia agent propafenone, which were subject to a string of product recalls during 2008.
In the same year Ethex was also forced to recall three other products – extended-release formulations of isosorbide mononitrate and morphine sulfate as well as an immediate-release morphine product – on fears that out-of-spec tablets would deliver elevated levels of API.
“Even though they were aware of serious manufacturing problems concerning their oversized drugs, Ethex failed to notify the FDA as required by law,” commented assistant attorney general Tony West, who heads the Justice Department’s Civil Division.
KV Pharmaceutical is keen to put the matter behind it, and says the court settlement does not preclude it from trying to resume manufacturing of products.
The firm’s chairman, Terry Hatfield, said the company “remains focused on working alongside the FDA in accordance with our consent decree and demonstrating cGMP compliance so we can resume manufacturing and return our products to market”.
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