Tags: GlaxoSmithKline | Settle | Manufacturing | Probe | drugs | adulterated

Glaxo Settles Defective-Drugs Claims for $750 Million

Tuesday, 26 Oct 2010 03:05 PM

GlaxoSmithKline PLC settled a U.S. government false claims suit over the sale of defective drugs for $750 million.

The lawsuit was initially filed in 2004 by Cheryl D. Eckard, a former global quality assurance manager for the U.K.’s biggest drugmaker. The London-based company said in July it agreed in principle with the U.S. to pay 500 million pounds ($791 million) to settle the investigation. The government confirmed the settlement today in a statement.

The pharmaceutical manufacturer was accused in court papers of selling tainted drugs under false pretenses. The medicines, which were manufactured at defendants’ plant in Cidra, Puerto Rico, were misidentified as a result of product mix-ups, according to court papers filed in Boston federal court under the U.S. False Claims Act.

“The false claims arose out of chronic, serious deficiencies in the quality assurance function at the Cidra plant and the defendants’ ongoing serious violations of the laws and regulations designed to ensure the fitness of drug products for use,” the government said in court papers.

The drugs affected by the defendants’ conduct include Paxil, Paxil CR, Avandia, Avandamet, Coreg, Bactroban, Abreva, Cimetidine, Compazine, Denavir, Dyazide, Thorazine, Stelazine, Ecotrin, Tagamet, Relafen, Kytril, Factive, Dyrenium and Albenza, according to court records.

“We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice (cGMP) requirements and with GSK’s commitment to manufacturing quality,” said PD Villarreal, a Glaxo senior vice president, in an e-mailed statement.

The U.S. Food and Drug Administration in 2005 seized some Paxil CR lots after it was discovered that the pills sometimes split inappropriately, according to court papers. Some of the pills lacked an active ingredient.

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