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GlaxoSmithKline to Pay $40.75 Million for Substandard Drug Manufacturing

Drug manufacturer GlaxoSmithKline has agreed to pay $40.75 million to settle cases brought by 37 states and the District of Columbia alleging that Glaxo used substandard manufacturing processes at a former plant in Puerto Rico. Reports from The Wall Street Journal stated that the company did not admit any liability but settled the case to avoid the expense and uncertainty of protracted litigation, according to a company spokesperson.

Some Tablets Produced Contained Inappropriate Amounts of Active Ingredient

The plant in question is located in Cidra, Puerto Rico, and was closed in 2009. The company sold the plant the following year. Glaxo was required to bring it into compliance with company and FDA standards prior to the closing. From 2001 to 2005 the Cidra plant manufactured Kytril, a nausea treatment; antibiotic ointment Bactroban; antidepressant Paxil; and Avandamet, a diabetes drug. A prior investigation revealed that some of the tablets produced at the Cidra plant contained inappropriate amounts of active ingredient. The investigation also revealed that some of the tablets from the plant would split apart.

Other Allegations

Other allegations included the use of contaminated water and an air-conditioning system that allowed cross-contamination between different products. Workers were also allegedly required to hand scrape the inside of tanks containing Bactroban and contaminated the ointment with bacteria while doing it. Reports of workers selling rejected product to Latin American countries also surfaced. Last October, Glaxo pleaded guilty in a criminal case brought by the United States for manufacturing deficiencies. The company also paid a fine of $750 million to settle the U.S. case. The problems with the plant were brought to the authorities' attention by company Quality Assurance Chief Cheryl Eckard, who eventually lost her job, but received a $96 million reward for blowing the whistle on the operations at the Cidra plant.

The Cidra plant was the subject of a "60 Minutes" program earlier this year. The program implied that patients were injured from defective drugs produced at the plant. Glaxo disagreed with the program in a subsequent press release and stated that no evidence of patient harm due to the adulterated drug batches had been found. The company also denied that it fired anyone for reporting the problems with the Cidra plant.

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