Thirty-eight states settle with GlaxoSmithKline

Bryan Cohen Jun. 23, 2011, 2:00pm


WASHINGTON (Legal Newsline) - Thirty-eight states announced a $40.75 million agreement on Thursday with GlaxoSmithKline and SB Pharmco over substandard products.

The agreement that resolves allegations that GlaxoSmithKline LLC and a subsidiary of Glaxo's parent company used substandard drug manufacturing processes, producing adulterated drugs.

"Cutting corners to turn a profit is unacceptable," Mary Williams, Oregon's deputy attorney general, said.

The allegations involve a manufacturing facility in Cidra, Puerto Rico, which was owned by SB Pharmco, a subsidiary of GlaxoSmithKline's parent company that was the largest production facility of GlaxoSmithKline products worldwide in 2001.

The complaint alleged that from 2001 to 2004, the companies failed to comply with federal manufacturing guidelines in the production of prescription drug brands Kytril, Paxil, Bactroban and Avandament.

The companies are accused of violating state consumer protection law by manufacturing and distributing for use certain lots of drugs that were adulterated due to substandard manufacturing processes.

The agreement prohibits GlaxoSmithKline and SB Pharmco from making any misleading, false or deceptive claims about the manufacturing of all drugs formerly produced at the Cidra facility, regardless of where they are now manufactured. The companies may not misrepresent any characteristics of their drugs or cause the likelihood of misunderstanding or confusion about the way in which they are manufactured.

The companies are no longer manufacturing prescription drugs at the Cidra facility, which has been closed since 2009.

Current users of the four medications need not worry as all adulterated batches have been recalled for multiple years and/or the expiration date of the drug is past.

Consumers with questions about the drugs should consult their health care provider.

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