Office of the Attorney General
Attorney General Conway Announces $40 Million Multi-state Agreement with GlaxoSmithkline and SB Pharmco
Attorney General Jack Conway, joined by 37 other state attorneys general, announced today a $40.75 million settlement with GlaxoSmithkline, LLC (GSK) and SB Pharmco Puerto Rico, Inc. (SB Pharmco) over alleged substandard manufacturing processes. Kentucky's portion of the settlement is $818,194.
In a complaint filed today along with the settlement agreement, Attorney General Conway alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed certain lots of Kytril (a sterile drug used to prevent nausea and vomiting caused by cancer chemotherapy and radiation therapy), Bactroban (an antibiotic ointment used to treat skin infections), Paxil CR (the controlled release formulation of the popular antidepressant drug, Paxil) and Avandamet (a combination Type II diabetes drug). The complaint alleged the drugs were adulterated because the manufacturing processes used to produce these lots were substandard.
"Companies that market pharmaceuticals and over-the-counter medicines in Kentucky are essentially representing that those products were manufactured using good manufacturing practices," General Conway said. "My office is committed to investigating and enforcing the law against companies who attempt to peddle poorly manufactured medicines."
GSK and SB Pharmco are no longer manufacturing drugs at their Cidra facility, which has been closed since 2009. SB Pharmco pled guilty in 2010 to introducing adulterated products into trade or commerce as part of a settlement of federal charges relating to manufacturing practices at the Cidra plant in 2003 and 2004.
As a result of today's settlement with the attorneys general, GSK and SB Pharmco are enjoined from making false, misleading or deceptive claims regarding the manufacturing of all drugs formerly manufactured at the Cidra facility regardless of where these drugs are now produced. In addition, the companies must not misrepresent those drugs' characteristics, or cause likelihood of confusion or of misunderstanding about the way in which they are manufactured.
Consumers should note that the batches of drugs found by the federal government to have been adulterated were recalled years ago and are past their expiration dates. If consumers do have concerns they should contact their health care provider.
Illinois Attorney General, Lisa Madigan and Oregon Attorney General, John Kroger led the investigation into GSK and SB Pharmco's manufacturing practices. The Attorneys General of the following states and the District of Columbia participated in the settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.