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GlaxoSmithKline Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies
The U.S. Food and Drug Administration (FDA) today announced that GlaxoSmithKline, Inc. (GSK), (through its U.S. subsidiaries SB Pharmco Puerto Rico, Inc., GlaxoSmithKline Puerto Rico Inc., and SmithKline Beecham Corporation), has signed a consent decree with FDA to correct manufacturing deficiencies at its Cidra, Puerto Rico facility.
FDA is concerned that GSK's violation of manufacturing standards may have resulted in the production of drug products that could potentially pose risks to consumers.
The Decree requires GSK to post a penal bond of $650,000,000 contingent upon GSK's either successfully reconditioning drugs seized in March 2005 or destroying them and paying costs to the government.
"The consent decree shows that FDA is serious about enforcing the manufacturing standards essential for safe and effective prescription drugs," said John Taylor, FDA Associate Commissioner for Regulatory Affairs. "It should also reassure the American people that we are doing everything we can to preserve the integrity of the American drug supply."
FDA's last inspection found Paxil CR tablets, approved to treat depression and panic disorder, could split apart. This deficiency could cause patients to receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains an active ingredient and does not have the intended controlled-release effect. Additionally, FDA found that some Avandamet tablets, used to treat Type II diabetes, did not have an accurate dose of rosiglitazone, an active ingredient in this product.
The FDA urges patients who use these two drugs to continue taking their medication and to talk with their health care provider about possible alternative products until the manufacturing issues have been resolved.
Under the terms of this decree the company has agreed to take measures to ensure that its Cidra facility and the two drugs, Paxil CR and Avandamet, fully comply with current Good Manufacturing Practice ( cGMP) requirements and to ensure that ongoing shipments have the quality attributes they are required to possess. The decree also requires that all corrections and the firm's compliance with cGMP requirements be certified by a third-party expert. Additionally, FDA will continue to monitor these activities through its inspections.
The Decree was presented yesterday for consideration by the United States District Court for the Eastern District of North Carolina. The Decree will take effect after it has been signed and entered by the Court.