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Actavis Hails U.S. Supreme Court Decision in Labeling Cases
Date:6/23/2011

MORRISTOWN, N.J., June 23, 2011 /PRNewswire/ -- Actavis applauds the U.S. Supreme Court's decision in the Mensing and Demahy cases as an important step forward for consumer safety and the continued availability of affordable generic medicines.

By a 5-4 majority, the court rejected arguments that generic-drug manufacturers should be subject to state lawsuits alleging "failure to warn" over the contents of their products' labels. Justice Clarence Thomas authored the majority opinion, which concluded that federal law requiring the labels on generic products to be identical to that of their brand counterparts, and prohibiting generic manufacturers from making changes to them, preempted such cases.  

Actavis Inc. CEO Doug Boothe called the decision "an important and necessary step by the Supreme Court to clarify the proper interpretation of the regulations governing pharmaceutical labeling."

"A consistent drug-labeling standard, overseen by the federal Food and Drug Administration, as contemplated by the federal regulations is absolutely essential to protecting the safety and wellbeing of the of American consumers who rely upon generic medications for their health and quality of life," he said. "This ruling furthers meaningful consumer protection while also safeguarding against lawsuits that threaten the availability of safe and affordable pharmaceutical products by misconstruing the labeling responsibilities of generic manufacturers."

The ruling covered three separate cases that were consolidated for argument before the court in March: Actavis v. Mensing, Pliva v. Mensing and Actavis v. Demahy. The key question centered on whether consumers may sue generic drug manufacturers in state court over the contents of product labels that the companies do not control.

Boothe believes a necessary next step is for Congress to take guidance from the decision and address ambiguities in existing laws to confirm the FDA's sole authority to regulate the contents of medication labels.

"The 1980s regulatory structure that governs our industry is incompatible with the realities of the 21st century healthcare marketplace," he said. "Congress must modernize the Food, Drug and Cosmetic Act to reflect these realities, and Actavis welcomes any opportunity to work with members of Congress and the FDA to accomplish this important objective."

About Actavis Inc.

Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one third of Actavis' sales are generated in North America, Actavis' single largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing and packaging facilities in Elizabeth, NJ; a manufacturing facility in Lincolnton, NC; and research and development facilities in Owings Mills, MD and Sunrise, FL. Please visit www.actavis.us for more information.


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