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GPhA Pleased with Supreme Court Ruling in Pliva v. Mensing

WASHINGTON, D.C. (JUNE 23, 2011) – The Generic Pharmaceutical Association (GPhA) today issued the following statement regarding the U.S. Supreme Court’s ruling in the consolidated cases Pliva v. Mensing, U.S., No. 09-993, Actavis Elizabeth LLC v. Mensing, U.S., No. 09-1039, and Actavis Inc. v. Demahy, U.S., No. 09-1501.

“GPhA believes the High Court has appropriately recognized that current law leaves generic manufacturers with no alternative but to make certain that its products have labeling that is identical to the labeling of the reference brand product,” GPhA Executive Director Bob Billings said. “As the Supreme Court recognized in this decision, assessing liability based on label content that is beyond the control of the generic manufacturer places the generic manufacturer in the impossible position of defending the content of a label that they are required by law to use but prevented by law from changing.”

“When used as directed by FDA approved labeling, generic prescription drugs provide the same safety and efficacy as the counterpart brand product and patients can expect to same therapeutic benefit,” Billings said. “The generic pharmaceutical industry will continue to scrupulously comply with all laws and regulations to provide patients with the safe, effective and affordable medications they have come to rely on.”

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 75 percent of the prescriptions dispensed in the U.S. but consume just 22 percent of the total drug spending. Additional information is available at gphaonline.org.

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