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Amgen Anemia Drug Lawsuit Dismissed

Posted by Chrissie Cole
Monday, December 22, 2008 7:03 PM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Amgen, Epogen, Aranesp, Drug Products, Anemia

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IMAGE SOURCE: © Amgen Inc.

A federal court dismissed a lawsuit against Amgen Inc., alleging illegal promotion of anemia drugs, saying the case should have been made to regulators not federal court.

Seven health-benefit plans brought the case against the biotechnology giant, along with two dialysis clinic operators, claiming the company engaged in “off-label” marketing of Aranesp and Epogen, both anemia drugs.

Off-label marketing refers to the marketing if drugs for uses other than those that are approved by the U.S. Food and Drug Administration (FDA).

The drugs, known as erythropoiesis-stimulating agents, or ESAs, increase red blood cells needed to fortify the patient's blood.

The U.S. District Court for the Central District of California, last week, dismissed the claims and the litigation on the ground that they constituted an improper attempt to privately enforce the Food, Drug and Cosmetics Act.

In order to pursue the complaint, the court said the plaintiffs needed to point to specific misrepresentations made by the defendants. The complaint was filed under the federal racketeering statute and California’s consumer fraud laws.

Anemia is a condition in which the number of red blood cells or the amount of hemoglobin (a protein that carries oxygen) in red blood cells is below normal. The blood of anemic patients is therefore oxygen depleted, leading to fatigue, weakness, and in severe cases, stroke and heart attack. #


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