Amgen’s Misbranding Case Resolution Delayed by U.S. Judge

A federal judge delayed his decision on whether to approve an agreement to resolve a criminal charge against Amgen Inc. for misbranding its anemia drug Aranesp.

The proposed settlement calls for the company to pay $150 million in criminal penalties. Amgen, the world’s largest biotechnology company, also would pay $612 million to settle civil cases over its marketing practices, prosecutors said.

“I’m going to reserve and get back to you,” U.S. District Judge Sterling Johnson told prosecutors in a hearing today in Brooklyn, New York. The judge said he may decide later today or tomorrow.

U.S. prosecutors alleged the company promoted Aranesp for uses not approved by the U.S. Food and Drug Administration from about 2001 through March 2007 to compete with Johnson & Johnson’s anemia treatment Procrit.

Aranesp was approved to treat anemia caused by chronic kidney failure and chemotherapy. Amgen marketed the drug for larger, less frequent doses than indicated and for unapproved use in patients with anemia caused by cancer, according to prosecutors.

Amgen was estimated to have reaped about $85 million in gains from misbranding Aranesp, Assistant U.S. Attorney Roger Burlingame said during the hearing. The company pleaded guilty yesterday to a single misdemeanor misbranding charge over the allegations.

“This is serious conduct but it is also misdemeanor conduct,” Burlingame told the judge today.

The case is U.S. v. Amgen Inc., 1:12-cr-00760, U.S. District Court, Eastern District of New York (Brooklyn).

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