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Drug Maker Amgen Agrees to $71 Million Settlement of Claims of Unlawful Marketing of Aranesp and Enbrel

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Facing claims of unlawful marketing of the drugs Aranesp and Enbrel, Amgen has agreed to a $71 million settlement with 48 states and the District of Columbia.

The consent judgment was announced last week, Law360 reports. The settlement resolved claims that Amgen had marketed Aranesp (darbepoetin alfa) for cancer-related anemia without FDA approval and had promoted Enbrel (etarnecept) to treat mild plaque psoriasis though Enbrel is approved only for moderate to severe cases of the autoimmune disorder that causes scaling and flaking of the skin.

New York Attorney General Eric Schneiderman was among the attorneys general who announced the settlement. New York’s share of the $71 million is more than $3.16 million. South Carolina and Mississippi are the only states that did not participate in the settlement, Law360 reports.

Aranesp treats certain types of anemia by stimulating the bone marrow to produce red blood cells. Enbrel is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis in adults, and some arthritis in children. In his statement, Schneiderman said, “Consumers need to have confidence in the accuracy of claims made by pharmaceutical companies,” adding that pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs. In addition to promoting unapproved uses of the drugs, Schneiderman said, Amgen promoted Aranesp for different dosage periods than those approved by the FDA and the company claimed Enbrel’s effects are longer-lasting than they actually are, Law360 reports.

The settlement will require Amgen, based in Thousand Oaks, California, to reform its marketing practices. The company is prohibited from marketing Enbrel, Aranesp, and any red blood stimulant in the same class as Aranesp, using drug compendiums, reference volumes that list a drug’s strengths, qualities and ingredients. Amgen is forbidden from using outside lobbyists to facilitate the inclusion of such claims in compendiums without clarifying that they are representing Amgen’s interests, according to Schneiderman’s statement.

Amgen, in its own statement, said the settlement addresses some of the same issues the company settled with the federal government in December 2012. Amgen spokeswoman Kelley Davenport said it is “normal practice” to resolve such legal matters in separate state and federal settlements. Davenport said Amgen is pleased to have the matter resolved. She noted Amgen’s strong compliance program, and said the company is “dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law,” according to Law360.

In 2012, Amgen entered a guilty plea in federal court to misbranding Aranesp. That plea resulted in a combined $762 million civil and criminal payout to resolve allegations about Amgen’s sales and marketing practices, according to Law360. Amgen paid $150 million in criminal forfeitures and penalties for marketing the drug to health care providers for unapproved uses. In addition, the company reportedly paid $612 million in civil settlement payments in related whistleblower lawsuits. disclaimer: This article: Drug Maker Amgen Agrees to $71 Million Settlement of Claims of Unlawful Marketing of Aranesp and Enbrel was posted on Tuesday, August 25th, 2015 at 11:28 am at and is filed under Misleading Information Lawsuits.

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