Amgen to Pay $71 Million to Settle Claims of Unlawful Marketing of Aranesp and Enbrel

Forty-eight states and the District of Columbia will share in a $71 million settlement with Amgen Inc. over allegations that the drug maker unlawfully marketed the anemia drug Aranesp and the plaque psoriasis drug Enbrel for unapproved uses.

The drug maker agreed to a consent judgment last Tuesday, Law360 reports. New York Attorney General Eric Schneiderman, along with the 47 other attorneys general, said Amgen marketed Aranesp (darbepoetin alfa) for cancer-related anemia without FDA approval and had promoted Enbrel (etarnecept) to treat mild plaque psoriasis—an auto-immune disorder that causes scaling and flaking of the skin—although Enbrel is approved only for moderate to severe plaque psoriasis, according to Schneiderman.

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. “Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs,” Schneiderman said, adding that “[c]onsumers need to have confidence in the accuracy of claims made by pharmaceutical companies.” In addition to promoting unapproved uses of the drugs, Amgen was also accused of promoting Aranesp for different dosage periods than what the FDA had approved, and claiming Enbrel’s effects are longer-lasting than they actually are, Law360 reports.

Amgen, which is based in Thousand Oaks, California, is required to reform its marketing practices. The company is prohibited from using drug compendiums, which are reference books that list a drug’s strengths, qualities and ingredients, to promote Enbrel, Aranesp, and any red blood cell stimulant in the same class as Aranesp, Schneiderman’s statement said. Further, 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. South Carolina and Mississippi are the only states that did not participate in the settlement, Law360 reports. New York’s share of the settlement is over $3.16 million.

In its own statement, Amgen said the settlement addresses some of the same issues the company settled with the federal government in December 2012. An Amgen spokeswoman, Kelley Davenport, said that separate settlements with state and federal governments are “normal practice” in such legal matters. Amgen is pleased to have the matter resolved, Davenport said. 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 pled guilty in federal court to misbranding Aranesp. The company agreed to a combined $762 million civil and criminal payout to resolve allegations about its 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 paid $612 million in civil settlement payments in related whistleblower lawsuits.

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