Amgen Inc. has agreed to pay $71 million to 48 states to settle allegations that the drug maker unlawfully marketed its anemia drug Aranesp and plaque psoriasis drug Enbrel for uses not approved by the Food and Drug Administration (FDA).
The California-based drug maker agreed to a consent judgment last Tuesday, Law360 reports. New York Attorney General Eric Schneiderman and the 47 other attorneys general said Amgen has marketed Aranesp for cancer-related anemia without FDA approval and had promoted Enbrel to treat mild plaque psoriasis — an auto-immune disorder that causes flaking and scaling of the skin— though the drug is approved only for more serious forms of the condition, according Schneiderman’s statement.
Aranesp treats certain types of anemia by stimulating bone marrow to produce red blood cells. Enbrel treats a number of conditions, including certain types of plaque psoriasis. But “[p]harmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs,” Schneiderman’s statement explained. “Consumers need to have confidence in the accuracy of claims made by pharmaceutical companies.” The attorneys general also accused Amgen of promoting Aranesp for dosage periods other than those indicated on the FDA-approved label, and of claiming Enbrel’s effects are longer-lasting than they actually are, Law360 reports.
The settlement terms prohibit Amgen from using outlets including drug compendium listings (a compendium is a reference book listing a drug’s strengths, qualities and ingredients) to promote Aranesp and similar blood stimulant medications, and Enbrel, the attorneys general said. Amgen is also 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. New York’s share of the settlement is over $3.16 million.
South Carolina and Mississippi were the only states that did not participate in the settlement, Law360 reports. In its statement, Amgen said this settlement addresses some of the same issues the company settled with the federal government in December 2012. Amgen spokeswoman Kelley Davenport said, “Separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters.” Amgen is pleased to have the matter resolved, she said, and Amgen “remains committed to fulfilling its mission to serve patients.” Davenport said Amgen has a strong compliance program, and “is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law,” Law360 reports.
In 2012, Amgen pled guilty in federal court in New York 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.