Amgen Inc. has agreed to a $71 million settlement with 48 state attorneys general who accused the drug maker of unlawfully marketing its anemia drug Aranesp and plaque psoriasis drug Enbrel, for uses beyond the scope of their Food and Drug Administration’s approvals.
The Thousand Oaks, California-based drug maker agreed to a consent judgment last Tuesday, Law360 reports. New York Attorney General Eric Schneiderman and the others said Amgen has marketed Aranesp for cancer-related anemia without FDA approval and promoted Enbrel to treat mild plaque psoriasis — an auto-immune problem that causes the flaking and scaling of skin— though the drug is approved only for more serious forms of the condition, according to a statement issued by Schneiderman.
Aranesp is approved for treating certain types of anemia, while Enbrel treats a number of conditions including some forms of plaque psoriasis, the statement said. “Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs,” Schneiderman’s statement said. “Consumers need to have confidence in the accuracy of claims made by pharmaceutical companies.” The attorneys general also accused Amgen of promoting Aranesp for different dosage periods than what the FDA-approved label indicates, and for claiming Enbrel’s effects are longer-lasting than they actually are, according to Law360.
Under the terms of the settlement, Amgen is prohibited from using outlets including drug compendium listings to promote Aransep and other 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. Mississippi and South Carolina were the only states that did not participate in the settlement, Law360 says. In its statement, Amgen said the settlement with the states addresses some of the same issues that it had settled with the federal government in December 2012. “Separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters,” Amgen spokeswoman Kelley Davenport said in Tuesday’s statement. “Amgen is pleased to have this matter resolved, and remains committed to fulfilling its mission to serve patients,” she added. “Amgen has a strong compliance program, and our management is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law.”
In December 2012, Amgen entered a guilty plea in federal court in New York to misbranding Aranesp. The company agreed to a combined $762 million civil and criminal payout to resolve long-running allegations about its sales and marketing practices. At the time, federal prosecutors said that Amgen would pay $150 million in criminal forfeitures and penalties for marketing the drug to health care providers for unapproved uses. Attorneys involved in several related civil whistleblower lawsuits said the company had agreed to an additional $612 million in civil settlement payments.