Amgen Inc. has agreed to a $71 million settlement with 48 state attorneys general who accused the drugmaker of marketing its anemia drug Aranesp and plaque psoriasis drug Enbrel, both biologic medications, for uses beyond the scope of U.S. Food and Drug Administration (FDA) approval. The drugmaker, based in California, agreed to a consent judgment last month with New York Attorney General Eric Schneiderman and other Attorneys General after they claimed it 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 cells – even though the drug is only approved for more serious forms of the condition.
Aranesp is only approved for treating certain types of anemia, while Enbrel treats a number of conditions including some forms of plaque psoriasis. Attorney General Schneiderman had this to say in a statement:
Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs. 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 its FDA-approved label indicates, and for claiming Enbrel’s effects are more long-lasting than they actually are. The settlement prohibits Amgen from using outlets including drug compendium listings to promote Aranesp and other similar blood stimulant medications, and Enbrel. 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. Of the 50 states, only Mississippi and South Carolina did not participate in the settlement.
Amgen said in its own statement that the settlement with the states addresses some of the very same issues that it had settled with the federal government in December 2012. In the statement, Amgen said:
Separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters. Amgen is pleased to have this matter resolved, and remains committed to fulfilling its mission to serve patients. 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 pled guilty in New York federal court to misbranding Aranesp, and agreed to a combined $762 million civil and criminal payout to resolve long-running allegations about its sales and marketing practices. Federal prosecutors said at the time that Amgen would pay $150 million in criminal forfeitures and penalties for marketing the drug to health care providers for unapproved uses. Meanwhile, lawyers involved in several related civil whistleblower lawsuits said the company had agreed to an additional $612 million in civil settlement payments.
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