AG Jepsen: Connecticut Joins $71M Multistate Settlement with
AMGEN Resolving Deceptive Marketing Allegations
Attorney General George Jepsen today announced that Connecticut has joined with 47 other states and the District of Columbia in a $71 million settlement with biopharmaceutical company AMGEN, Inc. to resolve allegations that the company unlawfully promoted two biologic medications, Aranesp and Enbrel.
Aranesp is a biologic used to treat certain types of anemia by stimulating bone marrow to produce red blood cells. The states alleged that AMGEN marketed and promoted Aranesp for treating anemia caused by cancer when it had never received approval from the federal Food and Drug Administration (FDA) to use the drug for that class of anemia.
The states further alleged that, in order to receive reimbursement for insurance companies and federal programs for the drug's prescription, the company lobbied aggressively for Aransep to be listed in a drug compendium recognized by the Centers for Medicare and Medicaid and that the company failed to timely disclose to the compendium findings from drug trials showing an increased risk of death and possible tumor stimulation in cancer patients receiving the drug for anemia caused by cancer. AMGEN is no longer marketing Aranesp.
Enbrel, also a biologic, is approved by the FDA for the treatment of certain types of arthritis and chronic moderate to severe plaque psoriasis in adults. The states alleged that AMGEN overstated Enbrel's effectiveness and lacked competent and reliable evidence to support the drug's use in the treatment of mild psoriasis.
The states alleged that, despite a warning letter from the FDA in 2005 about the company's advertisement of Enbrel, and despite the issuance of FDA black box warnings about invasive infections other risks observed in patients taking Enbrel – including lymphoma and other malignancies observed in children and adolescent patients – AMGEN promoted Enbrel off-label for patients with mild plaque psoriasis from 2004 to 2011 and overstated its efficacy in treatment of plaque psoriasis.
"Deceptive marketing in the pharmaceutical industry is particularly concerning because, in addition to violating our unfair trade practice laws, it could have potentially significant and dangerous consequences on the health and well-being of those taking the drug," said Attorney General Jepsen. "The settlement reached with AMGEN will help to ensure that this company does not engage in marketing practices for these biologic drugs that could be harmful to patients in Connecticut and across the country."
Connecticut's share of the $71 million in settlement funds is $1,026,663.83, which will be deposited in the state's General Fund.
In addition to the settlement funds, the company has agreed to significantly reform its marketing and promotional practices. Under the settlement terms, the company will not:
• Make any written or oral claim that is false, misleading or deceptive in promoting Enbrel or any drug in the same class as Aranesp;
• Represent that Enbrel or any drug in the same class as Aranesp has any sponsorship, approval, characteristics, ingredients, uses, benefits, quantities or qualities that it does not have;
• Use a drug compendium listing or publication to promote Enbrel or any drug in the same class as Aranesp to a proscriber or healthcare professional for an off-label use;
• Allow its sales or marketing staff to develop or disseminate medical content or determine the content of information submitted to a drug compendium;
• Submit any written materials for which AMGEN has paid a journal for placement or publication to a drug compendium to support an off-label use of Enbrel or any drug in the same class as Aranesp; and
• Use a third party to lobby a drug compendium on AMGEN's behalf without notifying the drug compendium that it is acting at AMGEN's request.
Assistant Attorneys General Jose Rene Martinez Onofre, Jeremy Pearlman and Lorrie Adeyemi, head of the Consumer Protection Department, assisted the Attorney General with this matter.