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Aug. 18 — Amgen Inc. said it has reached a $71 million settlement agreement with 48 states and the District of Columbia that resolves charges that the California-based drug manufacturer unlawfully promoted its biologic medications Aranesp and Enbrel for off-label uses.
The company said Aug. 18 the settlement resolves allegations brought by the states under their own consumer protection statutes. Amgen reached a similar $762 million global settlement agreement with the federal government in December 2012 regarding the firm's marketing practices for Aranesp, Enbrel and other products.
“Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs,” New York Attorney General Eric T. Schneiderman (D) said in a statement Aug. 18. “Consumers need to have confidence in the accuracy of claims made by the pharmaceutical companies.”
Schneiderman's office served on the executive committee of the multistate investigation. All the states with the exception of Mississippi and South Carolina participated in the settlement agreement.
Aranesp is a biologic used to treat certain types of anemia. 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 to use the drug for that class of anemia.
Connecticut Attorney General George Jepsen (D) said in a statement Aug. 18 that the states further alleged that, in order to receive reimbursement from insurance companies and federal programs for the drug's prescription, the company lobbied aggressively for Aranesp to be listed in a drug compendium recognized by the Centers for Medicare & Medicaid Services 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.
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 and 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,” Jepsen said. “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.”
In addition to the payments to the states, the consent judgment also requires Amgen to reform its marketing and promotional practices.
The settlement agreement also bars the company from using a compendium listing or publication to promote Enbrel or any drug in the class as Aranesp for off-label use to a health-care professional, among other restrictions.
The company said in a statement e-mailed to Bloomberg BNA Aug. 18 that the settlement “resolves as to the states under state consumer protection laws some of the same matters that already were resolved as to the federal government by Amgen's December 2012 settlement regarding Amgen's marketing practices for Aranesp, Enbrel, and other products.”
That prior settlement was disclosed in several of Amgen's public filings beginning in 2011.
“Separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters,” the company said.
“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,” the company said.
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