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Post date: August 18 2015

A.G. Schneiderman Announces Multistate Settlement With Pharmaceutical Company Amgen Inc. For Promoting Off-Label Use Of Aranesp And Enbrel

Attorney General Schneiderman, 47 Other State Attorneys General And The District Of Columbia Reached A $71 Million Consumer Settlement With Amgen Concerning Biologic Medications Aranesp® And Enbrel®

New York’s Share Of The Settlement Is Over $3.16 Million

Schneiderman: Consumers Need To Have Confidence In The Accuracy Of Claims Made By Pharmaceutical Companies

NEW YORK - Attorney General Eric T. Schneiderman today announced a $71 million multistate settlement with Amgen Inc. to resolve allegations that the pharmaceutical company unlawfully promoted biologic medications Aranesp and Enbrel for off-label uses.  The Complaint and Consent Judgment filed today alleges that Amgen violated state consumer protection laws by: (1) promoting Aranesp for dosing frequencies longer than the FDA approved label without competent and reliable scientific evidence to substantiate the extended dosing frequencies; (2) promoting Aranesp for anemia caused by cancer without having FDA approval or competent and reliable scientific evidence to support it; (3) promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis; and (4) overstating the length of Enbrel’s efficacy in treating plaque psoriasis. By obtaining a compendium  listing (typically, a non-profit reference book listing a drug’s strengths, qualities and ingredients) for Aranesp for anemia of cancer, Amgen unlawfully facilitated health care coverage and reimbursement for the drug.

“Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs,” said Attorney General Schneiderman. “Consumers need to have confidence in the accuracy of claims made by pharmaceutical companies.”

Attorney General Schneiderman’s Office served on the Executive Committee of this multi-state investigation.  New York’s share of the settlement is over $3.16 million. 

Aranesp is used to treat certain types of anemia by stimulating bone marrow to produce red blood cells.  Enbrel is used to treat a number of conditions, including certain types of plaque psoriasis. 

The Consent Judgment requires Amgen to reform its marketing and promotional practices.  Under the terms of the Consent Judgment Amgen shall not:

  • Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive in promoting Enbrel, Aranesp or any Erythropoietin stimulating agent (“ESA”), a red blood cell stimulant in the same class as Aranesp;
  • Represent that Enbrel, Aranesp or any ESA has any sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities that it does not have; 
  • Use a compendium listing or publication to promote Enbrel, Aranesp or any ESA for an off-label use to a health care professional;
  • Allow Amgen Marketing and Amgen Sales to initiate interactions with a compendium or determine the content of any materials for submissions to a compendium relating to Enbrel, Aranesp or any ESA; and
  • Submit a special supplement to a compendium to support an off-label use of Enbrel, Aranesp or any ESA or use a third party to lobby a compendium on Amgen’s behalf without notifying the compendium that it is acting at Amgen’s request.

The other states participating in the settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.

On behalf of New York, the case was handled by Assistant Attorney General Benjamin J. Lee, Deputy Bureau Chief Laura J. Levine, Bureau Chief Jane M. Azia, all in the Consumer Frauds Bureau, and Executive Deputy Attorney General of Economic Justice Karla G. Sanchez.