The Attorneys General have reached a $71 million settlement with Amgen Inc. to resolve allegations that Amgen unlawfully promoted biologic medications Aranesp and Enbrel. 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 plaque psoriasis. 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; and (3) promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.

“Promoting the use of prescription drugs in ways that are outside FDA approval is irresponsible and potentially harmful to consumers,” says Attorney General Sam Olens. “Consumers deserve to be accurately informed about the medications they are taking so they can weigh the risks and avoid compounding any health problems. This settlement sends the message that consumer safety must not be compromised in the interest of profit.”

The consent judgment also requires Amgen to reform its marketing and promotional practices. For example, 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 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 compendium[1] listing or publication to promote Enbrel or any drug in the same class as Aranesp 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 or any drug in the same class as Aranesp; and
  • submit a Special Supplement to a compendium to support an Off-Label Use of Enbrel or any drug in the same class as Aranesp 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 monies paid to Georgia under the settlement will be $1,687,105.

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

[1] A drug compendium is typically a non-profit reference book listing drug strengths, quality, and ingredients.