(COLUMBUS, Ohio)—Ohio Attorney General Mike DeWine, along with 48 other attorneys general, today announced a $71 million settlement with the pharmaceutical company Amgen over allegations that it unlawfully promoted two of its drugs, Aranesp and Enbrel.
Ohio will receive $1,856,585 as part of the settlement.
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 attorneys general alleged that Amgen violated state consumer protection laws by:
- Promoting Aranesp for dosing frequencies longer than the U.S. Food and Drug Administration (FDA) approved label without competent and reliable scientific evidence to substantiate the extended dosing frequencies;
- Promoting Aranesp for anemia caused by cancer without having FDA approval or competent and reliable scientific evidence to support it; and
- Promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.
“Unlawful promotion of pharmaceutical drugs is a problem we take seriously,” Attorney General DeWine said. “Under this settlement, Amgen has agreed not only to pay millions of dollars to the states but also to make significant changes to the way it promotes these drugs.”
Under the settlement, Amgen agrees to reform its marketing and promotional practices. Specifically, Amgen shall:
- 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;
- Not 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;
- Not use a listing in a publication or compendium (a non-profit reference book listing drug strengths, quality, and ingredients) to promote Enbrel or any drug in the same class as Aranesp for an off-label use to a healthcare professional;
- Not allow Amgen’s marketing and sales teams to initiate interactions with a compendium or to determine the content of any materials for submissions to a compendium relating to Enbrel or any drug in the same class as Aranesp; and
- Not 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.
Participating in the settlement are the attorneys general of: 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, 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.
The proposed settlement (a consent judgment) and a complaint outlining the allegations against Amgen were submitted to the Franklin County Common Pleas Court.
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