Tennessee Attorney General Herbert H. Slatery III, along with the Tennessee Division of Consumer Affairs and 48 other states, announced on Aug. 18 a $71 million nationwide settlement with Amgen Inc. to resolve allegations that the company violated state consumer protection laws.
Amgen Inc. is a California-based biotechnology company that manufactures and sells pharmaceutical products, including Aranesp and Enbrel.
The settlement resolves allegations that Amgen unlawfully promoted both medications. The complaint and agreed final judgment alleges that Amgen violated the law 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.
“Consumers need to be able to trust that what they are being told accurately describes the product they are buying,” General Slatery said. “This is a health and safety issue and drug manufacturers should be held accountable for misleading and deceptive practices.”
As part of the settlement, Amgen is required to reform its marketing and promotional practices. Under the terms, 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
- Use a compendium 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 (Note: A compendium typically is a non-profit reference book listing drug strengths, quality, and ingredients.)
- 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
- 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
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 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, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.