CHARLESTON – West Virginia Attorney General Patrick Morrisey says his office has participated in a $71 million multi-state settlement with Amgen Inc. to resolve allegations it unlawfully promoted the biologic medications Aranesp and Enbrel.
West Virginia will receive $845,637.82 as part of the settlement, which was negotiated between the company and Attorneys General from 48 states and the District of Columbia. A complaint in the matter was filed Tuesday in Kanawha Circuit Court.
“This settlement is a win for West Virginia consumers,” Morrisey said in a press release. “We enforce our consumer protection laws in a vigorous yet fair manner, and this settlement will help ensure West Virginia doctors and patients aren’t deceived by unlawful drug marketing practices.”
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 settlement allege that Amgen violated state consumer protection laws by:
* Promoting Aranesp for dosing frequencies longer than the U.S. Food and Drug Administration-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.
* Promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.
In addition to the $71 million settlement, the agreement requires the company to reform its marketing and promotional practices, including conditions that it 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 publication or listing in a drug compendium (a nonprofit 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 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.
* 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.
“This settlement agreement will help protect West Virginia consumers by sending a message that we will not tolerate the use of deceptive or improper marketing practices,” Morrisey said.
In addition to West Virginia, the other states participating in this settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, 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, Wisconsin and Wyoming and the District of Columbia.