Amgen to Pay $71 Million Over Allegations of Unlawfully Marketing Biologic Medications
AG Healey Joins Multistate Settlement Concerning the Promotion of Medications Used to Treat Certain Types of Anemia and Plaque Psoriasis; Massachusetts to Receive $1.3 Million
BOSTON – Resolving allegations that it unlawfully promoted biologic medications Aranesp and Enbrel for uses not approved by the U.S. Food and Drug Administration (FDA), Amgen, Inc. has agreed to pay a total of $71 million in a multistate settlement, including $1.3 million to Massachusetts, Attorney General Maura Healey announced today.
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.
“Corporations must be held accountable for promoting uses of their pharmaceutical products that have not been established by the FDA to be safe and effective,” AG Healey said. “We are proud to have worked with our state partners to achieve this settlement and bring more than one million dollars back to Massachusetts.”
The complaint, filed today and joined by AG Healey along with 48 attorneys general, alleges that Amgen violated state consumer protection laws by promoting Aranesp for anemia caused by cancer without having FDA approval, and promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.
Under the terms of today’s consent judgment, Amgen is required to reform its marketing and promotional practices and is prohibited from:
- Making any written or oral claim that is false, misleading, or deceptive in promoting Enbrel or any drug in the same class as Aranesp;
- Representing 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;
- Using a compendium listing – or reference book listing drug strengths, quality, and ingredients – or publication to promote Enbrel or any drug in the same class as Aranesp for an off-label use to a health care professional;
- Allowing Amgen’s marketing and sales personnel 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
- Submitting a supplement to a compendium to support an off-label use of Enbrel or any drug in the same class as Aranesp or using a third party to lobby a compendium on Amgen’s behalf without disclosing 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, 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.
This matter was handled for Massachusetts by Assistant Attorney General Eric Gold of AG Healey’s Health Care Division.