Hawai‘i Reaches Settlement with Biologics Manufacturer

By Maui Now Staff

The state Department of Commerce and Consumer Affairs’ Office of Consumer Protection along with 48 state law enforcement agencies and the District of Columbia announced a major settlement with Amgen Inc. for the promotion of Aranesp and Enbrel.

The $71 million settlement with Amgen resolves allegations that the company unlawfully promoted and mislabeled the medications. Hawai‘i’s share of the settlement is approximately $800,000.

Biologics are a type of treatment made from living things, such as plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules produced using recombinant DNA technology.

Aranesp is a prescription medicine used to treat anemia by stimulating bone marrow to produce red blood cells.

Enbrel is a prescription medicine that decreases a certain protein produced by the immune system, which is used to treat a number of conditions, including rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis.

The complaint and judgment filed today alleges that Amgen violated state consumer protection laws by: promoting Aranesp for dosing frequencies longer than the Federal 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; and promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.

“Improper promotion of off label prescription drugs cannot and will not be tolerated,” said OCP Executive Director Stephen Levins. “It circumvents the strict mandate of the FDA and can lead to significant medical problems, if marketed for inappropriate purposes.”

The consent judgment also requires Amgen to reform its marketing and promotional practices.  For example, 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 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 other states participating in the settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, 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.