State Office of Consumer Protection Cites Improper Drug Promotion and Labeling for Biologic Medications
HONOLULU – The state Department of Commerce and Consumer Affairs’ (DCCA) Office of Consumer Protection (OCP) along with 48 state law enforcement agencies, and the District of Columbia, announced a major settlement with Amgen Inc. (Amgen) for the promotion of Aranesp and Enbrel.
The $71 million settlement with Amgen resolves allegations that the company unlawfully promoted and mislabeled biologic medications Aranesp and Enbrel.
Biologics are a type of treatment made from living things, like plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules, and are produced using recombinant DNA technolog.
Aranesp is a prescription medicine used to treat a lower than normal number of red blood cells (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 Consent Judgment filed today alleges that Amgen violated state consumer protection laws by: (1) promoting Aranesp for dosing frequencies longer than the Federal Drug Administration (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.
Hawaii’s share of the settlement is approximately $800,000.
“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, under the terms of the Consent Judgment Amgen shall not:
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.
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Department of Commerce and Consumer Affairs
Phone: (808) 586-7582