Amgen Inc., a California-based biotechnology company, has agreed to a $71 million settlement with 49 states, including Tennessee, to resolve allegations that the company violated state consumer protection laws.
The settlement, announced by Tennessee Attorney General Herbert H. Slatery III, resolves allegations that Amgen unlawfully promoted two of its medications, Aranesp and Enbrel. According to the Complaint and Agreed Final Judgment, Amgen promoted Aranesp for dosing frequencies longer than the FDA approved label without competent and reliable scientific evidence to substantiate the extended dosing frequencies.
Additionally, Amgen promoted Aranesp for anemia caused by cancer without having FDA approval or competent and reliable scientific evidence to support it. The company also promoted Enbrel for mild plaque psoriasis, despite only being 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. The company is prohibited from making false, misleading, or deceptive claims in promoting Enbrel or any drug in the same class as Aranesp. Amgen is also barred from 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.
The settlement is the result of a multi-state investigation into Amgen’s marketing practices, led by the Tennessee Attorney General’s Office and the Tennessee Division of Consumer Affairs. 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.
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 settlement is a significant step towards holding drug manufacturers accountable for their marketing practices and ensuring that consumers have access to accurate and reliable information about the products they use.
RELATED: Amgen Pays $71M for Pushing Drugs Off-Label
Key Facts
- State: Tennessee
- Agency: Tennessee AG
- Category: Fraud & Financial Crimes
- Source: Official Source ↗
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