California-based drug giant Amgen Inc. is paying $71 million to settle allegations it aggressively pushed two of its high-profit medications—Aranesp and Enbrel—for unapproved, off-label uses, misleading doctors and endangering patients across the nation. Tennessee Attorney General Herbert H. Slatery III announced the settlement Tuesday, August 18, 2015, revealing a coordinated crackdown involving 49 states and the Tennessee Division of Consumer Affairs.
The lawsuit charges Amgen with systematically violating state consumer protection laws by promoting Aranesp for dosing schedules longer than the FDA approved, without any solid scientific backing. Worse, the company pushed the anemia drug for use in cancer patients with anemia, despite lacking FDA approval or credible evidence. Enbrel, marketed for severe plaque psoriasis, was pitched to doctors for mild cases—another use never cleared by federal regulators.
At the heart of the case is the manipulation of trust. “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.” The settlement underscores how corporate greed can infiltrate medicine, turning life-saving treatments into profit machines fueled by false claims.
As part of the binding Agreed Final Judgment, Amgen is banned from making any false or misleading claims about Enbrel or drugs in Aranesp’s class. The company can no longer represent these drugs as having benefits, approvals, or uses they don’t have. It’s also barred from using drug compendiums—non-profit reference guides—to promote off-label uses, or allowing its sales and marketing teams to influence compendium submissions without full disclosure.
Amgen must also stop third-party lobbying of compendiums without revealing its involvement. Any special submissions to support off-label use now require transparency. These restrictions aim to dismantle the shadow playbook Big Pharma has long used to skirt FDA rules while raking in billions from unchecked prescriptions.
The settlement includes participation from Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, D.C., 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—proving the scheme was national in reach. The $71 million sum reflects the scale of the fraud, but for patients misled into taking drugs not vetted for their conditions, no payout brings back lost trust.
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Key Facts
- State: Tennessee
- Agency: Tennessee AG
- Category: Fraud & Financial Crimes
- Source: Official Source ↗
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