The office of New York State Attorney General Eric T. Schneiderman has recently announced that it has reached a settlement with Amgen Inc. with regard to allegations against the company pertaining to the promotion of medications Aranesp and Enbrel for off-label uses. Schneiderman said that Amgen had promoted the said medications for treatment of illnesses or conditions beyond the scope of what has been approved by the U.S. Food and Drug Administration (FDA).
The settlement amounts to $71 million and involves several states including New York, 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, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
Schneiderman said that pharmaceutical companies are not allowed to promote “unapproved and unsubstantiated” claims about their prescription drugs. Moreover, he believes that consumers should be able to feel confident about the accuracy of claims made by drug manufacturers about their product.
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Misleading promotion of drugs
With regards to Amgen, the company promoted its drug Aranesp for the treatment of anemia caused by cancer without getting any approval from the FDA. Moreover, the pharmaceutical company also promoted longer dosing frequencies for Aranesp beyond what the FDA has approved and without any scientific evidence. Aranesp is actually used to treat certain types of anemia.
Meanwhile, Amgen’s drug Enbrel was being promoted for the treatment of mild plaque psoriasis even though the FDA has only approved the said drug for the treatment of chronic moderate to severe plaque psoriasis. Meanwhile, the length of Enbrel’s efficacy in treating plaque psoriasis was also said to be overstated. Enbrel is actually used to treat certain types of plaque psoriasis as well as a number of other conditions.
The Consent Judgement has ordered Amgen to make significant changes on its marketing and promotional practices. From the settlement, New York’s share is reported to be over $3.16 million.