Amgen Inc. opted to pay 47 US states, including the District of Columbia, with $71 million as case settlement for drug promotion charges, New York Attorney General Eric Schneiderman announced on Tuesday, Aug 18. The pharmaceutical company was accused of illegally promoting two of their products for indications not approved by the US Food and Drug Administration (FDA).
Among the points presented in the accusation against the company include promoting Aranesp to be administered in dosing frequencies that are longer than what has been approved by the FDA, and doing so amidst the lack of sound and accurate scientific proof to warrant such frequencies; advertising Aranesp for the treatment anemia due to cancer without scientific evidence; promoting Enbrel for treating mild plaque psoriasis even if FDA only approved it for mild to severe cases; and amplifying the length at which Enbrel can be effective in managing plaque psoriasis. The company is also said to have unlawfully provided medical care coverage and reimbursement for Aranesp, as per a compendium listing.
"Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs," said Attorney General Schneiderman in the press release. Product buyers must have the certainty in the dependability of the claims released by companies that manufacture the drugs.
Aranesp is a drug indicated for the treatment of anemia. The mechanism of action of this medication is the stimulation of the bone marrow to produce red blood cells. The other drug in question, Enbrel, is administered for a variety of indications, with long-term and severe plaque psoriasis as the most significant use.
Aside from the financial settlement, Amgen is also required to modify its current advertising approach in such a way that the misleading claims are removed and discontinued. Amgen stated that they are glad that this issue has come to a resolution and that their company will continue with their commitment to serve patients.
Amgen has reported that in the second quarter, Enbrel and Aranesp have acquired $1.28 billion and $233 million in sales respectively.
Forty-seven states, including the District of Columbia will receive a portion of the case settlement funds. Each state has varying amount of shares. New York is said to have a total of $3.16 million shares while Ohio will receive $1.9 for Amgen's off-label drug promotion activities.
Photo: Victor | Flickr
