Amgen settles off-label case with states
Amgen will pay $71 million to settle off-label allegations.
Amgen said it will pay $71 million to settle allegations that the biotech drugmaker illegally promoted off-label uses of two of its best-selling brands, Enbrel and Aranesp.
Attorneys general in 47 states and the District of Columbia alleged that Amgen violated state consumer protection laws by promoting anemia drug Aranesp for dosing frequencies longer than what is on the FDA-approved label, engaging in off-label promotion of Aranesp as a treatment for anemia caused by cancer and promoting rheumatology blockbuster Enbrel for mild plaque psoriasis. (Among its multiple indications, the latter drug is approved as a therapy for chronic moderate to severe plaque psoriasis, not the mild form of the condition.)
The allegations in the settlement include claims made by the federal government that were settled by Amgen in 2012. “Amgen is pleased to have this matter resolved, and remains committed to fulfilling its mission to serve patients,” a company spokeswoman said in an email.
The settlement requires the company to reform its marketing and promotional practices.
Drugmakers are not allowed to promote uses of their treatments unless those uses have been approved by the FDA although physicians can legally prescribe drugs off-label to their patients.
A court ruling last week, though, may present new options for pharma companies looking to legally promote off-label uses of their therapies as long as the promotion is considered truthful and is not misleading.