Drugmaker Amgen will pay a total of $71 million to 49 states as part of a settlement over allegations the company illegally promoted two of its biologic medications for off-label uses, the New York Attorney General's Office announced Tuesday.
The states alleged that Amgen violated state consumer protection laws by promoting medications Aranesp and Enbrel for off-label uses—uses for which the drugs were not approved. Aranesp is used to treat certain types of anemia and Enbrel is used for a number of conditions, including plaque psoriasis.
Amgen said in a statement Tuesday that the settlement resolves some of the same matters that were resolved with the federal government in the company's 2012 settlement over marketing of the same drugs. That prior settlement with the federal government reached $762 million.
“Separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters,” Amgen said. “Amgen is pleased to have this matter resolved, and remains committed to fulfilling its mission to serve patients.”
Amgen did not admit to any wrongdoing Tuesday in the settlement with the states, though it pleaded guilty to a criminal charge of illegally introducing a misbranded drug, Aranesp, into interstate commerce in 2012.
The states had accused Amgen of promoting Aranesp for dosing frequencies longer than the FDA approved without competent and reliable scientific evidence; promoting Aranesp for anemia caused by cancer without FDA approval or scientific evidence; promoting Enbrel for mild plaque psoriasis when it's FDA approved for chronic moderate to severe forms of the condition; and exaggerating the length of Enbrel's efficacy.
Under the consent judgment, Amgen may not make claims that are false, misleading or deceptive about the drugs; claim they have any qualities or benefits that they don't actually have; or promote off-label use of the drugs to healthcare professionals through a compendium listing or publication, among other things.
The states share the settlement; New York's piece is more than $3.16 million
The settlement announcement follows a decision in another widely watched case over marketing of off-label drugs that reached the opposite conclusion.
Earlier this month, a New York federal judge ruled that the Food and Drug Administration cannot bar truthful off-label marketing, calling the matter a freedom-of-speech rights issue. That case involved drugmaker Amarin's drug Vascepa, a drug developed to treat cardiovascular health.
Though the FDA prohibits marketing drugs for off-label uses, doctors are allowed to prescribe medications for off-label purposes. In fact, the practice is widespread.
