Connecticut’s general fund is getting more than $1 million thanks to a multistate settlement reached with a California biopharmaceutical company.
The state joined with 47 others in a $71 million settlement that resolves claims Amgen Inc. illegally marketed two of its medications, Aranesp and Enbrel, Attorney General George Jepsen announced Tuesday.
The states accused Amgen of overstating the effects and benefits of the drugs. Connecticut’s share of the settlement the states reached with the company is $1,026,663, which will go into the general fund, Jepsen said.
The settlement documents show the company denies any liability or wrongdoing.
Aranesp is used to treat certain types of anemia, by stimulating bone marrow to produce red blood cells. The states claimed, however, that Amgen promoted the medication for treating anemia caused by cancer when it did not have U.S. Food and Drug Administration approval for that use.
The state also claimed that Amgen “lobbied aggressively” for Aranesp to be listed in a drug compendium recognized by the Centers for Medicare and Medicaid, in order to get reimbursements for insurance companies and federal programs for prescribing the drug, according to Jepsen. The company then failed to disclose drug trial findings to the compendium which showed increased risk of death and possible tumor stimulation in cancer patients who took the drug for anemia caused by cancer, the states alleged.
Jepsen said the company is no longer marketing Aranesp.
The other drug mentioned in the settlement, Enbrel, is FDA-approved to treat certain types of arthritis and chronic moderate-to-severe plaque psoriasis in adults. Connecticut and the other states accused drugmaker of overstating the drug’s effectiveness and lacking reliable evidence to back claims it treats mild psoriasis.
The FDA sent a warning letter to the company in 2005 about Enbrel advertising, and the FDA also issued warnings about infections and other risks found in patients taking the medication – including lymphoma and other malignant diseases, Jepsen said. Despite that, the states alleged, the company promoted off-label uses for patients with mild plaque psoriasis between 2004 and 2011 and continued to overstate the benefits of the medication.
“Deceptive marketing in the pharmaceutical industry is particularly concerning because, in addition to violating our unfair trade practice laws, it could have potentially significant and dangerous consequences on the health and well-being of those taking the drug,” Jepsen said in a statement.
“The settlement reached with Amgen will help to ensure that this company does not engage in marketing practices for these biologic drugs that could be harmful to patients in Connecticut and across the country,” he said.
The company provided a statement that said, in part: “Amgen is pleased to have this matter resolved, and remains committed to fulfilling its mission to serve patients. Amgen has a strong compliance program, and our management is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law.”
Under the settlement, in addition to paying $71 million to the states, the company has agreed not to: use false or deceptive marketing practices when promoting Enbrel or any drug similar to Aranesp; allow its sales or marketing staff to develop or distribute medical content or determine content that is submitted to a drug compendium; or use a third party to lobby a drug compendium on its behalf, among other stipulations.