Amgen to Pay $71 Million for Making Misleading Claims

Amgen agreed last week to pay $71 million to 48 states and the District of Columbia to resolve allegations it promoted biologics Aranesp and Enbrel based on misleading claims.

The complaint — filed and settled the same day in each of the states — alleges that Amgen violated state consumer protection laws by promoting Aranesp (darbepoetin alfa) to treat anemia caused by cancer despite lacking FDA approval for the indication. The drugmaker also promoted Enbrel (etanercept) to treat mild plaque psoriasis even though it is approved only as a treatment for chronic moderate to severe plaque psoriasis.

The complaint charges, for example, that Amgen misled consumers by promoting Aranesp to treat cancer-related anemia at dosing frequencies longer than the FDA approved label to compete with Johnson & Johnson’s Procrit (epoetin alfa). Amgen’s decision to settle with the states does not include any admission of wrongdoing.

The deal came less than two weeks after a New York federal judge ruled that Amarin Pharmaceuticals has a constitutional right to promote its cholesterol-lowering drug Vascepa for off-label use as long as the communication is truthful and not misleading. The ruling is specific to the Southern District of New York and the FDA could file an appeal.

Along with the payments, Amgen is prohibited from making any false, misleading or deceptive claims to promote the two drugs or allow marketing and sales personnel to determine the content of any materials submitted to compendium listings.

In December 2012, Amgen agreed to pay $762 million to the U.S. government, 49 states and the District of Columbia over promotional practices involving Aranesp, Enbrel and four other drugs.  The settlement resolved charges that Amgen promoted higher, less-frequent doses of Aranesp than the FDA had approved, and that it marketed the drug for cancer-related anemia, an unapproved indication.

The 2012 case also accused Amgen of promoting Aranesp, Enbrel and a third drug for off-label conditions and giving kickbacks to healthcare providers. Amgen pleaded guilty to a single misdemeanor count of misbranding Aranesp by promoting unapproved dosages.

Amgen said the settlement resolves with the states some of the same matters already resolved in the 2012 case. Separate state and federal resolutions are normal practice is such legal matters. — John Bechtel