Amgen Inc. pled guilty to a misdemeanor count of misbranding its anemia drug, Aranesp, in U.S. district court in Brooklyn on Tuesday, and agreed to pay a total of $150 million in criminal fines and forfeiture. According to the government, the biotechnology company promoted Aranesp for uses that were not approved by the Food and Drug Administration in order to take market share from Johnson & Johnson’s anemia drug, Procrit. Marshall Miller, the acting U.S. attorney for the Eastern District of New York, filed
this criminal information
in the case.
Amgen’s plea deal with the government, as well as settlements of whistleblower suits involving related allegations which remain under seal, are set to be considered for approval at a hearing on Wednesday before U.S. District Judge Sterling Johnson in Brooklyn. Reuters reported
in this story
that in addition to the criminal fines and forfeiture, Amgen had also agreed to a $612 million civil settlement.
Amgen general counsel David Scott offered the guilty plea on behalf of his company at a Tuesday hearing before Judge Johnson. The company is represented by outside counsel at McDermott Will & Emery. McDermott partner David Rosenbloom did respond to our request for comment.
In a teleconference on Tuesday afternoon, acting U.S. Attorney Miller said that the case was “a different type of prosecution” than the government’s conviction of a pharmaceutical sales representative
which was overturned
by the U.S. Court of Appeals for the Second Circuit earlier this month. In that case,
a divided appellate panel found
that drug companies and their representatives have a constitutional right to promote prescription drugs for lawful off-label uses under the First Amendment.
Miller said that though the Second Circuit had found that the communication between the sales reps and doctors was protected speech under the First Amendment, the Amgen case was an instance of a company introducing a product for uses that weren’t approved by the FDA. Miller declined to say whether the Second Circuit’s recent opinion came up during settlement negotiations with Amgen.
A spokesperson for Amgen pointed out that the plea deal is subject to judicial approval and passed along the following statement: “If the court accepts the plea and enters an agreed sentence, Amgen expects immediately thereafter to complete the comprehensive resolution of related civil and criminal matters for which a $780 million charge was recorded in the third quarter of 2011and to enter into a corporate integrity agreement.”
Because the company is only pleading guilty to a single misdemeanor and not to more serious charges, it will not lose access to federal government programs such as Medicare. But under the corporate integrity agreement that’s part of the settlement with the government, the company’s individual board members and executives could be on the hook if there are any future violations.