|The Justice Department has been looking into allegations involving Epogen, Enbrel and Aranesp.|
Amgen's ($AMGN) long-brewing settlement with the U.S. Justice Department is close at hand. The drugmaker pleaded guilty today to a misdemeanor misbranding charge for mismarketing its anemia drug Aranesp. And that plea is part of a deal that includes $150 million in criminal penalties--and a total payment of $762 million.
Though few details about the settlement are available yet, the expectations were that it would involve federal and state investigations and at least 10 whistleblower suits, the New York Times notes. The misdemeanor guilty plea, on a charge of misbranding, is a typical plea for a drugmaker settling marketing allegations.
At $762 million, Amgen's marketing settlement would rank among the biggest in the industry in recent years. It would outrank Serono's $704 million deal on Serostim marketing, but fall short of Merck's ($MRK) $950 million settlement. GlaxoSmithKline ($GSK) currently holds the record at $3 billion.
The Amgen probes and lawsuits have been public knowledge for months, since the company disclosed the investigations in securities filings. The company also disclosed that it set aside $780 million to resolve government investigations and whistleblower suits.
The Justice Department has been looking into allegations that Amgen used "a wide variety of illegal marketing practices" to promote its anemia drugs Aranesp and Epogen. At least one whistleblower has also leveled allegations about its anti-inflammatory blockbuster Enbrel. Another of the 10-plus whistleblower suits alleged that Amgen incentivized doctors to use Aranesp by overfilling vials of the drug. That, in essence, gave physicians additional doses at no cost, which they could then sell to patients for pure profit.
As Reuters reports, the guilty plea involves Amgen's promotion of Aranesp for anemia caused by cancer, an indication not approved by the FDA. The drug was approved to treat anemia caused by chemotherapy. The company was also accused of touting higher doses and different treatment schedules from those the FDA-approved label stipulated.
The settlement now awaits approval from U.S. District Judge Sterling Johnson. His decision is expected tomorrow.
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