The biotech giant is expected to plead guilty in a New York federal court criminal case. Some reports suggest the charges relate to "misbranding" -- which refers to the promotion of drugs for uses that have not gained the Food and Drug Administration's approval.
The New York Times: Amgen Expected To Plead Guilty In U.S. Case
But one person close to the investigation said Amgen would plead guilty to misbranding, a charge that usually refers to promoting drugs for uses not approved by the Food and Drug Administration. Amgen announced 14 months ago that it had set aside $780 million for a settlement of federal and state investigations and 10 separate whistle-blower lawsuits. Much of the investigations are believed to involve its anemia drugs, Aranesp and Epogen. In more recent regulatory filings, Amgen said the settlement was likely to include an 11th whistle-blower suit, one regarding the marketing of Enbrel, its blockbuster drug for rheumatoid arthritis and psoriasis (Pollack, 12/17).