The biotech drug giant Amgen pled guilty Tuesday to promoting its blockbuster anemia drug darbepoetin alfa (Aranesp) for off-label dosing regimens, agreeing to pay more than $760 million in fines.
The drug, administered once weekly, was initially approved in September 2001 to treat anemia caused by chronic renal failure.
Knowing it would have trouble competing with the well-established epoetin alfa (Procrit), which is used every other week, Thousand Oaks, Calif.-based Amgen used to its advantage a statement in the product's labeling that said darbepoetin had a longer serum half-life than epoetin alfa, which the company thought might suggest a less-frequent dosing regimen.
Amgen sales representatives promoted darbepoetin for the off-label dose of once monthly, according to the complaint filed Tuesday by the U.S. Attorney's Office in the Eastern District of New York.
Amgen sought and obtained the dosage's listing in the U.S. Pharmacopeia's Drug Information, a compendium allowing the Centers for Medicare and Medicaid Services to reimburse for its off-label use.
"As part of its strategy to increase sales of Aranesp, Amgen instructed its sales representatives to distribute laminated reprints of the Aranesp compendia listing for the [once monthly] QM dose to healthcare professionals with the intent that the healthcare professionals would use Aranesp for QM dosing," the criminal complaint read.
Amgen used a similar strategy in marketing Aranesp for patients with chemotherapy-induced anemia, an indication approved by the FDA for a once-weekly dose in July 2002.
Amgen applied for FDA approval for a biweekly dose of chemotherapy-induced anemia for darbepoetin after the drug gained initial approval. But the FDA did not approve this dose. The company sought FDA approval for a once-monthly dose of anemia in chronic renal failure patients. Again, the FDA never approved the dose, but Amgen continued its marketing tactics.
The FDA found the higher, less frequent dose led to a higher risk of death, the complaint read.
The government pointed to these FDA actions, along with Amgen's off-label promotion that lasted from approval in September 2001 to March 2007, as reasons for pursing its case.
The settlement includes a $612 million civil settlement, a $14 million forfeiture, and $136 million in criminal fines, , which represented the whisteblower, a former Amgen sales representative, in the qui tam case. The U.S. Attorney's Office pegged the criminal fine at $150 million.
"Biotech and pharmaceutical companies, like Amgen, do critically important work," Marshall Miller, acting U.S. attorney for the Eastern District of New York, said in a statement. "That work can extend and enhance the lives of Americans -- or it can place those lives at risk in the pursuit of profits."
Criminal charges against the company include one case of introducing a misbranded drug into commerce.
The plea agreement must be accepted by U.S. District Judge Sterling Johnson, which could be done as soon as Wednesday morning.
As as part of the plea agreement, "Amgen will also enter into a Corporate Integrity Agreement that will make personally accountable Amgen board members and executives, increase corporate transparency, and strengthen its legal compliance structures," Miller said.
"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 2011 and to enter into a corporate integrity agreement," Amgen said in a statement.
Darbepoetin made $1.6 billion in sales for the first 9 months of the year, according to Amgen SEC filings.
"We are pleased with this outcome and believe it will go a long way in preventing Amgen from continuing to violate federal regulations by promoting the off-label use of its powerful drugs and providing medical providers with kickbacks for inappropriately prescribing them," said David Sanford, lead counsel and chairman of Sanford Heisler, in a statement.