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Biotechnology firm Amgen settles kickback allegations for $24.9M

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Biotechnology company Amgen Inc. has agreed to pay $24.9 million to resolve charges under the False Claims Act that it was involved in a kickback scheme with long-term care pharmacy providers, the U.S. Department of Justice said.

The settlement with Thousand Oaks, Calif.-based Amgen, announced Tuesday, settles charges it paid kickbacks to Cincinnati-based Omnicare Inc., and PharMerica Corp. and Kindred Healthcare Inc., both based in Louisville, Ky., in return for implementing “therapeutic interchange” programs designed to switch Medicare and Medicaid beneficiaries from a competitor drug to its own product, the Justice Department said.

The government charged the kickbacks took the form of “performance-based rebates” that were tied to market share or volume thresholds. The DOJ said that as part of the therapeutic interchange programs, Amgen distributed material to consulting pharmacists and nursing home staff encouraging the off-label use of Aranesp, a drug used to treat anemia associated with chronic renal failure, for patients who did not have the condition.

The DOJ said the civil settlement resolves a lawsuit filed under a whistle-blower provision of the False Claims Act that was filed in U.S. District Court in Columbia, S.C.

The DOJ said only allegations were settled by the agreement, and that there has been no determination of liability in the case.

“We will continue to pursue pharmaceutical companies that pay kickbacks to long-term care pharmacy providers to influence drug prescribing decisions,” said Stuart F. Delery, acting assistant attorney general for the Justice Department's civil division, in a statement. “Patients in skilled nursing facilities deserve care that is free of improper financial influences.”

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“By this agreement we are making important strides in holding drug manufacturers accountable for fraudulent and abusive practices not only in South Carolina but nationwide,” said William Nettles, U.S. attorney for the District of South Carolina.

“The conduct alleged in this case is yet another example of the pharmaceutical industry placing marketing goals over patient needs,” said Reuben A. Guttman, a Washington-based director with law firm Grant & Eisenhofer P.A., who represented whistle-blower Frank Kurnick, an Amgen employee, in the litigation, in a statement.

“For situations like this, there has to be a pharmaceutical safety and investigation board to make an even broader report to the public so that this never happens again,” Mr. Guttman said.

Amgen said in a statement that it has “denied all of these allegations that were resolved by the settlement.”

It said the South Carolina settlement is the fourth of five previously disclosed whistle-blower actions filed against it “that were made known to the company in connection with discussions that resulted in an October 2011 agreement in principle to settle different allegations related to Amgen's sales and marketing practices.”

The company said the first of these five whistle-blower suits was settled in December 2012, along with matters covered by the October 2011 agreement in principle. Amgen has been dismissed as a defendant from two of the other whistle-blower suits, according to Amgen. Information about the fifth case is under court seal, an Amgen spokeswoman said.

In a statement issued the Dec. 12, 2012, settlement, the company said it would pay $612 million to resolve its civil liability related to certain promotional practices related to Aranesp as well as several other drugs. It said as part of the settlement agreement with the federal government, 49 states and the District of Columbia, Amgen pleaded guilty to a single misdemeanor count of misbranding Aranesp “by promoting it in a way that was different from the dosages in the label.” The plea was entered in U.S. District Court in Brooklyn.

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