Bio-pharmaceutical giant Amgen paid more than $15 million last week to resolve allegations that the Thousand Oaks company gave illegal financial incentives to doctors and doctor groups to get them to prescribe the cancer drug Xgeva, federal prosecutors said.
Amgen paid the fine July 11 pursuant to a settlement agreement to resolve allegations that it violated the Medicare anti-kickback statute and the federal False Claims Act, said the office of Andre Birotte Jr., U.S. attorney for the Central District of California.
The Medicare statute prohibits anyone from offering, paying, soliciting or getting anything of value to generate referrals for items or services that are payable by any federal health care program.
Xgeva, also known as denosumab, was approved by the Food and Drug Administration in late 2010 for use in certain cancer patients undergoing chemotherapy.
The drug has also been used to treat osteoporosis as well as certain cancers that have spread to bones.
The FDA in June expanded the approved use of the drug for treating giant cell tumor of the bone.
The drug is one of Amgen's best-selling drugs. Giant cell tumor of the bone is a rare and typically noncancerous tumor.
Prosecutors said Amgen used data-purchase agreements, known within the company as Deep Dive contracts, to provide financial incentives to oncologists and urologists to prescribe Xgeva.
As part of the original plan for Deep Dive contracts, Amgen was to pay doctors to fill out a short survey on the Internet on how they were treating patients with bone cancer, including which drugs were used, whether or not Xgeva was prescribed.
Prosecutors said Amgen altered the original Deep Dive program by increasing the amount of money it would pay doctors and by offering such payments only to doctors who prescribed Xgeva.
Amgen's Xgeva marketing team was not supposed to have access to the identities of doctors who received Deep Dive contracts, prosecutors said.
But team members had access to the information, prosecutors said.
To further influence doctors to prescribe Xgeva, Amgen gave cash payments that it characterized as "honoraria" to oncologists and urologists for participating in data market research surveys, audience response sessions and treatment trend advisory board programs that touted the benefits of Xgeva, prosecutors said.
Last week's settlement resolves a lawsuit filed in 2012 in Los Angeles federal court by two Amgen employees, William Davis and Spencer Miller, under whistle-blower provisions of the False Claims Act, prosecutors said. The act allows private citizens with knowledge of fraud to bring civil actions on behalf of the United States and share in any recovery.
Prosecutors unsealed the lawsuit after the settlement with Amgen.
Davis and Miller together will receive $2.75 million as part of the settlement, prosecutors said. ___