AstraZeneca Pharmaceuticals LP of Wilmington, Del., has agreed to pay a $355 million fine to resolve criminal charges and civil liabilities stemming from an illegal marketing and pricing scheme involving a drug to treat prostate cancer. The massive conspiracy involving the drug Zoladex (goserelin acetate) caused multimillion-dollar losses for federally and state-funded insurance programs and patients.
The FDA's Office of Criminal Investigations (OCI) discovered that AstraZeneca employees were using illegal methods to stimulate the demand for Zoladex by enabling physicians to reap illicit profits.
In one of these schemes, AstraZeneca provided thousands of free samples to physicians, knowing they would charge their patients and insurance programs for them. Another illegal inducement used by the firm involved inflating the price of Zoladex reported to Medicare as the basis for reimbursement, while deeply discounting the actual price charged to physicians. AstraZeneca also misreported and underpaid the Medicaid rebates it owed to the states for the use of Zoladex.
"FDA will not tolerate criminal conduct that exploits patients, plunders the national treasury, and adds to the cost of health care," says FDA Commissioner Mark B. McClellan, M.D., Ph.D. The FDA's OCI was joined by representatives of the U.S. Attorney's Office for the District of Delaware, the Department of Health and Human Services, and the Defense Criminal Investigative Service in announcing the guilty plea in June. The Federal Bureau of Investigation was also involved with the case.
The investigation resulted in charges against three physicians of conspiring with AstraZeneca to bill patients and third-party payers for free Zoladex samples.
COPYRIGHT 2003 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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