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AstraZeneca Pharmaceuticals LP, a major pharmaceuticals manufacturer headquartered in Wilmington, DE, pleaded guilty in Wilmington's federal district court to conspiring to violate the Prescription Drug Marketing Act (PDMA). The company agreed to pay $355 million to resolve criminal charges and civil liabilities in connection with pricing and marketing practices regarding Zoladex, a drug sold by AstraZeneca and used primarily for the treatment of prostate cancer. AstraZeneca also agreed to comply with the terms of a corporate integrity agreement that ensures, among other things, that the company will report to the Medicare and Medicaid programs the average sale price for drugs reimbursed by those programs.
From January 1991 through December 31, 2002, employees of AstraZeneca allegedly provided thousands of free samples of Zoladex to physicians, knowing and expecting that certain of them would prescribe and administer the free samples to their patients and then bill the patients, Medicare, Medicaid, or other federally funded insurance programs for those samples. During that same period, AstraZeneca allegedly offered and paid illegal remuneration in various forms such as free Zoladex, unrestricted grants, business assistance grants and services, travel and entertainment, consulting services, and honoraria.
The investigation into AstraZeneca commenced after the filing of a civil False Claim Act suit by Douglas Durand, who was employed as the Vice President of Sales for TAP Pharmaceutical Products, Inc., the manufacturer of the prostate cancer drug Lupron. In October 2001, TAP agreed to pay $875 million to resolve civil and criminal liabilities in connection with its pricing and marketing of Lupron.
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