Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

KickerFeaturesSectionsNewsLJN NewslettersPharmaceutical & Medical Device Law Bulletin

AstraZeneca Pleads Guilty in Zoladex Case

By ALM Staff | Law Journal Newsletters |
September 01, 2003

Major pharmaceutical manufacturer AstraZeneca Pharmaceuticals LP pleaded guilty to a large-scale health care crime and agreed to pay $355 million to resolve the associated criminal charges and civil liabilities, according to an announcement released by the FDA Office of Criminal Investigations (FDA OCI) on June 20. The conspiracy involved illegitimate pricing and marketing of Zoladex, a drug for the treatment of prostate cancer. In one of these schemes, AstraZeneca provided thousands of free samples of Zoladex to physicians, knowing that they would charge their patients and insurance programs for the samples. 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 the physicians. AstraZeneca also misreported and underpaid the Medicaid rebates it owed to the states for the use of Zoladex. The various schemes used by the firm caused multimillion-dollar losses to federally- and state-funded insurance programs and individual patients.

AstraZeneca pleaded guilty to criminal conspiracy to violate the Prescription Drug Marketing Act by causing Medicare, Medicaid and other federal providers to be overcharged for Zoladex that had been provided as free samples to urologists. As part of the plea agreement, the company agreed to pay a $63,872,156 criminal fine and to pay $266,127,844 to the U.S. government for claims filed with the Medicare, TriCare, Department of Defense and Railroad Retirement Board programs.

The investigation, which is continuing, also resulted in charges against three physicians of conspiring with AstraZeneca to bill patients and third-party payers for free Zoladex samples. Two of the prescribers have pleaded guilty.

Major pharmaceutical manufacturer AstraZeneca Pharmaceuticals LP pleaded guilty to a large-scale health care crime and agreed to pay $355 million to resolve the associated criminal charges and civil liabilities, according to an announcement released by the FDA Office of Criminal Investigations (FDA OCI) on June 20. The conspiracy involved illegitimate pricing and marketing of Zoladex, a drug for the treatment of prostate cancer. In one of these schemes, AstraZeneca provided thousands of free samples of Zoladex to physicians, knowing that they would charge their patients and insurance programs for the samples. 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 the physicians. AstraZeneca also misreported and underpaid the Medicaid rebates it owed to the states for the use of Zoladex. The various schemes used by the firm caused multimillion-dollar losses to federally- and state-funded insurance programs and individual patients.

AstraZeneca pleaded guilty to criminal conspiracy to violate the Prescription Drug Marketing Act by causing Medicare, Medicaid and other federal providers to be overcharged for Zoladex that had been provided as free samples to urologists. As part of the plea agreement, the company agreed to pay a $63,872,156 criminal fine and to pay $266,127,844 to the U.S. government for claims filed with the Medicare, TriCare, Department of Defense and Railroad Retirement Board programs.

The investigation, which is continuing, also resulted in charges against three physicians of conspiring with AstraZeneca to bill patients and third-party payers for free Zoladex samples. Two of the prescribers have pleaded guilty.

Read These Next
Overview of Regulatory Guidance Governing the Use of AI Systems In the Workplace Image

Businesses have long embraced the use of computer technology in the workplace as a means of improving efficiency and productivity of their operations. In recent years, businesses have incorporated artificial intelligence and other automated and algorithmic technologies into their computer systems. This article provides an overview of the federal regulatory guidance and the state and local rules in place so far and suggests ways in which employers may wish to address these developments with policies and practices to reduce legal risk.

Is Google Search Dead? How AI Is Reshaping Search and SEO Image

This two-part article dives into the massive shifts AI is bringing to Google Search and SEO and why traditional searches are no longer part of the solution for marketers. It’s not theoretical, it’s happening, and firms that adapt will come out ahead.

While Federal Legislation Flounders, State Privacy Laws for Children and Teens Gain Momentum Image

For decades, the Children’s Online Privacy Protection Act has been the only law to expressly address privacy for minors’ information other than student data. In the absence of more robust federal requirements, states are stepping in to regulate not only the processing of all minors’ data, but also online platforms used by teens and children.

Revolutionizing Workplace Design: A Perspective from Gray Reed Image

In an era where the workplace is constantly evolving, law firms face unique challenges and opportunities in facilities management, real estate, and design. Across the industry, firms are reevaluating their office spaces to adapt to hybrid work models, prioritize collaboration, and enhance employee experience. Trends such as flexible seating, technology-driven planning, and the creation of multifunctional spaces are shaping the future of law firm offices.

From DeepSeek to Distillation: Protecting IP In An AI World Image

Protection against unauthorized model distillation is an emerging issue within the longstanding theme of safeguarding intellectual property. This article examines the legal protections available under the current legal framework and explore why patents may serve as a crucial safeguard against unauthorized distillation.