$64 million criminal fine paid by AstraZeneca will go to the Department of Justice’s Crime Victims Fund, VOCA --2003: Corporate Integrity Agreement

FOR IMMEDIATE RELEASE

FRIDAY, JUNE 20, 2003

WWW.USDOJ.GOV

CIV
(302) 573-6277

ASTRAZENECA PHARMACEUTICALS LP PLEADS GUILTY
TO HEALTHCARE CRIME; COMPANY AGREES TO PAY
$355 MILLION TO SETTLE CHARGES

The United States Attorney’s Office for the District of Delaware, the Department of Health and Human Services Acting Principal Deputy Inspector General Dara Corrigan, Terrell L. Vermillion, Director, Office of Criminal Investigations, Food & Drug Administration, and SAIC Edward T. Bradley of the Northeast Field Office for the Defense Criminal Investigative Service announced that AstraZeneca Pharmaceuticals LP (“AstraZeneca”), a major pharmaceutical manufacturer headquartered in Wilmington, Delaware, today pleaded guilty in federal district court in Wilmington, Delaware to a healthcare crime and agreed to pay $355,000,000 to resolve criminal charges and civil liabilities in connection with its drug pricing and marketing practices with regard to Zoladex, a drug sold by AstraZeneca Pharmaceuticals LP and used primarily for the treatment of prostate cancer. The general components of the global agreement are as follows:

AstraZeneca pleaded guilty to conspiring to violate the Prescription Drug Marketing Act (“PDMA”) by causing to be submitted claims for payment for the prescription of Zoladex which had been provided as free samples to urologists. This criminal conduct caused losses of $39,920,098 to Medicare, Medicaid and other federally funded insurance programs. As part of the plea agreement, AstraZeneca agreed to pay a $63,872,156 criminal fine;

AstraZeneca agreed to settle its federal civil False Claim Act liabilities and to pay the U.S. government $266,127,844 to resolve allegations that the company caused false and fraudulent claims to be filed with the Medicare, TriCare, Department of Defense and Railroad Retirement Board Medicare programs as a result of AstraZeneca’s fraudulent drug pricing schemes and sales and marketing misconduct; AstraZeneca agreed to settle its civil liabilities to the Medicaid program by paying to the United States and the states a total of $24,900,000 to resolve allegations that it caused false and fraudulent claims to be filed with the states as a result of its drug pricing and marketing misconduct and that it failed to provide the state Medicaid programs AstraZeneca’s best price for those drugs as required by law. The National Association of Medicaid Fraud Control Units has reached an agreement in principle to settle the state portion of these liabilities on behalf of the state Attorneys General; and

AstraZeneca has agreed to comply with the terms of a corporate integrity agreement which ensures, among other things, that AstraZeneca will report to the Medicare and Medicaid programs the average sale price for drugs reimbursed by those programs and will promote, through internal training and other programs and policies, marketing and sales practices that are in full compliance with the law."-2003

"(i) Employees of AstraZeneca provided thousands of free samples of Zoladex to physicians knowing and expecting that certain of those physicians would prescribe and administer the free drug samples to their patients and thereafter bill those free samples to the patients and to Medicare, Medicaid, and other federally funded insurance programs;

(ii) In order to induce certain physicians, physicians’ practices, and others to purchase Zoladex, AstraZeneca offered and paid illegal remuneration in various forms including free Zoladex, unrestricted educational grants, business assistance grants and services, travel and entertainment, consulting services, and honoraria;

(and)

"The entire amount of the nearly $64 million criminal fine paid by AstraZeneca will go to the Department of Justice’s Crime Victims Fund. The Fund was established in 1984 by the Victims of Crime Act (“VOCA”) and serves as a major funding source for victim services throughout the country. Victims of federal as well as state crimes are eligible to receive VOCA-funded services, and state Assistance programs use VOCA funds to provide or contract for services to victims of rape, drunk driving, child abuse, domestic violence, homicide, and other crimes."
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November 2009

Corporate Integrity Agreement

AstraZeneca Pays Millions to Settle Seroquel Cases-NYTimes

"The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel."
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The definition of the word, integrity


in·teg·ri·ty

1. Steadfast adherence to a strict moral or ethical code.

2. The state of being unimpaired; soundness.

3. The quality or condition of being whole or undivided; completeness.
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Corporate Integrity Agreement (CIA): An agreement between the Office of the Inspector General of the Department of Health and Human Services and a health care provider or other entity as part of a settlement for alleged civil wrongdoing relating to Federal health laws.

The government may enter into a CIA with an entity instead of seeking to exclude the entity from Medicare, Medicaid, and other Federal health care programs. Each CIA is unique to the entity, but a typical CIA will last for five years and will require the entity to implement procedures to comply with Federal health care laws, often including developing a compliance plan and hiring a compliance officer.

Several pharmaceutical manufacturers have entered into CIAs in connection with, among other issues, their determination of AWP and Medicaid best price.
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"This above all: to thine own self be true".

William Shakespeare, Hamlet