AstraZeneca pays a king’s ransom to settle allegations of off-label drug marketing

Drug makers AstraZeneca LP and AstraZeneca Pharmaceuticals LP have entered into a monumental settlement with the United States government to resolve charges that the companies illegally marketed the anti-psychotic medication Seroquel.  The government claimed that the Delaware-based companies  promoted Seroquel for “off-label” uses that the Food and Drug Administration (FDA) has not approved as safe and effective.  The marketing of a drug for unapproved uses not listed on the medication’s label resulted in the submission of false claims for payment to Medicaid and Medicare, along with other federal insurance programs and entities including TRICARE, the Federal Employee Health Benefits Program, the Department of Veterans Affairs and the Bureau of Prisons.

To obtain approval for a new drug, a company is required under the Food, Drug and Cosmetic Act to file an application with the FDA that lists all the intended uses of the medication.  The FDA then makes a determination whether the drug is safe and effective to treat the specific conditions named in the application.  Once approval is given, a drugmaker may not market or promote the medication for off-label uses.

Seroquel was originally approved by the FDA  in 1997 to treat manifestations of psychotic disorders.  In 2000, the FDA proposed a restriction of Seroquel’s use only for the treatment of schizophrenia on a short term basis.  In 2004, Seroquel was approved for short term treatment of bipolar-related manic episodes.  In 2006, the drug was approved for bipolar depression.

The government charged that from 2001 to 2006, AstraZeneca illegally promoted Seroquel to psychiatrists and other doctors for a wide range of unapproved uses.  The drug was touted for use in treating Alzheimer’s disease, attention deficit hyperactivity disorder, post-traumatic stress disorder and sleeplessness. AstraZeneca claimed that Seroquel was effective in managing aggression, anxiety,   dementia, depression and mood disorder.  Yet none of these unapproved uses of Seroquel constituted a medically accepted treatment for which the federal drug programs and state Medicaid programs would provide reimbursement.

The United States alleged that as part of its misconduct, AstraZeneca exerted improper influence on the content of continuing medical education programs for doctors not specialized in treating schizophrenia or bipolar disorder, such as elder care, primary care, pediatric and adolescent physicians.  The company allegedly hired physicians to speak at company-sponsored programs promoting unapproved uses of Seroquel.  AstraZeneca retained some doctors to conduct studies on unapproved uses of Seroquel and paid others to claim authorship of articles ghostwritten by medical literature companies about research the claimed authors had not in fact performed.  The pharmaceutical giant then used such studies in its marketing of Seroquel for unapproved uses.

The United States also alleged that AstraZeneca violated the federal Anti-Kickback Statute by making illegal payments to the doctors involved in the company’s improper research practices.  AstraZeneca allegedly paid doctors to make grueling travel to resort locations to meet with company representatives and advise them about marketing the drug for off-label uses.  Doctors were also paid to make promotional lectures to other physicians to persuade them to prescribe Seroquel for uses not approved by the FDA.

The federal government will receive the largest portion of the sizable settlement and the state Medicaid programs and the District of Columbia will share another portion.  The whistleblower who originally exposed the drugmaker’s misconduct by filing a  False Claims Act lawsuit will also participate in the recovery.  That statute’s Qui Tam language encourages private individuals to report corporate fraud against the government by allowing whistleblowers to share in the government’s settlement of False Claims Act suits.

For the full story, go to the Department of Justice’s press release.

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