AstraZeneca Pays States $68.5M For Off-Label Marketing Of Seroquel Antipsychotic

AstraZeneca Pays States $68.5M For Off-Label Marketing Of Seroquel Antipsychotic

TRENTON, N.J. - (Mealey's) AstraZeneca Pharmaceuticals L.P. and AstraZeneca L.P. on March 10 agreed to pay $68.5 million to 37 states and the District of Columbia to resolve allegations in a New Jersey state court lawsuit that it marketed its atypical antipsychotic drug Seroquel for off-label uses (Paula T. Dow, et al. v. AstraZeneca Pharmaceuticals, L.P., et al., No. MER-C-24-11, N.J. Super., Mercer Co.).

New Jersey Attorney General Paula T. Dow and New Jersey Acting Director of Consumer Affairs Thomas R. Calcagni filed a complaint in the Mercer County Superior Court March 10, alleging that AstraZeneca violated the state Consumer Fraud Act by marketing the drug for off-label uses. 

On the same day, AstraZeneca entered into a final consent judgment.  In addition to paying the 37 states and the District of Columbia $68.5 million, the drug company agreed to stop marketing Seroquel for off-label uses, to publicly post payments to physicians who promote the drug, to have scientific personnel and not sales employees hand out grants and to stop marketing the drug to physicians who are unlikely to prescribe it. 

In addition, the agreement places restrictions on how AstraZeneca will respond to physician inquiries about off-label use of Seroquel.   

The other states that are parties to the settlement are Florida, Illinois, Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.  

New Jersey said AstraZeneca marketed the drug for off-label uses such as pediatric and geriatric patients, nursing home patients, anxiety, depression, sleep disorders and post-traumatic stress disorder. 

The settlement is similar to those reached with federal and state governments for Zyprexa, another atypical antipsychotic drug. 

Atypical antipsychotics carry the risk of excessive weight gain, hyperglycemia and diabetes.  Seroquel, Zyprexa and Risperdal are all the subject of lawsuits by individual patients, third-party payers and federal and state governments. 

The New Jersey Attorney General's Office said the settlement is the "largest-ever multi-state, consumer-protection-based pharmaceutical settlement." 

[Editor's Note:  Full coverage will be in the March 17 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the complaint and final consent judgment are  available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844.  Complaint.  Document #28-110317-004C.  Final consent judgment.  Document #28-110317-005Z.  For all of your legal news needs, please visit www.lexisnexis.com/mealeys.] 

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For more information, call editor Tom Moylan at 215-988-7739, or e-mail him at tom.moylan@lexisnexis.com. 

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