KENTUCKY ANNOUNCES $5.5 MLN SETTLEMENT WITH ASTRAZENECA

(The following is a reformatted version of a press release
issued by Kentucky Attorney General Jack Conway and received via
e-mail. The release was confirmed by the sender.) 
ATTORNEY GENERAL CONWAY ANNOUNCES $5.5 MILLION SETTLEMENT WITH
GLOBAL DRUG MAKER ASTRAZENECA 
February 7, 2013 
FRANKFORT, Ky. (February 7, 2013) -Attorney General Jack Conway
and his Offices of Medicaid Fraud and Abuse Control and Consumer
Protection today announced a $5.5 million settlement with
AstraZeneca Pharmaceuticals LP to resolve allegations of off-label marketing of the atypical antipsychotic drug Seroquel.
AstraZeneca, headquartered in London, England, is a global
pharmaceutical manufacturer operating in more than 100
countries. 
The settlement resolves allegations that AstraZeneca illegally
marketed Seroquel for uses the Food and Drug Administration
(FDA) had not approved as being safe and effective. The FDA has
only approved Seroquel for the treatment of schizophrenia and
various bipolar disorders in adults. 
“I am pleased that we have reached this settlement and are
recovering millions of dollars for a vital state program and for
taxpayers,” General Conway said. “We’ve sent a clear message
today that Kentucky will not tolerate drug companies that put
profits ahead of patient care.” 
Under the settlement, the Kentucky Medicaid program will receive
more than $3.3 million.  The remainder of the proceeds will be
distributed on a pro-rata basis to the Kentucky Department for
Behavioral Health, Developmental and Intellectual Disabilities
for certain treatment conducted at facilities across the
Commonwealth, and to the Kentucky Department of Corrections, the
Department for Juvenile Justice, the University of Kentucky
Medical Center and the University of Louisville Hospital.  The
pro-rata distribution is based on the off-label utilization at
the respective agencies. 
AstraZeneca illegally promoted Seroquel’s off-label uses in
children and adolescents well before establishing that the drug
was not safe or effective for any use by those that age.
AstraZeneca also promoted Seroquel for off-label uses for the
elderly, without establishing its safety or effectiveness for
elderly individuals. 
As a result of AstraZeneca’s unlawful marketing and promotion of
Seroquel, utilization of the drug by Kentucky Medicaid
recipients dramatically increased. By August, 2004 more than 25
percent of Seroquel users in Kentucky were under 18 years old
and approximately 15 percent were older than 65.  As part of its
marketing strategy, AstraZeneca sought to induce psychiatrists
to switch from prescribing competing drugs for their patients to
prescribing Seroquel.  AstraZeneca withheld or failed to
disclose negative information concerning the effectiveness of
Seroquel, and withheld or failed to adequately disclose the
risks associated with using Seroquel. 
Medicaid Fraud Recoveries 
Since taking office in January, 2008, General Conway’s Office of
Medicaid Fraud and Abuse Control has recovered or been awarded
more than $292 million for the state and federal Medicaid
programs.  These cases range from lawsuits and settlements
against pharmaceutical companies to cases against individual
providers. 
The Attorney General’s Tip Line for reporting allegations of
Medicaid fraud is 1-877-228-7384. 
Media Contact:
Shelley Catharine Johnson
Deputy Communications Director
502-696-5659 
(sgp) NY 
#<278855.14078.3.4.0.0.76>#
 
 
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