TRENTON
- Attorney General Paula T. Dow and Criminal
Justice Director Stephen J. Taylor announced
today that New Jersey will receive more
than $9 million in a national Medicaid fraud
settlement with pharmaceutical company Astra
Zeneca Pharmaceuticals LP regarding an illegal
off-label marketing campaign that improperly
promoted the antipsychotic drug Seroquel.
According to Acting Insurance
Fraud Prosecutor Riza Dagli, under the national
settlement, Astra Zeneca will pay the states
and the federal government $520 million
in damages and penalties to compensate Medicaid
and various federal healthcare programs
for harm suffered as a result of the illegal
off-label marketing. The Medicaid portion
of the settlement is $458,660,342.
Medicaid is jointly funded
by the state and federal governments. New
Jersey has reached an agreement in principle
with Astra Zeneca under which the joint
federal and state settlement payment to
the New Jersey Medicaid program will be
approximately $9 million. The state’s
share will be approximately $4.4 million.
“We are committed
to investigating and prosecuting Medicaid
fraud and other abuses affecting our Medicaid
program,” said Attorney General Dow.
“Illegal off-label marketing of drugs
causes Medicaid funding to be diverted from
approved uses to uses that the Food and
Drug Administration have not determined
to be safe and effective.”
The settlement arose from
three federal and state false claim actions
that were consolidated in the U.S. District
Court for the Eastern District of Pennsylvania.
The cases, called qui tam cases, were filed
by private parties on behalf of the government.
New Jersey played an important role on the
team of state Medicaid Fraud Control Units
that worked with the U.S. Department of
Justice to negotiate the settlement. New
Jersey was one of four states that did extensive
claims data analysis which supported the
damage figures.
As part of the civil settlement,
Astra Zeneca will enter a corporate integrity
agreement with the U.S. Department of Health
and Human Services’ Office of the
Inspector General, which will closely monitor
the company’s future marketing and
sales practices.
“In 2009, we recovered
more than $26 million for New Jersey through
national settlements such as this one, in
which our Medicaid Fraud Control Unit played
an important role,” said Acting Insurance
Fraud Prosecutor Dagli. “That is additional
money for our Medicaid program to assist
people who otherwise could not afford vital
health care services and prescription drugs.”
Seroquel was one the first
of a newer generation of antipsychotic medications
called atypical antipsychotics used to treat
certain psychological disorders. Between
September 2001and December 2006, Astra Zeneca
willfully promoted the sale and use of Seroquel
for certain uses which the Food and Drug
Administration had not approved. This is
known as off-label marketing. The marketing
campaign undertaken by Astra Zeneca promoted
Seroquel not only to psychiatrists, but
also to primary care physicians for such
unapproved uses as the treatment of aggression,
anxiety, anger, Alzheimer’s Disease,
attention deficit hyperactivity disorder
(ADHD), bipolar maintenance, dementia, depression,
mood disorder, post-traumatic stress disorder
and sleeplessness.
In implementing the campaign,
Astra Zeneca also made payments and gave
other things of value to physicians and
other health care professionals. As a result
of these promotional activities, Astra Zeneca
caused physicians to prescribe Seroquel
for children and adolescents, dementia patients
in long-term care facilities, and in unapproved
dosage amounts, all of which are uses that
were not medically accepted indications
approved for reimbursement by state Medicaid
programs. Off-label prescribing is a common
practice and is not per se unlawful. However,
pharmaceutical manufacturers are prohibited
from promoting off-label uses of their drugs,
which is what formed the basis of Astra
Zeneca’s liability.
Attorney General Dow credited
Assistant Attorney General John Krayniak,
Senior Counsel in New Jersey’s Medicaid
Fraud Control Unit, with helping to negotiate
the settlement with state and federal authorities.
Attorney General Dow also credited Technical
Assistant B’leia Williams of the Medicaid
Fraud Control Unit for the important role
she played in analyzing claims data. Data
analysis is a critical part of an off-label
marketing case.
In addition to the Senior
Counsel from New Jersey, the team of negotiators
for the National Association of Medicaid
Fraud Control Units included representatives
from Massachusetts, New York, Ohio, California,
Texas and Illinois.
Attorney General Dow noted
that many cases alleging Medicaid fraud
are being filed under New Jersey’s
False Claims Act. She explained that the
New Jersey False Claims Act, like the federal
False Claims Act, contains a whistleblower
provision to provide rewards to people,
often corporate insiders, who blow the whistle
on fraud. New Jersey administers the Medicaid
program through the Division of Medical
Assistance and Health Services in the Department
of Human Services. OIFP’s Medicaid
Fraud Control Unit and the New Jersey Office
of the Medicaid Inspector General investigate
fraud and abuse in the Medicaid program.
### |
