Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing
WASHINGTON, April 27 /PRNewswire-USNewswire/ -- AstraZeneca LP
and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve
allegations that AstraZeneca illegally marketed the anti-psychotic
drug Seroquel for uses not approved as safe and effective by the
Food and Drug Administration (FDA), the Departments of Justice and
Health and Human Services' Health Care Fraud Enforcement Action
Team (HEAT) announced today. Such unapproved uses are also known as
"off-label" uses because they are not included in the drug's FDA
approved product label.
The Wilmington, Del.-based company signed a civil settlement to
resolve allegations that by marketing Seroquel for unapproved uses,
the company caused false claims for payment to be submitted to
federal insurance programs including Medicaid, Medicare and TRICARE
programs, and to the Department of Veterans Affairs, the Federal
Employee Health Benefits Program and the Bureau of Prisons.
Under the terms of the settlement, the federal government will
receive $301,907,007 from the civil settlement, and the state
Medicaid programs and the District of Columbia will share up to
$218,092,993 of the civil settlement, depending on the number of
states that participate in the settlement. The allegations were
originally brought in a lawsuit under the qui tam or whistleblower
provisions of the False Claims Act and various state False Claims
Act statutes.
Under the Food, Drug and Cosmetic Act, a company must specify
the intended uses of a product in its new drug application to the
FDA. Before approving a drug, the FDA must determine that the drug
is safe and effective for the use proposed by the company. Once
approved, the drug may not be marketed or promoted for off-label
uses.
The FDA originally approved Seroquel in September 1997 for the
treatment of manifestations of psychotic disorders. In September
2000, FDA proposed narrowing the approval for Seroquel to the short
term treatment of schizophrenia only. In January 2004, the FDA
approved Seroquel for short term treatment of acute manic episodes
associated with bipolar disorder (bipolar mania). In October 2006,
the FDA approved Seroquel for bipolar depression.
The United States alleges that AstraZeneca illegally marketed
Seroquel for uses never approved by the FDA. Specifically, between
January 2001 through December 2006, AstraZeneca promoted Seroquel
to psychiatrists and other physicians for certain uses that were
not approved by the FDA as safe and effective (including
aggression, Alzheimer's disease, anger management, anxiety,
attention deficit hyperactivity disorder, bipolar maintenance,
dementia, depression, mood disorder, post-traumatic stress
disorder, and sleeplessness). These unapproved uses were not
medically accepted indications for which the United States and the
state Medicaid programs provided coverage for Seroquel.
According to the settlement agreement, AstraZeneca targeted its
illegal marketing of the anti-psychotic Seroquel towards doctors
who do not typically treat schizophrenia or bipolar disorder, such
as physicians who treat the elderly, primary care physicians,
pediatric and adolescent physicians, and in long-term care
facilities and prisons.
In March 2006, AstraZeneca brought certain conduct to the
attention of the government and then cooperated in the
investigation of the allegations being settled today.
The United States contends that AstraZeneca promoted the
unapproved uses by improperly and unduly influencing the content
of, and speakers, in company-sponsored continuing medical education
programs. The company also engaged doctors to give promotional
speaker programs on unapproved uses for Seroquel and to conduct
studies on unapproved uses of Seroquel. In addition, the company
recruited doctors to serve as authors of articles that were
ghostwritten by medical literature companies and about studies the
doctors in question did not conduct. AstraZeneca then used those
studies and articles as the basis for promotional messages about
unapproved uses of Seroquel.
"Illegal acts by pharmaceutical companies and false claims
against Medicare and Medicaid can put the public health at risk,
corrupt medical decisions by health care providers, and take
billions of dollars directly out of taxpayers' pockets," said
Attorney General Eric Holder. "This Administration is committed to
recovering taxpayer money lost to health care fraud, whether it's
by bringing cases against common criminals operating out of vacant
storefronts or executives at some of the nation's biggest
companies."
The United States also contends that AstraZeneca violated the
federal Anti-Kickback Statute by offering and paying illegal
remuneration to doctors it recruited to serve as authors of
articles written by AstraZeneca and its agents about the unapproved
uses of Seroquel. AstraZeneca also offered and paid illegal
remuneration to doctors to travel to resort locations to "advise"
AstraZeneca about marketing messages for unapproved uses of
Seroquel, and paid doctors to give promotional lectures to other
health care professionals about unapproved and unaccepted uses of
Seroquel. The United States contends that these payments were
intended to induce the doctors to prescribe Seroquel for unapproved
uses in violation of the federal Anti-Kickback Statute.
"Rooting out health care fraud is a top priority for the Obama
Administration, said Kathleen Sebelius, Secretary of the Department
of Health and Human Services. "Today's settlement sends a clear
warning to any individual or company seeking to defraud our health
care system and returns hundreds of millions of dollars of taxpayer
money to the Medicare trust fund where they belong. It reflects the
unprecedented energy, resources, and new ideas that this
administration has devoted to identifying, prosecuting, and
ultimately preventing health care fraud. With the new
anti-healthcare fraud resources in the Affordable Care Act, there
has never been a worse time to try to steal from our health care
system."
"Consumers are entitled to rely on the claims pharmaceutical
companies make about the drugs they sell," said Tony West,
Assistant Attorney General for the Civil Division of the Department
of Justice. "Working with our federal and state partners, we will
protect the integrity of our public health programs by ensuring
that kickbacks from drug companies do not taint the medical
decisions of health care professionals."
"When pharmaceutical companies interfere with the FDA's mission
to insure that drugs are safe and effective, they undermine the
doctor-patient relationship and put the health and safety of
patients at risk," said Michael L. Levy, U.S. Attorney for the
Eastern District of Pennsylvania. "People have a legal right to
know that pharmaceutical companies are marketing their drugs only
for uses approved by the FDA and that their doctors' judgment has
not been affected by misinformation from a pharmaceutical company
trying to boost revenues."
In addition to the civil settlement agreement, resolution of the
matter includes a Corporate Integrity Agreement (CIA) between
AstraZeneca and the Office of Inspector General of the Department
of Health and Human Services. The five-year CIA requires, among
other things, that a board of directors committee annually review
the company's compliance program and certify its effectiveness;
that certain managers annually certify that their departments or
functional areas are compliant; that AstraZeneca send doctors a
letter notifying them about the settlement; and that the company
post on its website information about payments to doctors, such as
honoraria, travel or lodging. AstraZeneca is subject to exclusion
from Federal health care programs, including Medicare and Medicaid,
for a material breach of the CIA and subject to monetary penalties
for less significant breaches.
"As a result of this Corporate Integrity Agreement, the actions
of AstraZeneca will be more transparent, its Board of Directors
held more accountable, and the names of physicians receiving
payments will be disclosed -- all leading to better protection for
patients," said Department of Health and Human Services Inspector
General Daniel R. Levinson.
The government's investigation was triggered by a whistleblower
lawsuit filed under the FCA's qui tam provisions in the Eastern
District of Pennsylvania. As part of today's resolution, James
Wetta, the whistleblower in that action, will receive more than $45
million from the federal share of the civil recovery.
This settlement is part of the government's emphasis on
combating health care fraud and another step for the HEAT
initiative, which was announced by Attorney General Holder and
Secretary Sebelius in May 2009. The partnership between the two
departments has focused efforts to reduce and prevent Medicare and
Medicaid fraud through enhanced cooperation. One of the most
powerful tools in that effort is the FCA, which the Justice
Department has used to recover almost $2.8 billion since January
2009 in cases involving fraud against federal health care programs.
The Justice Department's total recoveries in FCA cases since
January 2009 are over $3.75 billion.
The civil settlement was reached by the U.S. Attorney's Office
for the Eastern District of Pennsylvania and the Commercial
Litigation Branch of the Justice Department's Civil Division. This
investigation was conducted by the Department of Health and Human
Services Office of Inspector General, U.S. Postal Service's Office
of Inspector General and the FDA's Office of Criminal
Investigations. Assistance was provided by representatives of FDA's
Office of Chief Counsel and the National Association of Medicaid
Fraud Control Units.
Source: U.S. Department of Justice
CONTACT: U.S. Department of Justice Office of Public
Affairs,
+1-202-514-2007, TDD, +1-202-514-1888
Web Site: http://www.justice.gov/
Posted: April 2010
