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TRENTON
-- Attorney General Anne Milgram announced
today that New Jersey has entered into a
multi-state settlement agreement with Pfizer
Inc. concerning allegations the drug maker
deceptively promoted and marketed its non-steroidal,
anti-inflammatory drugs Celebrex and Bextra.
Under terms of the settlement, Pfizer will
pay New Jersey approximately $2.1 million.
In addition, Pfizer will pay a total of
about $58 million to the other 31 participating
states, including lead state Oregon, and
the District of Columbia.
Filed
today in the Chancery Division of state
Superior Court in Mercer County, the agreement
culminates a five-year, multi-state investigation
into allegations that Pfizer unlawfully
promoted Celebrex and Bextra for “off-label”
uses. Off-label uses are uses not approved
by the federal Food and Drug Administration
(FDA). While a physician is permitted to
prescribe drugs for off-label uses, the
law prohibits drug makers from marketing
their products for such non-FDA-approved
indications.
In
addition to the settlement payment, a Final
Consent Judgment filed with the court today
is designed to prevent the future, deceptive
promotion of Pfizer products by placing
strictures on such practices as the “ghost
writing” of drug-related articles
and studies, deceptive use of scientific
data when marketing to doctors, the awarding
of incentives to corporate sales staff to
increase off-label prescribing by doctors,
the awarding of grants to encourage the
use of Pfizer products and the use of patient
testimonials.
“This
case should send a strong message to the
industry at large that New Jersey does not
tolerate deception and misleading claims
in the promotion of prescription drugs,”
said Attorney General Milgram.
“The
settlement filed today resolves all issues
identified during the multi-state investigation,”
Milgram added. “It is designed to
ensure the safety of New Jersey consumers
by making certain that medical professionals
and patients alike receive accurate, reliable,
impartial information about Pfizer pharmaceutical
products.”
The multi-state investigation was launched
in 2003 to determine whether Pfizer and
another drug company, Pharmacia (subsequently
purchased by Pfizer), misrepresented that
their jointly-sold Celebrex drug was safer
and more effective than traditional non-steroidal
anti-inflammatory drugs such as Ibuprofen
(Advil) and Naproxen (Aleve.)
As the investigation proceeded, additional
concerns were raised concerning Pfizer’s
second-generation anti-inflammatory drug
Bextra. Ultimately, the investigation found
that Pfizer had engaged in an aggressive,
deceptive and unlawful campaign to promote
Bextra for “off label” uses
that were expressly rejected by the FDA,
such as for acute and surgical pain.
Cheap,
generically available anti-inflammatory
drugs have been used for many years to treat
pain and inflammation. However, they have
the potential to cause serious gastro- intestinal
(GI) side effects such as bleeding and perforation.
The drugs Celebrex and Bextra were designed
to reduce pain and inflammation without
the negative GI side effects of traditional
anti-inflammatory drugs. Nevertheless, neither
Celebrex nor Bextra have been shown to be
more effective in relieving pain, or in
significantly reducing serious, use-related
GI problems compared with traditional treatments.
Moreover, there are significant concerns
that Celebrex and Bextra increase the risk
of serious cardiovascular problems such
as heart attacks and strokes. Bextra also
carries a risk of a serious and sometimes
fatal skin condition. In 2004, due to safety
concerns, Bextra was withdrawn from the
marketplace and FDA imposed a requirement
that Celebrex carry a “black box”
safety warning.
New
Jersey and the other participating states
found that, despite FDA’s safety-related
refusal to approve the marketing of Bextra
for acute and surgical pain, Pfizer conducted
a systematic campaign promoting Bextra for
those very uses. Some of the promotional
strategies included:
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The co-opting of influential doctors through
paid consultancies and lavish weekends
at high end resorts.
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Widespread distribution of a positive
study from the denied FDA application
for Bextra (as well as other positive
studies relating to use of high dose Bextra),
without distribution of a negative study
that was the basis for FDA’s rejection,
or the disclosure that FDA had expressly
refused to approve Bextra for acute and
surgical pain.
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The distribution of hundreds of thousands
of samples of high dose Bextra to medical
specialties whose only possible use for
high dose Bextra was off-label.
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The providing of prizes and other incentives
to sales representatives to promote Bextra
off label.
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The use of supposedly independent “Continuing
Medical Education” forums to promote
Bextra off-label.
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The misrepresentation of Bextra’s
safety.
The
states allege that these promotional efforts
by Pfizer continued even after the company
completed its own study that confirmed FDA’s
reason for rejecting Bextra as a drug for
acute and surgical pain. The study ultimately
contributed to FDA’s decision to withdraw
Bextra from the marketplace, even at low
doses that had been previously approved.
In
addition to restrictions on certain promotional
practices, the Final Consent Judgment filed
today requires Pfizer to submit all “direct-to-consumer”
television drug advertisements to the FDA
for approval, and to comply with any FDA
comment before running the advertisement.
If
FDA does not respond within 45 days, Pfizer
may run the advertisement, but must still
comply with any subsequent FDA comments
regarding the advertisement, and must notify
the state that it is running the ad without
FDA authorization. For any new drug for
pain relief, Pfizer must delay direct-to-consumer
advertising for up to 18 months should FDA
recommend such a delay.
Finally, the Final Consent Judgment generally
prohibits Pfizer from deceptive and misleading
advertising and promotion of any Pfizer
drug, requires Pfizer to register all clinical
trials and post clinical trial results,
and ensure that subjects in Pfizer-sponsored
clinical trials give adequate informed consent.
Joining New Jersey and lead state Oregon
in today’s settlement are: Alaska,
Arizona, Arkansas, California, Connecticut,
Florida, District of Columbia, Idaho, Illinois,
Iowa, Kansas, Maine, Maryland, Massachusetts,
Michigan, Montana, Nebraska, Nevada, New
Jersey, New Mexico, New York, North Carolina,
North Dakota, Ohio, Pennsylvania, South
Carolina, South Dakota, Tennessee, Texas,
Vermont, Virginia, Washington, and Wisconsin.
Deputy
Attorneys General Jeff Koziar and Jennifer
Dougherty of the Division of Law’s
Consumer Fraud Prosecution Section handled
the Pfizer matter on behalf of the state.
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