General files judgment against Pfizer in drug lawsuit
New Mexico and thirty-two
other states share in $60 million settlement
—OFFICE OF THE ATTORNEY GENERAL
Attorney General Gary K. King has filed a stipulated judgment with
Pfizer Inc. resolving a five-year investigation by thirty-three
states concerning the company's promotion of the "Cox-2"
drugs Celebrex® and Bextra®. In addition to a $60 million
payment to the participating states, with New Mexico's share being
$678,787, the judgment filed in the First Judicial District Court
will largely restrict Pfizer's ability to deceptively promote all
King says, "This judgment, along with our other recent drug
cases, should send a strong message to the pharmaceutical industry
that we will not tolerate deceptive and misleading drug promotion.
The comprehensive injunctive relief obtained in this case is outstanding
and addresses all concerns identified over five years of investigation."
The multistate investigation, organized and led by the Oregon Attorney
General, was initiated in 2003 to determine whether Pfizer and another
drug company Pharmacia, subsequently purchased by Pfizer, misrepresented
that their jointly-sold drug Celebrex was safer and more effective
than traditional non-steroidal anti-inflammatory drugs (NSAIDS)
such as Ibuprofen (Advil®) and naproxen (Aleve®). As the
investigation proceeded, additional concerns were raised regarding
Pfizer's second generation Cox-2 drug Bextra®. Ultimately, the
investigation concluded that Pfizer engaged in an aggressive, deceptive,
and unlawful campaign to promote Bextra® off-label for uses
that had been expressly rejected by the Food and Drug Administration
(FDA). Off-label uses are applications that are not approved by
the FDA. While a physician is allowed to prescribe drugs for off-label
uses, law prohibits pharmaceutical manufacturers from marketing
their products for off-label uses.
The judgment contains injunctive terms addressing all concerns
raised during the investigation regarding both Celebrex® and
Bextra®. Included in the judgment are terms that will help prevent:
• Deceptive use of scientific data when marketing to doctors.
• Distributing samples with the intent to encourage off-label
• Distributing off-label studies and articles in a promotional
• Using patient testimonials to misrepresent a drug's efficacy.
In addition, the judgment requires Pfizer to submit all "direct-to-consumer"
(DTC) television drug advertisements to the Food and Drug Administration
(FDA) for approval and comply with any FDA comment before running
the advertisement. Finally, the judgment generally prohibits Pfizer
from deceptive and misleading advertising and promotion of any Pfizer
drug, requires Pfizer to register all clinical trials, post clinical
trial results, and ensure that subjects in Pfizer-sponsored clinical
trials give adequate informed consent.