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Public Safety

Attorney 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 Pfizer products.

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 prescribing.

• Distributing off-label studies and articles in a promotional manner.

• 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.

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