For Immediate Release
Media Contact: Bob Cooper
(208) 334-4112

Date: October 22, 2008

Idaho To Receive $1.6 Million from Manufacturers of Celebrex and Bextra

(Boise) – The State of Idaho will receive $1,641,482 as its share of a $60 million settlement with Pfizer, the manufacturer of prescription drugs Celebrex and Bextra, Attorney General Lawrence Wasden announced. This is the largest consumer protection settlement the State has obtained outside of the settlement with the tobacco companies. Wasden filed a consent judgment with Pfizer resolving a five-year investigation by 32 states concerning the company’s promotion of these two prescription drugs.

The judgment, filed in the Fourth Judicial District, restricts Pfizer’s ability to deceptively promote all Pfizer products approved by the U.S. Food and Drug Administration (FDA). The consent judgment is subject to court approval.

“This judgment, along with our other recent prescription drug cases, should send a strong message to the pharmaceutical industry that deceptive and misleading drug advertising is not acceptable,” Attorney General Wasden said. “The comprehensive injunctive relief obtained in this case addresses all concerns identified over five years of investigation.”

The multistate investigation was initiated in 2003 to determine if Pfizer and Pharmacia, another drug company, misrepresented that Celebrex was safer and more effective than traditional non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen.

As the investigation proceeded, additional concerns were raised regarding 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 FDA. “Off-label” uses are uses that are not approved by the FDA. While a physician is allowed to prescribe drugs for off-label uses, Idaho law prohibits pharmaceutical manufacturers from marketing their products for off-label uses. In 2005, due to safety concerns, Bextra was withdrawn from the marketplace and the FDA required a safety warning for Celebrex.

Included in today’s consent judgment are terms that will help prevent:

  • Deceptive use of scientific data when marketing to doctors.
  • “Ghost writing” of articles and studies.
  • Failing to adequately disclose conflicts of interest for Pfizer promotional speakers when these consultants also speak at Continuing Medical Education events.
  • Distributing samples with the intent to encourage off-label prescribing.
  • Distributing information about an off-label use when the FDA has rejected the off-label use, unless Pfizer clearly discloses that the FDA rejected the use and the FDA’s reason for rejecting.
  • Distributing off-label studies and articles in a promotional manner.
  • Providing incentives to sales staff to increase off-label prescribing.
  • Promoting drugs off-label for inclusion in hospital standing orders and protocols.
  • Using “mentorships” to pay physicians for time spent with Pfizer sales representatives.
  • Using grants to encourage the use of Pfizer products.
  • Using sales personnel to make grant decisions that are supposedly unrelated to promotion and marketing.
  • Using patient testimonials to misrepresent a drug’s efficacy.

In addition, the judgment requires Pfizer to submit television drug advertisements to the FDA for approval and to comply with any FDA comment before running the advertisement.

Other states participating in the settlement are: Alaska, Arizona, Arkansas, California, Connecticut, Florida, District of Columbia, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin.

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