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FOR IMMEDIATE RELEASE
October 22, 2008
AG McKenna announces $60 million settlement with Celebrex and Bextra manufacturer

Pfizer accused of deceptively marketing products despite known health risks

SEATTLE – Attorney General Rob McKenna today announced that Washington will receive nearly $1.2 million as part of a $60 million multistate settlement with Pfizer, Inc. The agreement reached with 33 states resolves allegations that the company marketed its anti-inflammatory drugs Celebrex and Bextra for unapproved uses despite known health risks.

“Today’s settlement with Pfizer, combined with our previous agreements with Merck and Eli Lilly, makes it absolutely clear that drug companies can only promote their products for federally approved uses,” McKenna said. “This isn’t just deceptive marketing; ‘off-label’ marketing can create a potential health risk to patients.”

Washington filed its version of the settlement today in King County Superior Court. The agreement resolves a five-year investigation and largely restricts Pfizer’s ability to deceptively promote any of its products. Money received by the states may be used for attorneys’ fees, consumer protection enforcement or education.

Celebrex and Bextra target Cox-2, an enzyme responsible for inflammation and pain. In part because of significant concerns that Cox-2 drugs increase the risk of heart attacks and strokes, the U.S. Food and Drug Administration withdrew Bexta from pharmacies in 2004 and required a “black box” safety warning for Celebrex. Bextra also carries a risk of a serious and sometimes fatal skin condition.

In its complaint, the states alleged that although significant safety concerns led the FDA to reject a request to market high-dose Bextra for acute and surgical pain, Pfizer conducted an aggressive campaign to market the drug for unapproved (“off-label”) purposes. Doctors are allowed to prescribe drugs for uses other than those approved by the FDA but the law prohibits drug manufacturers from marketing their products this way.

Among other things, the states alleged that Pfizer distributed hundreds of thousands of copies of a positive study without disclosing the negative research that was the basis for FDA’s rejection of Bextra. They also accused the company of providing prizes to encourage sales representatives to promote Bextra for off-label uses, co-opting influential doctors with paid consultancies and lavish weekends at high-end resorts, and promoting Bextra for off-label uses during educational programs attended by physicians. The stated allege these efforts continued even after Pfizer completed a study that confirmed FDA’s reason for rejecting the acute and surgical pain indications for Bextra.

Today’s settlement terms require Pfizer to register all clinical and post-clinical trial results and seek FDA approval for any TV ads directed toward consumers or delay advertising if recommended by the FDA. The company is prohibited from doing any of the following:

  • Deceptively using scientific data when marketing to doctors.
  • “Ghostwriting” articles and studies.
  • Failing to adequately disclose conflicts of interest for its promotional speakers who speak at supposedly independent Continuing Medical Education courses.
  • Distributing samples with the intent to encourage off-label prescribing. 
  • Distributing information about an off-label drug use rejected by the FDA unless the company clearly discloses the reason the FDA rejected the use.
  • 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 reps.
  • Using grants to encourage use of Pfizer products.
  • Using sales personnel to make grant decisions unrelated to promotion and marketing.
  • Using patient testimonials to misrepresent a drug’s efficacy.


In addition to Washington, the following states participated in the settlement: 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, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia and Wisconsin.

Complaint

Consent Decree and Stipulated Judgment

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Media Contacts: Kristin Alexander, Media Relations Manager – Seattle, (206) 464-6432

Bob Lipson, Assistant Attorney General, (206) 389-2513

 

 

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